Most of these are short 2-3 minute local news stories on the dangers of FQ’s. Recent videos are listed first. The 30 minute documentary “Certain Adverse Events” and the fictitious movie based on FQ’s “The East” links are included (the film makers got the idea for their drug(s) from reading about FQ news stories). There are also a few non-video news articles thrown in.
I’ve noticed that over time, some of the older links no longer work (even though the stories are still available),and it’s too difficult for me to keep track and keep updating to the new links. In those cases, do an internet search using the title or key words and dates of the stories to find a particular story.
https://www.abcactionnews.com/money/consumer/taking-action-for-you/the-worst-side-effects-of-one-of-the-most-popular-antibiotics-is-buried-in-fine-print The worst side effects of one of the most popular antibiotics is buried in fine print: 122 suicides linked to class of drugs. WFTS ABC-TV News, December 5, 2017. (This same story was also aired on ABC News 5 Cleveland and WPTV5 West Palm Beach and WTMJ Milwaukee and KGUN9 Tuscon). “The warning for this drug and other like it does not include the worst possible side effect: death. Jill Cobb blames one of the most widely prescribed antibiotics in the country for destroying her physically. She suffers from pain so severe in her hip and shoulders she can barely walk. She describes the mental anguish triggered by insomnia and anxiety as devastating as the pain. Cobb says the psychological side effects struck within days after being prescribed Levaquin. Heather McCarthy says her son Shay never experienced mental health issues until a doctor prescribed Levaquin as a preventative following a simple surgery. Within months, Shay dropped out of Purdue University and wound up on more drugs to treat bi-polar disorder. In 2013, he jumped out of a 2nd floor window and ran his car into a concrete barrier. Currently the labels on members of the fluoroquinolone family including Levaquin and Cipro contain warnings that range from depression to insomnia to suicide. Here’s the problem, we found risks buried in the inserts. Take Cipro for example: you’ll find the warning on page 9 of the 31 page insert. Many patients never see the fine print and some of those affected never recover. Eleven months after taking her last dose of Levaquin, Cobb continues to suffer from extreme pain in her tendons. Levaquin’s black box warning includes the risk of tendon rupture but for Cobb the depression and insomnia hurt just as much. The FDA estimates only one to ten percent of those who suffer side effects actually report them. For every Shay McCarthy there could be between 10 and 100 others whose stories go untold.”
https://www.drugwatch.com/podcast/jerry-conway-suffered-aortic-dissection-taking-cipro-levaquin/ DrugWatch Podcast, October 17, 2017: Jerry Conway on suffering from an aortic dissection after taking Cipro and Levaquin. “Prior to taking fluoroquinolone antibiotics Cipro and Levaquin, he was an active, fit 57-year-old man with a good career. But, after he suffered an aortic dissection, he lost everything. On the evening of October 7, 2014, he drove himself to the ER with chest pain. “I was admitted to Plano Presbyterian Hospital’s ER, was given last rites,” Conway told Drugwatch. “I had no idea what was going on.” Fluoroquinolone antibiotics are popular because they treat a wide variety of infections. But, they also have a number of side effects. These include permanent nerve damage, tendon problems and most recently, a connection to aortic aneurysms and dissections — bulges and ruptures in the aorta. Surgeons performed an 11-hour surgery to save Conway’s life. He had suffered an aortic dissection and a heart attack. While he was on the operating table, he had a stroke. Doctors gave him a bleak 5 percent chance at survival. After being in a medically induced coma and four months of rehab, Conway lost his job. He had about $2 million worth of medical bills that forced him to file bankruptcy. He had to live in his car and panhandle when he couldn’t find a job. He filed a lawsuit against the makers of Cipro and Levaquin after he found studies connecting the drugs to aortic aneurysms and dissections. Now, Conway says he is just happy to be alive. He found a job but only makes half of what he used to make before the surgery. Daily, he lives with nerve damage and the after effects of the surgery as well as lingering side effects of the drugs that changed his life forever. He is angry that drug companies never warned him about the dangers of these drugs but tries to stay positive. Conway offers himself as a cautionary tale to others and encourages others to research a drug before taking it.”
http://www.abc15.com/news/state/uti-antibiotic-caused-painful-side-effects-for-valley-woman ABC 15 TV News, Phoenix, Arizona, September 12, 2017 Woman Warns of Painful Side Effects From UTI Medication. “An exclusive twist tonight on a major consumer alert. A Valley woman blames the popular drug Cipro for causing severe health problems. Nancy was prescribed Cipro years ago, repeatedly, for her chronic urinary tract infections. She now attributes the drug to her tendinitis, fatigue, and resistance to antibiotics. “I found out there was a black box warning in 2008, and I told my urologist that there was a black box and he was not aware of it,” she said. “I am a victim of this drug.” The black box warning is on a piece of paper that comes with the drug. The first sentence reads: “This drug may cause very bad side effects.” Nancy and thousands of others know this all too well. Drug companies are facing multiple law suits, and last summer the FDA issued a stronger warning against Cipro in July of 2016, saying the drug should only be used if no other option is available to patients. Nancy was forced to quit her job and is in pain every single day. She wants others to read the warning labels before they assume the antibiotic will help them. “I want people to know that there are drugs out there that they shouldn’t be taking and they need to be their own medical advocate,” she said.”
http://www.wsbtv.com/news/local/clark-howard-says-near-fatal-disease-possibly-caused-by-popular-antibiotic/525314543 WSB TV-2, Atlanta, May 23, 2017: Clark Howard says near-fatal disease possibly caused by popular antibiotic. “Consumer adviser Clark Howard is speaking out about the mysterious sudden illness that threatened his life. The same disease killed a Gwinnett County man. He and Clark had each taken a powerful antibiotic only days before falling ill. Channel 2 Consumer Investigator Jim Strickland exposed the side effects of the drugs 2 1/2 years ago. Clark was admitted to Piedmont Hospital three days after taking the generic antibiotic ciprofloxacin. The brand name is Cipro. He took it to ward off an infection after a biopsy to monitor his prostate cancer. There’s no proof that what happened next is linked to the pill, but Strickland’s research found that it’s happened before. “I felt like death,” Clark said. “It was a struggle to walk five steps.” Clark was admitted to Piedmont and used IVs to flush his system. He said a doctor with 40 years’ experience determined he had rhabdomyolysis. “With rhabdo, your muscles are eating themselves, and then they destroy your kidneys and you die,” Clark said. That’s what happened to Gwinnett triathlete Chris Dannelly in 2013. The disease killed him in five days after he took three pills of ciprofloxacin’s sister drug, levofloxacin. Clark said Piedmont doctors have a working theory that the antibiotic combined with his cholesterol pill, was a bad mix. “The generic Lipitor acted as a catalyst. That caused the supposed problems with Cipro to magnify and give me the rhabdomyolysis,” Clark said. Ten months ago, doctors in Scotland published a similar case involving the two types of pills and a case of rhabdo. Their conclusion: t he consequences of this interaction can have potentially serious outcomes. Clark said he plans to ask about a substitute pill. “Even not knowing for sure whether Cipro was a villain in this or not, why would I want to be dead?” Clark said.”
http://www.ketv.com/article/runners-warn-of-getting-floxed-following-fda-warning-on-antibiotics/9574383 KETV 7 ABC News, Omaha, Nebraska, April 27, 2017: Runners Warn Of Getting “Floxed” Following FDA Warning on Antibiotics: Regulators Warn About Risks of Certain Antibiotics. “The simple act of walking down the street is about as fast as this competitive runner can go now. When you think of the side effects of prescribed medications, nausea, headaches and dizziness come to mind. But for a group of antibiotics, it’s much more severe. These particular drugs can do some damage, possibly permanent, especially for runners and athletes. Omaha police officer, Michael Pecha knows all too well about the side effects of the drugs. When he used to put on his running shoes, he clocked six-minute miles, winning races in high school, college and even now in his 30s. But while training for his first marathon, Pecha believes the antibiotic prescribed for a sinus infection stopped him in his tracks. After four days on the medications, he went out on a run. “I felt an incredibly strong pain in my calf muscles. I stopped, stretched and tried to finish the run and with a half a mile left, I feel the same pain in my other calf and basically limped my way in.” Pecha recalled. That was in January 2016. “Fifteen months later, I’m still experiencing pain in my calves, tingling sensation in my Achilles tendon and numbness in my feet,“ Pecha said. If the antibiotics are to blame, Pecha is not alone. “They might hear a snapping or a popping but it’s very intense, it’s very sudden,” pharmacist Liz Scheffel said. The injury happens in the tendon of not just one, but both legs. “It’s a weight-bearing area of the body, and the drug highly concentrates in those areas,” Scheffel said. The class of antibiotics are called fluoroquinolones. They are common and known as ciprofloxacin or Cipro, levofloxacin or Levaquin, moxiyfloxacin or Avelox. The side effects are so severe, the Food and Drug Administration warns, athletes or not, don’t take the floxacin family antibiotics, unless there is absolutely no another option. While the risk is still considered rare, last year, the FDA also changed the labels on the drugs, warning they are associated with “disabling and potentially permanent side effects of the tendons, muscles, joints and nerves. “It’s called being floxed, “ said physical therapist Claire Rathjen, who runs Core Sports Physical Therapy and Sports Performance. Rathjen helps many athletes rehab and recovery form tendon ruptures and tears. Some patients need surgery. Some have permanent damage. “It can stop a training plan in its track. It can take a competitive athlete out of a season. For some people, it could be a career ending or definitely a season ending injury,” Rathjen said. She said she has seen some athletes come in and don’t understand why they were injured. Rathjen has helped them figure it out, knowing the side effects of the drugs. “It doesn’t matter if we immobilize them or do stretching or loading, they still have inflammation,” Rathjen said, “Then you look back into the history of what they’re taking and it could be the prescription they just finished taking or took six months ago, over a year or two years ago and still having tendon issues.” Runner Chad Lunders experienced the same injuries in both his calves last fall while training for his first marathon. Doctors gave him Cipro and Levaquin while in the hospital with pneumonia and a severe kidney infection. He said his doctor warned him of the side effects. Lunders said he started an easy run when he felt the pain in his calf. He rested for a week and tried to run again and got the same pain in his other calf. “What’s scary is I was on the medications for a short period of time, for nine days, and for it to have those lasting effects,” Lunders said. Lunders is now pain free after three months and will finally get to run his first marathon in Lincoln next weekend. “I’m lucky to have recovered in three months,” Lunders said. As for Pecha, he said he’s accepted he may not be able to run again. He said he’s now more aware of everything he puts in his body and wants others to be mindful too. “It will take a lot of healing, time and patience. I’m trying to stick it out and hoping for a miracle,” Pecha said.”
http://www.kcci.com/article/central-iowa-family-warns-about-dark-side-of-miracle-drug/9574461 ABC KCCI TV8, Des Moines, Iowa, April 27, 2017: Central Iowa Family Warns of Dark Side of Miracle Drug: “We take antibiotics our doctors prescribe — without even looking at the type — to feel better, but what if they made you feel worse? KCCI spoke with a central Iowa family who said there’s a dark side to the miracle drug, and now they have a warning for people like them: Your antibiotics could be bad medicine. “I have to get this out to others,” Paul Headley said. “We have to get this out to others.” There are days that Paul Headley can’t get out of his makeshift bed in the living room. He can’t leave the house. Even climbing the stairway is too painful. “I swallow hard and I think I don’t know if I can make it,” he said. The 57-year-old relies on his cane, a lot different from just eight months ago when he was loving life, riding his Harley motorcycle with his wife, Julie, and having fun with his family. But that’s also when he started forgetting things, developing painful tendon ruptures and becoming an entirely different person. “I just miss him,” his wife, now caregiver, said as she fought back tears. “I miss the stuff we do together.” After dozens of tests and no answers, it came down to one question from a dietitian: Has Paul ever been on the antibiotic Cipro? “We went back about three years, and we got his records and we saw he’d been floxed six times,” Julie Headley said. “That was huge because everything made sense.” Floxed means a patient is given a toxic dose of a fluoroquinolone antibiotic, and Paul Headley had been given two types, Cipro and Levaquin, for an inflamed prostate. Mercy Medical Center pharmacy specialist Dr. Jeff Brock said more people need to read the fine print on the pamphlets that come with prescriptions. “I think they need to be made aware of any antibiotic that patients take, but particularly with fluoroquinolones just because there’s a new what we call black box warning from the FDA,” Brock said. It’s one of the top warnings the FDA issues. It warns not to take fluoroquinolones for “uncomplicated infections.” “When I realized this was the problem, I was just so mad,” Paul Headley said. “I was mad at the world, and I was just so angry that this happened to me.” The Headleys are now working through the pain and the tears to spread the word about the risks and advantages that come with the drugs that so many Iowans take. “They are lifesaving drugs and they need to be there,” Paul Headley said. “There is a purpose for them. However, doctors and pharmacists have to be able to tell you what is going on and let you decide.” Pharmacists know antibiotics help a lot of people, but they also warn “only take antibiotics when they’re needed because we want antibiotics around for a long time,” Brock said. Eight months is all it took for Paul and Julie Headley’s world to change. They still find laughter in the little things. “I sing to him, read to him,” Julie Headley said. But putting water in the refrigerator is hard. Their vow — in sickness and in health — is being tested. And they want you to know that their pain didn’t have to happen. “There isn’t a day that goes by that I think, ‘How can I get this out there to somebody else so they don’t go through what I’m going through?’” Paul Headley said. He doesn’t know if any of his side effects will get better or worse. That’s why the Headleys want people to be more aware of what they’re putting in their bodies and to ask their doctor or pharmacist questions before taking any antibiotic.”
http://wric.com/2016/10/20/patient-advocacy-group-launches-campaign-against-antibiotics-label-changes/ WRIC ABC8 News, Richmond, VA, October 20, 2016: Patient advocacy group warning doctors of dangerous drugs, label changes. A patient advocacy group is taking matters into its own hands after they say the Food and Drug Administration has failed to warn consumers about some potentially dangerous drugs. The Quinolone Vigilance Foundation (QVF) started a “Dear Doctor” letter campaign to alert doctors to new labeling changes for the antibiotics Levaquin, Cipro or Avelox. “We aim to send it to every doctor in the United States,” says Rachel Brummert who was prescribed Levaquin and suffers the permanent effects of the drug, including a stroke just last month. “The FDA has not sent any letters, they have not directed the pharmaceuticals to send out directives, they have done absolutely nothing. What is the use of providing that information if they’re not sending it to the right people,” Brummert said. Just last month, Presidential Candidate Hillary Clinton was prescribed Levaquin for her pneumonia even though the FDA issued the new warnings months earlier. Jonathan Furman, another person permanently affected by these drugs, says, “The effects of these drugs are so devastating and insidious, we felt a personal responsibility to do whatever we could to get as much accurate information we could to as many people as possible.”
http://ici.radio-canada.ca/nouvelles/sante/2016/10/06/001-antibiotiques-risques-effets-secondaires-permanents-fluoroquinolones.shtml French-Canadian Broadcast, Radio-Canada.ca, October 6, 2016 (This video is in French, this is a translation): Antibiotiques: risques d’effets secondaires permanents (Antibiotics: Risks of Permanent Side Effects): Three million Canadians each year receive a prescription for antibiotics of the fluoroquinolone class, better known under the names of Cipro, Avelox and Levaquin. Now, these patients may not be aware that these powerful drugs can involve the risk of serious and potentially permanent side effects. In the US, medical authorities are now recommending that these antibiotics be prescribed as a last resort when it comes to minor infections. In Canada, CBC has learned that Health Canada has initiated a risk assessment. In June 2015, the life of Eric Elliott flipped over completely. At the emergency room, he was prescribed Ciprofloxacin to prevent infection. Within days, his condition deteriorated to the point where an ER physician diagnosed a severe allergic reaction and recommended he discontinue the drug. But a few weeks later, strange symptoms continued to manifest. The 46-year-old lost a lot of weight, his muscles weakened and he suddenly suffered a tendon rupture. “I felt my biceps tendon rupture, it felt like a spring!” he says. Today on his right arm, he carries the most significant manifestation of this like a brand: a long scar, the result of a transplant suffered after rupturing his tendon. Seventeen months later, his daily life consists of chronic joint pain, fatigue, insomnia, and depression. Unable to work, he even had to abandon his profession as a crane operator. While doing research on the Internet, he discovered that all his ailments could be side effects of the medication taken for 10 days. In the US, the Food and Drug Administration (FDA) issued a warning against these drugs in July. Antibiotics of the fluoroquinolone family can cause serious and potentially permanent side effects in the tendons, muscles, joints, nerves and nervous system. These side effects may occur within days or weeks after taking the drug. In fact, according to US health authorities, the risks generally outweigh the benefits sought when the antibiotic is used to fight a minor infection, such as sinusitis, acute bronchitis or a simple urinary tract infection. The FDA is clear: in these cases, fluoroquinolones should only be administered as a last resort. Eric is afraid that he will suffer for the rest of his life and does not understand why these medications are also commonly prescribed in Canada. “It’s poison, it’s a real poison that can destroy us like that. It’s incredible! If someone gives you this, never take it! “, he exclaims. This problem is not insignificant. Dr. Richard Marchand, a microbiologist and infectious disease specialist, is not surprised by Eric’s story. “You’ll have people who will have disastrous effects with these antibiotics. Compared to the number [of antibiotics prescribed], it seems insignificant, but in reality, it is not negligible, “he said. He says that antibiotics are prescribed too often, when they are not needed. “These antibiotics should only be used when necessary, to minimize the dangerous side effects, including tendon rupture, changes in chronic diseases, and neurological problems,” he added. The microbiologist considers it crucial to educate physicians and patients about this so as “not to expose people to unnecessary risks.” This would also help to slow the onset of antibiotic resistance. The same story comes from Dr. Daniel Thirion, a pharmacist at the McGill University Health Centre, who insists that fluoroquinolones are “very important in the therapeutic arsenal”, but that their use should be revised in Canada. Expressing agreement with the FDA’s position, he added that for infections without risk of complications or for simple urinary tract infections, “probably there should be an alternative that should be used instead of fluoroquinolones.” Health Canada has also begun a comprehensive review about fluoroquinolones similar to the FDA’s in November 2015. A scientific advisory committee was established to evaluate the risks and the suitability of these medications to treat certain infections. When asked about this, the College of Physicians of Quebec and the Order of Pharmacists of Quebec are aware of the warning from the FDA, but rely on the recommendations of Health Canada. In a statement, Health Canada says for its part that they have begun “an assessment of the safety of fluoroquinolones to determine if there are potential risks of persistent disability with their use.”
http://www.hr-online.de/website/fernsehen/sendungen/index.jsp?rubrik=54701&key=standard_document_62119560 ARD.de defacto hrFernsehen (German broadcast), October 2, 2016: Gefährliche Nebenwirkungen – Wie gängige Antibiotika die Gesundheit ruinieren (Dangerous Antibiotic: How a Common Antibiotic Can Ruin Your Health) (This is a partial translation): Going for a walk of just a few hundred meters? Andrea can do this only on good days. The Wiesbaden resident is suffering from constant pain, headaches, often sees in double vision, and suffers from panic attacks. She seldom leaves home without her partner Heiko. It’s now been over twenty months that she has suffered from all of these symptoms – ever since she was treated with a certain antibiotic. Andrea says, “[I had] a totally different life. Now, my life is completely destroyed. I keep on nagging myself, why I did allow them to give me that medication? Was it really so bad that I needed it? I am angry, sad and depressed over this whole situation. That it hit me. And why it hit me. I can’t get it out of my head. I often awake from nightmares. It’s not so easy.” She was given Ciprofloxacin for sinusitis. It didn’t help against her infection. Instead one side effect after another started to appear. Even after the first dose, she developed visual problems, hallucinations, panic and pain. For a year after, all she could do was lie down. To this day she takes strong analgesics, and still new side effects keep surfacing. She has manifestations of permanent damage to her tendons and cartilage since the administration of the drug. She says, “They [the doctors] told me the drug would be no problem [ie, no side effects].” Heiko says: “The worst thing is that they gave her a drug that was totally unnecessary.” This is because Ciprofloxacin belongs to the kind of reserve antibiotics which are to be given only in very bad cases when all other antibiotics won’t work. [But this medication] can cause permanent damage. Andrea says, “As I stand here, it’s clear to me in my mind that I realize how my body is destroying itself. This is hard to digest. And there is nothing that anyone can do or to help.” In the US, the FDA has issued the strongest safety warnings for these antibiotics this year, stating they should only be used in serious cases. And in Germany? Here, nothing has happened. The doctors continue to prescribe them easily, and see no need for policy change or action by the authorities.
http://www.newsnet5.com/news/local-news/investigations/family-of-mentor-woman-suspect-popular-antibiotic-prompted-highway-death ABC5 TV News, Cleveland, September 23, 2016: Family of Mentor woman suspect popular antibiotic prompted highway death. “She was just beautiful . . . she was intelligent, vibrant, and happy. She loved life, and she lit up a room. Yes she did, she lit up a room when she came in”, says Deana’s mother. But just months earlier, it all began to unravel. “If she would take a shower, her skin would hurt, like she lost the sensation of warmth and cold.” And tragically, Deana would lose much more. “She parked her car on the side of the interstate, and walked in front of a semi. It was not her. She would have never, ever, done something like that.” She was prescribed Cipro, which has been associated with over 200,000 complaints and over 3,000 deaths. Last May, the US Food and Drug Administration issued new warnings and label changes for drugs like Cipro that belong to a family of antibiotics known as fluoroquinolones. “Serious side effects,” warned the FDA, “outweigh the benefits for many patients.” But for Deana, the warnings came too late. “She specifically told us, that she asked the doctor if there would be any side effects, and the doctor said absolutely not, it’s a common antibiotic.” Dr. Charles Bennett says, “Even as few as one or two doses, can develop serious, permanent, disabling physical and psychiatric toxicities. These are things like unable to work, unable to concentrate, body pain, severe pain, and very very disabling.” That’s exactly what happened to Deana. “After the very first dose, she had a severe reaction, the very first dose.” And the symptoms grew even more severe, leading up to her death. “She developed excessive ‘skin crawling , she would beg me ‘Mom, please keep me safe, please keep me safe’. Her husband and I would take turns, keeping 24/7 watch on her.” And Deana is not an isolated case. We found 600 suicide cases reported to the FDA, and the number could be much higher. “There is absolutely no doubt that the medication did this to my daughter. My daughter’s death cannot be in vain. Nobody else should suffer something like this, it’s just unconscionable for this to be happening when the information is out there.”
http://www.theindychannel.com/news/local-news/hillary-clinton-taking-antibiotic-with-black-box-warning ABC WRTV6 News, Indianapolis, September 15, 2016: Hillary Clinton taking controversial antibiotic with “Black Box” warning. Didn’t the FDA just announce big warnings for this medication? They sure did. An FDA safety review found the drugs can cause serious, disabling, and potentially permanent side effects involving the tendons, muscles, joints, nerves and central nervous system. Call 6 Investigates reached out to the Clinton campaign, but they have not yet responded, so it’s unclear if Clinton was aware of the new FDA “black box” warnings when she started taking Levaquin. Dr. Charles Bennett, a vocal critic of Levaquin who has not treated Clinton, said her doctors should examine the presidential candidate for possible side effects including muscle weakness. Clinton recently raised concerns when she appeared to struggled to walk while leaving a 9/11 ceremony. “It could be a serious drug reaction,” said Bennett. “The best thing to do is stop the drug, I would suggest, if it’s a potential serious adverse drug reaction. You can use many other antibiotics for pneumonia. I would defer to her physicians there.” Bennett said he is surprised Hillary Clinton was prescribed Levaquin, given the recent label changes and serious side effect concerns. “Our data estimates the FDA receives several thousand reports per year of this toxicity, and several thousand deaths,” said Bennett. “This is equivalent to a 747 plane going down once a month.”
http://www.wsbtv.com/news/local/atlanta/drug-prescribed-to-hillary-clinton-to-treat-pneumonia-was-subject-of-channel-2-investigation/446395106 WSB TV2 Atlanta, September 15, 2016: Drug prescribed to Hillary Clinton to treat pneumonia was subject of Channel 2 investigation. Democratic presidential nominee Hillary Clinton is now taking an antibiotic with side-effects so risky, the FDA put out new warnings about the drug less than two months ago. Her doctor says the drug Levaquin is treating Clinton’s pneumonia. Channel 2 Consumer investigator Jim Strickland first exposed trouble with the drug nearly two years ago. Strickland’s sources alerted him to Clinton’s 10-day regimen on the drug. “She indeed was given Levaquin, and I think that’s just crazy,” said side-effect sufferer Nicole Delaine. Her testimony to an FDA panel helped sway the agency to issue the new warnings. The drug left her unable to walk for a time. The side effects are potentially so severe, that 2 pills are blamed for the death of Chris Dannelly of Duluth. “Using it for a non-life-threatening infection is just dangerous,” she said. Critics of the drug wonder whether Clinton’s light headedness and stumble on Sunday were more about her prescription than her illness. “Many docs say, ‘Let’s just use this and use a super drug, and go out there and treat,'” said drug watchdog Dr. Charles Bennett. Bennett is a vocal proponent of even more warnings, and has petitioned the FDA to take action about the drug’s effect on the brain and on human cells. As of July 26, the FDA warned that doctors should limit the use of Levaquin and other fluoroquinolone medications “in patients with less serious bacterial infections.” Clinton’s doctor described her pneumonia as “mild.” The FDA warnings do not list pneumonia among the conditions doctors should treat with other pills. Bennett said that out of caution for Clinton’s future health, her doctor ought to switch the medication. “There are plenty of alternative antibiotics that are far safer to use than Levaquin for this kind of pneumonia,” Bennett said. The FDA never notified doctors directly of the new labeling changes. Strickland emailed the medical practice where Clinton’s doctor works to find out more about why Levaquin was prescribed and whether they knew of the updated warnings. He has not received a response.
http://wric.com/2016/09/15/clinton-prescribed-drug-fda-warns-could-cause-serious-permanent-damage/ WRIC-ABC8 News, Richmond, VA, September 15, 2016: Candidates and their health: New concerns for Clinton. Presidential Candidate Hillary Clinton has been prescribed the controversial drug Levaquin, a drug 8News has exposed to cause serious permanent damage in some cases — including problems with the central nervous system. That prompted the FDA in May to issue a new warning about the drug, which is part of a group of powerful antibiotics known as fluoroquinolones. Clinton has been advised to take the drug for 10 days for her pneumonia. In May, the FDA responded by issuing new label changes for the drugs, stating the antibiotics have been associated with disabling and potentially irreversible adverse reactions including tendon ruptures and problems with the central nervous system. The Quinolone Vigilance Foundation issued this statement: “We are concerned about anyone who is prescribed a fluoroquinolone antibiotic such as Levaquin, Cipro, and Avelox. They can be associated with severe, often permanent, adverse events and should be reserved for the most serious, life threatening conditions for which there are no safer alternatives. Fluoroquinolone adverse effects do not discriminate and can affect anyone at any time. While recent labeling changes from the Food and Drug Administration (FDA) on fluoroquinolone antibiotics are a big step in the right direction, the news of Secretary Clinton being prescribed Levaquin will hopefully start a national conversation highlighting the need for full disclosure of risks, contraindications, and about the over-prescribing of antibiotics leading to antibiotic resistance. We wish Secretary Clinton a full recovery with no adverse effects from the use of Levaquin.”
http://www.rbb-online.de/kontraste/archiv/kontraste-15-09-2016/gefaehrliche-antibiotika-arzneimittelbehoerden-versagen-bei-patientenschutz.html News story from Berlin, Germany, September 15, 2016: Gefährliche Antibiotika: Arzneimittelbehörden versagen beim Patientenschutz (Dangerous Antibiotics: Drug Regulatory Agencies Fail to Protect Patients). (Note: this story is in German, the following is not a full translation, but covers most of it). Stefan can hardly walk. Every step is torture, and his Achilles tendons could tear at any time. The 30 year old has joint and tendon pain, and his hands and feet burn. He has anxiety, blurred vision, and difficulty concentrating. He developed these side effects after taking certain antibiotics. Stefan says: “It’s like my whole worldview collapsed. Before, I was able to work, I could do sports, I could take care of the household; afterwards, none of that is possible at all. I need help with every little thing, and I live in a world of pain.” Most of the time, he can only spend laying down. Eight months ago he was prescribed the antibiotics Ciprofloxacin and Levofloxacin for burning urination. He didn’t realize how dangerous these drugs could be. He says: “I’m very angry that such drugs were given for a simple urinary tract infection, drugs which could lead to permanent damage and destroy the rest of my life.” The American FDA has imposed the highest security alert this year: this group of antibiotics should no longer be used for minor infections because of the dangerous side effects. And in this country? No current warnings by the German Drug Administration. Despite the high risks, many doctors continue to prescribe Ciprofloxacin and Levofloxacin for simple infections. Wolfgang Becker-Brüser, from the independent scientific journal “Arzneitelegramm”, has been warning about the side effects of these antibiotics since the 90’s. He accuses the regulatory authorities of inaction. “If it is clear that thousands of people are injured, perhaps even tens of thousands, then action must be taken. Any chance of this is too great, and strategies to protect patients and preventative consumer protection must be sought and found.” In the US, there is now a bold and framed warning in the top of the package insert of Cipro, the so-called “Black Box Warning”. In it the risk of irreversible damage is highlighted. It also says explicitly that Cipro should not be the drug of first choice. Dr. Charles Bennett, a US Medical Pharmacologist Expert, thinks this is absolutely necessary. Bennett says: “The new and revised boxed warning presents the serious side effects on the central nervous system. Patients can no longer work after one or two tablets of these drugs, they can no longer think and have insane pain. This black box warning on the package insert stands out to the eyes – both the doctors and the patients.” But in the German package insert of Ciprofloxacin, one will not see these conspicuous warnings. Instead, broad areas of use are still promoted. This is incomprehensible, because fluoroquinolones are supposed to be used only against serious infections if there are no alternatives. We asked the German drug authority BfArM as to why it has not issued any current alert to this antibiotics group. We did not get an interview, but we were told the side effects are listed in detail on the package insert, and that a highlighted warning as in America does not make sense here. Wolfgang Becker-Brüser says: “It’s not sufficient this information [is buried] in the package insert or in the prescribing information. There’s so much in there, that no one, not a consumer and no doctor, can see everything that’s in there. There is important [information] as well as unimportant [information], there is life threatening [information] as well as banal [information]. That is why a black box is a very good arrangement in the US. A Black Box tells you you exactly what is life-threatening and severe, and warns the doctor what has to be avoided. ” Sven, another affected patient, says no one clarified that these antibiotics should not be taken for minor infections. Also, nothing about the potential damage [these drugs cause] was in the package insert. Sven can just go to the mailbox – that’s all he manage. He and many other injured patients have now made a petition. They demand that the use of these antibiotics be highly restricted. Sven says: “I really feel like I’ve been surreptitiously poisoned, poisoned sneakily, without ever being warned. I was prescribed the drug by a physician. I was warned neither by the doctor nor the receptionist nor the pharmacist [about these adverse effects]. All of them said that [the drug] is well tolerated, but it was not [for me]. I’ve been unable to work for four months.” Sven wrote to the German Minister of Health. But he received no response to his petition. For Stefan, [quoted at the start of this story], it turns out his ailment actually had no need for antibiotic use, as he found out later. There is no treatment for the damage that was done by the prescribed remedy. His prognosis is uncertain.
http://www.wsbtv.com/news/2-investigates/doctors-may-not-hear-new-warnings-about-powerful-antibiotics/415229950 WSB TV2, Atlanta, August 1, 2016: Doctors May Not Hear New Warnings About Powerful Antibiotics. It was big news when the FDA put out new warnings about fluoroquinolone drugs, about the side effects which can cause tendon damage, nerve damage, even cause death. But here’s the problem learned today: The FDA never told doctors directly about this. Federal regulators have no plan to formally notify individual doctors about the new warning label. Rather than notify the medical community in writing, they are relying on press releases and online newsletters to get the word out. “They are prescribing it like candy” says Celeste. Her husband had tendon pain so bad from Cipro, they had to install a chair lift. “After the first dose, it felt like shin splints, and that just got worse as the weekend went on. I think they should make all the doctors very much aware and not let them just continue to prescribe it as they have in the past.” A new FDA warning label tells doctors the risk of side effects is too great to make the drug the first choice to treat common illnesses like sinusitis and urinary infections. One problem: Medical watchdog Dr. Charles Bennett says: “A “Dear Doctor” letter was not authorized. How would you know that there’s a change in the label? It does not make sense. Most doctors are too busy to notice.” The American Cancer Society here in Atlanta is giving Dr. Bennett a grant so he can develop a DNA test that will be able to determine if a patient is at risk for the side effects of fluoroquinolones.
http://www.foxcarolina.com/story/32566954/fda-releases-new-warning-about-common-antibiotics Fox News, Greenville, SC, July 28,2016: FDA releases new warning about common antibiotics. His doctors gave him Levaquin for his sinus infection. Then he noticed something strange. “Two days after starting the medication, my Achilles tendons became very very sore. And it almost felt strained, and so I cut back on all my physical activities at that point. I felt a lot of pain behind the heel, and it’s alarming enough that I mentioned it to my doctor”. So he got off the drug and switched to another. But it turns out the FDA has issued warnings about Levaquin since 2008. This week, the warnings were increased. Some patients are lucky. Rashida says: “I took it (Cipro), and the symptoms began to ease up, and I didn’t have any side effects or anything”. Dr. April Treas: “The FDA’s guidance is not that we stop using them entirely, but that in certain scenarios, they are not the best option.”
http://www.cw6sandiego.com/fda-strengthens-warnings-on-potentially-dangerous-family-of-antibiotics/ FDA strengthens warnings on potentially dangerous family of antibiotics. CW6 San Diego, July 28, 2016: They go by the names Levaquin, Avelox and Cipro . . . Many people have suffered life altering side effects with no explanation as to why they had a predisposition for the violent reaction. The FDA is now warning of potential disabling side effects of the antibiotics, saying the risks far outweigh the benefits for patients suffering from less serious infections like sinusitis, bronchitis or urinary tract infections. “It’s severely limited my life, there’s no sugar coating that”. Matt is still struggling to cope with his adverse reaction to the antibiotic Cipro 2 years ago. “I biked a lot, I ran to and from work, which is about a mile, pretty much every day”. The once active 26 year old biked and walked to work at his dream job as a computer programmer in Seattle, but 2 years ago he became debilitated after an ER doctor prescribed Cipro. He says he immediately felt weaker. “So I just took it, and after a couple of days, I couldn’t walk uphill, it just got worse, I started getting short of breath just walking, I started getting tendon pains, like in these tendons and these tendons on both sides, I can’t play piano because my hands just start hurting too much”. With his health and mobility deteriorating, he was forced to quit his job and move back home to San Diego. “My reaction to Cipro, whatever predisposed me to Cipro, has harmed my ability to have a normal life. I think the FDA warning, to not take it unless it’s a last resort for a standard infection, I think that’s smart, I think people should not, and I think most doctors would agree with me once they know what it really does to people.” He shares the journey of thousands of Americans reportedly poisoned by fluoroquinolones, some 10,000 strong on active online support groups.
http://longisland.news12.com/news/fda-approves-strong-warnings-on-levaquin-similar-drugs-1.12100797 TV12 News, Long Island, July 27, 2016: FDA Approves Strong Warning on Levaquin, Similar Drugs. Shira says she took Levaquin for a sinus infection, and began having headaches and vision problems. Doctors discovered she had excess fluid on her brain, and she needed a spinal tap to relieve the pressure. “Some blurred vision, some spotty vision, and then very suddenly, I started seeing double.” Dr. Aaron Glatt: “The idea behind all these warnings, is that don’t use these drugs if there are other choices.”
http://www.newsnet5.com/news/local-news/investigations/fda-issues-updated-label-warnings-for-levaquin-cipro-antibiotics FDA Issues Updated Label Warnings for Levaquin, Cipro Antibiotics. TV News ABC 5 Cleveland, July 26, 2016. The FDA issued updated warnings on Tuesday for some of the most prescribed antibiotics on the market due to disabling and potentially permanent side effects.
http://thefacts.com/free_share/article_2162bad8-562b-5124-aab7-3885e79dfe1e.html (This is a news article, not a video), July 10, 2016: WHEN THE CURE IS WORSE: Lake Jackson woman reaches out about danger of prescription drugs. For Glennece Beckett, the nightmare started in June 2014 with a urinary tract infection. She didn’t think much of it, since UTIs are so common, and her doctor was similarly unconcerned. She received a prescription for ciprofloxacin, a fluoroquinolone antibiotic often used to treat such infections, and trusted that the seven-day course of pills would clear up her problem. After a week of pills, the infection faded, but other problems soon took its place. Burning pain filled the joints of her hands, arms and elbows. The joints in her feet and ankles began to swell, creating throbbing pain when she tried to walk. Her stride turned into a hobble. For an active woman involved in biking, running and horseback riding, it was a serious liability. Eventually, Beckett went to a Houston orthopedist to find out what was wrong. He asked if she had taken Cipro, a brand name for ciprofloxacin. “Things just deteriorated from there. … I went through a year ripping tendons,” she said. “If I sat up for more than 30 minutes, the tendons that hold the muscles to the backbone would shred and rip. I turned over in bed and the tendon ruptured in my right thigh and the muscles ripped off the bone.” By December, Beckett was bedridden and in constant pain. The slightest movement grated on her swollen joints and tore her damaged tendons. She couldn’t move from her bed or even sit up. Constant migraines added to her misery, vicious headaches coupled with nausea and dizziness that lasted for days. “She couldn’t even put a sentence together or communicate her needs, brush her teeth or feed herself,” said Hannah, Beckett’s daughter and caretaker. “She was in excruciating pain. Muscles were spasming, tendons and muscles were tearing spontaneously, (she had) severe migraine headaches 24/7, intense panic attacks. … This lasted intensely for the next 15 months.” They found a host of neurocognitive issues and heart damage as well as the tendonitis. As the tests went on, her vision faded until she was legally blind in her right eye. The left eye retained partial vision, but doctors say that will fade within a few months. She began to experience a feeling she described as waves of boiling water running up and down her body, a sensation of being constantly scalded. Muscle spasms turned into episodes of shaking and twitching, then morphed into seizures that landed her in the emergency room. Beckett began to have panic attacks and terrifying dreams, catapulting from her troubled sleep into a waking nightmare of shrieking joints, burning skin and tearing tendons. “There were months and months I basically screamed 24/7,” she said. “It was like a chainsaw peeling the skin and muscles off my feet and legs. It was unbearable, excruciating pain for the sheet to touch them, even the air to touch them. There was a period last October where my pastor came over. It was a very dark time. I said if I was a dog, you would put me down and call it humane,” Beckett said. “If I was a horse, you’d shoot me in the head and say it was mercy.”
https://www.youtube.com/watch?v=RZF_iWETXz0 Truth in Media Series, Ben Swann, June 8, 2016: The Revolving Door Between The FDA and Big Pharma. In this series, we’re going to take a look at Big Pharma, and its powerful influence over media, doctors, and even you. And we’re going to give you an unprecedented look at the truth behind the tactics, the strategy, and the revolving door between the FDA and the big Pharmaceutical companies that claim to be looking out for your health. It is a stunning accusation, the former commissioner of the FDA accused along with her husband of making hundreds of millions of dollars while suppressing information . . . about the dangerous drug Levaquin, whose deadly risks were concealed to protect financial interests . . . Brown’s annual income, not coincidentally, increased from a reported $10 million in 2008 to an estimated $125 million in 2011 . . . Levaquin was a blockbuster drug, and it was heavily prescribed by doctors. The FDA has been approving drugs, but once they’re on the market, there is very little oversight. Doug Bremner, physician, professor, and author at Emory University: “ . . . the number of people working on new drug approval has been increasing, at the expense of those who have been watching drugs after they come into the market.”. Laurie Powell, former Medical Brand Strategist: “The thing about the FDA is, the FDA is not a full time, career job. It’s a few years on the FDA, and then they’re being courted by the pharmaceutical companies . . . so the FDA person knows that their next jumping off point, to go from a lower paying government job (example $80K) to a very lucrative pharma job (example ($900K), they know that’s part of their career path, so I’m sure weighs heavily into their decision making process”.
http://www.wsoctv.com/news/local/some-worry-doctors-dont-know-about-new-warnings-on-some-antibiotics/326332295 WSOC-TV, Charlotte, NC, June 6, 2016: Some Worry Doctors Don’t Know About New Warnings On Some Antibiotics. Rachel said she only took Levaquin for seven days, but since then, she’s had tendons tear 10 times in 10 years. The FDA now believes they’re linked with serious side effects involving tendons, muscles, joints, and the central nervous system. It says the side effects outweigh the benefits for people with less serious infections, like sinus infections and bronchitis. Last month, the FDA ruled that the companies that make these drugs need to include stricter warnings with the medications. But Dr. Charles Bennett, with the South Carolina College of Pharmacy, said, “I’d say most doctors don’t know about this.” He wants the companies that make these drugs to send every doctor in the country what’s called a “Dear Doctor” letter, making them aware of the FDA’s ruling. “It says, ‘Dear Doctor, We want to inform you of important, new changes in the quinolones. Their risks outweigh their benefits for most diagnoses.”
http://www.nbc-2.com/story/32055596/nbc2-investigators-common-antibiotics-causing-painful-side-effects#.V0UWj2cUVy3 NBC2 TV News, Fort Meyers, Fl, May 24, 2016: Common antibiotics causing painful side effects. “You’d be amazed,” Laura said. “People in my life have no idea what I go through.” Laura was prescribed Levaquin and Cipro in 2011 to fight a stomach infection. The two drugs are part of the fluoroquinolone family. While the drugs beat back the stomach infection, the side effects were immediately clear to Laura (described and shown in our previous story). “It’s a full blown dystonic attack,” Laura said. “Twenty minutes of twisting and you know, painfully going through these horrible spasms.” At one point she had up to twenty of these attacks a day, some in front of her son. It’s why Laura was relieved when the Food and Drug Administration recently recognized the dangers of fluoroquinolones. In a statement, the FDA said: “The serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options.” The announcement came with requirements for warnings about the drug in the form of new labeling on the prescription and in medication guides. But at this point, it’s not clear how those changes will be reflected, according to Dr. Charlie Bennett. “Right now I can guess the company is negotiating with the FDA on the actual wording of the label change,” Dr. Bennett said. The changes are not enough according to Bennett, who filed a citizen’s petition to the FDA asking for more changes to the labeling. While the FDA recognized harmful side effects to tendons, muscles, joints and the central nervous system, Bennett wanted an additional explanation regarding the side effects related to mitochondrial toxicity. The FDA denied his request. “It’s a step but not a big step because we haven’t seen the label change, we haven’t seen the practice change. When you use a drug, how often do you use a drug, when the risks outweigh the benefits? ” said Bennet. Naples-based neurologist Dr. David Perlmutter fears over-prescription of fluoroquinolones will continue in the short term. “They are frankly, extremely dangerous drugs. But I still think we’re going to see significant overuse of the fluoroquinolones for the next several years.” He hopes doctors stop prescribing fluoroquinolones for non-serious infections and says they should only be used when no other options are left. “The notion of using these fluoroquinolones for a typical cold or sore throat or an ear infection is absolutely overkill,” Perlmutter said. It’s why Perlmutter and Laura are hoping that people listen to the stories of people suffering from fluoroquinolones. Laura says: “It’s tough every day. I thought, it was an antibiotic, it’s a medication, I’m going to recover from this, it might take a year, but I’m going to recover from this. But it’s been five years now. I’m hoping that doctors start seeing this and that we see less people joining these support groups because they have nowhere else to go because doctors don’t believe that this can happen.” But it’s possible her side effects might never go away.
http://kstp.com/news/patients-applaud-fda-warnings-popular-antibiotics/4145745/?cat=1 KSTP ABC5 TV News, Minneapolis-St. Paul, May 21, 2016: Patients Applaud FDA Warnings About Popular Antibiotics. He still has the pills. “Mine was a simple sinus infection”, says Bill, who was prescribed fluoroquinolones in 2015, around the same time we first reported on the serious side effects associated with the powerful and popular antibiotics. He says the drugs were prescribed to him only as a precaution and in conjunction with a steroid, a combination that has been known to cause severe tendon damage. Our story introduced Bill and many others to Jeannie, who suffered a severe adverse reaction. Bill thought: “Oh my goodness, I just took my third pill of that 10 minutes ago, I’m glad I’m not in that position.” But once his symptoms started, “I immediately knew I was in a whole new world,” he said. That world now includes a wheelchair. Bill still suffers spasms and numbness in his feet which makes it nearly impossible to walk. He stopped taking the medication after just three pills but says the damage was already done. This video, taken at the Mayo Clinic, shows the tremors and convulsions he feels in his body. Bill was forced to quit his career as a music teacher. “I think there are a lot of people out there who are in a world of hurt, and don’t even understand why they’re in a world of hurt. As the FDA warning says, they should be used as a last resort drug, not as a first drug.”
http://newjersey.news12.com/news/kane-in-your-corner-viewers-share-levaquin-stories-1.11820136 TV News12, New Jersey, May 19, 2016: Kane In Your Corner: Viewers share Levaquin stories. Thousands of New Jersey viewers reacting on social media after last night’s investigation into a popular antibiotic. “I can’t take care of anyone. They have to take care of me.” Lee was once an avid jet skier, who used to design costumes for movies. “You know I’m not 90 years old – but I can’t open jars. I can’t lift things up. There’s times when I can’t wash my hair, my poor husband has to do it.” Now she is so weak, and the tendons in her hands are so damaged, she may have to close her vintage clothing business. “I’m in bed most of the time. It’s hard for me”. Dr. Alan Lichtbroun, Rheumatologist: “We should not be giving these powerful drugs for simple sinus infections.” Last week, the FDA agreed. It issued a warning about using quinolones in routine cases, but only after getting 100,000 reports of serious side effects including tendon and nerve damage, and violent vomiting. Our story is drawing a massive response on social media.
http://newjersey.news12.com/news/kane-in-your-corner-did-fda-wait-too-long-to-warn-about-popular-antibiotic-levaquin-1.11814914#autoplay=true TV News12, New Jersey, May 18, 2016: Did FDA wait too long to warn about popular antibiotic Levaquin? Did the U.S. Food and Drug Administration drop the ball in warning doctors and patients about the dangers of a popular antibiotic? Last week, the FDA warned that Levaquin and other fluoroquinolone antibiotics carry side effects so great that the drugs should not be routinely prescribed unless no other treatment options exist. But Kane In Your Corner reports the government only took that action after more than 100,000 reports of severe side effects, and those who tried to sound the alarm say the feds waited much too long. More than anything, Janet Murray, of Piscataway, misses being able to make jewelry. Four years after taking Levaquin for a urinary tract infection, she suffers from severe nerve damage that makes it difficult to open and close her hands. She also says that “for months, I’ll sting all over my body. I can’t put clothes on.” S he describes the sensation as “like being electrocuted.” Lee Hoffman, of Bellmawr, first took Levaquin, known generically as levoflaxicin, for a sinus infection. Once an avid Jet-Skier who owns a vintage clothing store and designs costumes for motion pictures, she is now in too much pain to work. For years, both women say doctors wouldn’t believe them. “One doctor told me I should see a therapist because maybe it was anxiety or an emotional issue,” Hoffman says. They’re not alone. An FDA database shows patients who took Levaquin made over 100,000 complaints about a long list of serious side effects, including ruptured tendons, nerve damage, confusion and violent vomiting. At least 1,500 patients died while taking the medication. First approved by the FDA in 1996, it soon became one of the most prescribed medications in the United States. Doctors were “using it for literally everything,” says Dr. Derrick DeSilva, a doctor of internal medicine. “Whether you came in with a cold, whether you had an upper respiratory tract infection or an infection of your foot, it didn’t matter, we were using it indiscriminately.” But Levaquin is from a class of extremely strong antibiotics, the fluoroquinolones, which also includes the Anthrax/plague drug, Cipro. Last week, the FDA issued its strongest warning to date about fluoroquinolones, saying “the serious side effects…generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections.” “We should not be giving these powerful drugs for simple sinus infections,” says Dr. Alan Lichtbroun, a New Jersey rheumatologist. “With pneumonia, use the drug because you may not get a second chance.” Some say the FDA warning is too little, too late. “These side effects were sitting in the FDA’s adverse reporting system for decades,” says Dr. Charles Bennett, who runs a South Carolina pharmaceutical watchdog group. “And these patients have been asking physicians to help them for decades as well.” In fact, in 1997, just months after Levaquin hit the market, the FDA ordered a “black box” warning that it could cause tendon damage. And the FDA approved the drug despite its medical reviewers finding “significant flaws in protocol and design” of clinical trials. But some who’ve experienced side effects say the new warning isn’t enough. “What about the people who have already been poisoned?” asks Lee Hoffman. “How are you going to help them?” Meanwhile, Janet Murray says the hardest part of her side effects is the isolation, since her nerve damage and fatigue make it difficult to leave home. “I spend most of my time on the deck, talking to the birds and the animals,” she says. “It’s a very lonely life.”
http://www.wsbtv.com/video/local-video/fda-requires-new-labels-on-popular-antibiotic-after-channel-2-investigation_20160516204403/287400573 WSB-TV2 Atlanta, May 16, 2016: New FDA Warnings About A Drug That Put A Man In A Wheelchair. Our reporter talked to a local man crippled from the drug’s side effects. “I saw first hand what the drug Levofloxacin did to Jeff. It severely damaged his nervous system and put him in a wheelchair. He’d taken 7 pills prescribed for a sinus infection.” Jeff says, “A sinus infection, not even confirmed. And they break out something that’s designed for Anthrax? I have no idea who would come up with that”. The FDA is now warning doctors about Levofloxacin and its sister medications fluoroquinolones, saying they should no longer be prescribed for routine ailments such as sinus, bronchitis, or simple urinary tract infections, saying “the drugs’ disabling and potentially permanent and serious side effects” make the pills too risky when other options are available.
http://www.12news.com/news/be-warned-fda-issues-new-stronger-caution-about-risk-of-common-antibiotics/195586637 KPNX TV12 News, Arizona, May 15, 2016: FDA Issues New Stronger Caution About Risk of Common Antibiotics. The U.S. Food and Drug Administration has issued a new, stronger warning about the potentially disabling and permanent side effects associated with commonly prescribed antibiotics known as Fluoroquinolones. These antibiotics have been over prescribed and misunderstood for years in terms of their debilitating side effects.
http://www.newsnet5.com/news/local-news/investigations/fda-issues-major-drug-warning-for-popular-antibiotic-used-by-millions ABC5 TV News, Cleveland, May 13, 2016: FDA issues major drug warning for popular antibiotic used by millions. Last July, our investigation obtained an FDA database that revealed at least 3,000 patients whose death had been linked to the drug and another 200,000 complaints of side effects including kidney and nerve damage. As a result, the FDA now advises restricting the drugs for certain “uncomplicated infections” and is “warning about disabling side effects that can occur.”
http://www.abc15.com/news/national/fda-warns-of-potential-side-effects-of-powerful-antibiotics_39727435?autoplay=true KNXV ABC15 TV News, Phoenix, AZ, May 13, 2016: FDA: Common Antibiotics Side Effects Outweigh Benefit For Some Infections. One of the most popular antibiotics is now too risky to use for minor infections, and that has the FDA taking action. “The serious side effects generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections”. Experts say the move to increase warnings about the risks is long overdue.
http://www.abc2news.com/news/in-focus/fda-advises-use-of-cirpo-and-levaquin-be-restricted WMAR TV News, Baltimore, May 13, 2016: FDA Advises Use of Cipro and Levaquin Be Restricted. In an advisory Thursday, the FDA said the side effects generally outweigh the benefits for patients with things like sinusitis and bronchitis. Doctors are being told to “stop systemic” treatment immediately if a patient reports serious side effects.
http://www.fox13memphis.com/news/the-one-word-you-must-know-before-going-to-the-doctor/280917168 FOX13 News, Memphis, TN, May 13, 2016: The one word you must know before going to the doctor. Experts say they are drastically overprescribed, and the next time you see your physician, you should know the word “fluoroquinolone”. The FDA has now made it clear. There is no reason for physicians and patients to not know about the warnings surrounding fluoroquinolones. The FDA went on to say these drugs are associated with disabling and potentially permanent, serious side effects.
http://www.wsoctv.com/news/local/fda-adds-warning-labels-to-popular-antibiotics/279438583 WSOC TV, Charlotte, NC, May 13, 2016: FDA changes warning label on popular antibiotics. An FDA safety review found the anti-bacterial drugs are associated with “disabling and potentially permanent, serious side effects.” The FDA acknowledging this is really a big step. The FDA said in an email these drugs should be reserved for people who don’t have alternative treatment options.
http://www.theindychannel.com/news/call-6-investigators/fda-announces-antibiotic-label-changes-following-call-6-report RTV6 ABC, Indianapolis, May 13, 2016: FDA announces antibiotic label changes following Call 6 report. FDA is making big changes following a Call6 investigation and enormous public outcry . . . these drugs have serious side effects, side effects which generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections who have other treatment options. Patients with those conditions should only use fluoroquinolones as a last resort, according to the FDA. This decision is huge, and the announcement comes after years of public testimony and outcry about the drug’s disabling, permanent, and deadly effects . . . While more work needs to be done the FDA’s changes give weight to the testimony of all those suffering from fluoroquinolone toxicity and sends a clear message to doctors that these drugs must be used sparingly, only when necessary and that physicians must take seriously patient complaints.
http://www.abcactionnews.com/money/consumer/taking-action-for-you/fda-announces-warnings-for-most-commonly-prescribed-antibiotics-levaquin-and-cipro WFTS News, Tampa Bay, FL, May 13, 2016: FDA Announces Warnings For Most Commonly Prescribed Antibiotics – Levaquin and Cipro. Ten years ago Laura suffered devastating side effects after taking Cipro for a common urinary tract infection. Severe nerve damage forced her to live with chronic pain and robbed her of the ability to work and travel. “There were many days when I couldn’t go in because it was so painful and I sat at home and wrapped myself up in an electric blanket, and cried, frankly. My condition has gotten progressively worse”. With these new warnings, The FDA is asking doctors not to prescribe fluoroquinolones for common infections.
http://wric.com/2016/05/12/fda-label-changes-for-fluoroquinolones-to-include-warnings-of-serious-side-effects/ ABC8 News, Richmond, VA, May 12, 2016: FDA Issues New Label Changes For Common Antibiotics. In a major shift today, the FDA now says that the serious side effects associated with fluoroquinolones generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections who have other treatment options. According to the FDA, a safety review has shown that fluoroquinolones are associated with disabling and potentially permanent, serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.
http://www.tmj4.com/news/i-team/i-team-investigation-antibiotic-side-effects-that-could-damage-your-health WTMJ-TV, Milwaukee, WI, April 28, 2016: Antibiotic Side Effects That Could Damage Your Health. Three years ago Kelly was prescribed Cipro for a bacterial infection. In August of 2013, the FDA issued a warning about permanent nerve damage as a possible side effect of fluoroquinolones. But that was months after Kelly took Cipro. “I literally couldn’t use my body,” she said. Kelly says she reacted to the first pill. Then came joint pain. On the fifth day, Kelly says her symptoms got scary. “I woke up in the middle of the night with an electric shock like feeling in my body. Pain that I can’t even describe to you how bad it was.” ended up in the emergency room. Doctors were stumped. She couldn’t walk, and with her symptoms getting worse, Kelly was referred to a doctor at the Mayo Clinic in Minnesota. “He believed it was a reaction to the antibiotic. There was nothing to do for it. The nerve damage and all of that was already done.” Over the years, reports have flooded into the FDA . Patients complain of similar side effects like pain, muscle weakness, tendon rupture. All of them took an antibiotic in the fluoroquinolone or “FQ” family. Kelly and her husband say life is completely different these days. She still lives with constant exhaustion and pain, and there are many things she can’t do. “No bike rides, no hiking. I can’t grocery shop alone. I can’t handle pushing the cart.” Kelly still hopes she’ll recover fully, but there’s no research to tell her what to expect. “I might just have to get used to this being what life is going to be like.”
http://www.theindychannel.com/news/call-6-investigators/call-6-mother-blames-antibiotic-for-sons-death RTV6 ABC TV News, Indianapolis, April 25, 2016: Mother blames antibiotic for son’s death. Purdue University student took Levaquin. Tonight, an Indiana mother’s heartbreaking story of loss. After his freshman year at Purdue, Heather’s son Shea decided to have surgery for a deviated septum. His doctor prescribed 30 days of a powerful antibiotic known as Levaquin. “He didn’t even have an infection. This was just to prevent an infection from happening. It’s like taking a cannon to kill a mosquito.” He started acting strangely, and said he told doctors, friends, and family that he felt the drug was messing with his mind. So he quit taking it, but Heather says, the effects still lingered. “He went back to campus and the first thing that started happening was he kind of started having these, like, anxiety attacks, and heart palpitations.” He had never had anxiety up till then. His anxiety got so bad he dropped out of school and ended up in the mental health system, where doctors gave him more medication after diagnosing him with bipolar disorder. Heather says: “He was a faint shadow of who he was.” On October 23, 2013, Shea jumped out of a second story window, got in his car, and crashed into an embankment. He died at the age of just 24. The FDA database of adverse reactions to Levaquin has more than 31,000 complaints since 2010, including 179 reported deaths. Heather testified in November 2015 before an FDA advisory panel convened to talk about fluoroquinolones. “This was a drug-induced death that was unnecessary,” she told the panel. She said it was shocking to hear similar stories of people impacted by the powerful antibiotics. “People don’t make this stuff up,” she said. “This drug has had a horrific impact on lives.” Consumer advocacy group Public Citizen also testified at the hearing. “Too often, these drugs are prescribed for illnesses that don’t require an antibiotic,” said Michael Carome, director of Public Citizen’s health research group. “The FDA should consider making labeling changes and we hope they will do that sooner rather than later to protect public health. It shouldn’t take that long to get important labels on drugs.” Heather says, “The hardest part about this is that my son knew what was wrong with him, and no one listened to him”.
http://www.local10.com/video/popular-antibiotic-linked-to-adverse-reactions WPLG 10 News, Miami, FL, March 10, 2016: Popular antibiotic linked to adverse reactions. Chana says: “I was very active, I ran 5 miles a couple of times a week, I used to do Zumba with my daughter, and I have 5 children, so I was a very active mother”. But that was before she was prescribed Ciprofloxacin to treat bronchitis, a popular antibiotic linked to something called “Fluoroquinolone Toxicity”. Today this once healthy mother often struggles to stand up long enough to cook dinner. She has had several tendons spontaneously rupture. She often feels a crushing burning pain throughout her body. “And it’s hard, you know, I can’t go for a bike ride with them, or go roller skating, there are a lot of things I’d like to do, and I just can’t do them”. Lola says: “I couldn’t walk at all, I’d crawl, and that lasted probably for about 3 or 4 weeks. If I can spare somebody this horrible thing happening to them, then I should do it, as a human being”. Dr. Charles Bennet, Drug Safety Specialist at the University of South Carolina, who’s been studying these adverse reactions for years: “They can’t concentrate, they can’t see the computer screen, they can’t think, they have a lot of pain, sometimes tendon pain as well . . . we need to have every physician, every patient, every pharmacist, and every nurse, know that when the patient takes the drug, this might occur.” Same FB page story with comments here.
http://www.fox2detroit.com/news/local-news/94184293-story FOX2 News, Detroit, MI, February 19, 2016: Monroe woman who suffered Levaquin side effects ‘wanted to die’. She’s been in pain every day since taking the antibiotic Levaquin in 2009. Since taking the drug, her relationship crumbled, she became too ill to work and she lost her home. “I felt like I was going crazy, and I wanted to die, and I told my family, I just want to die, I want to die. How could you do that to people? How could you live, on the deaths of others, and sleep at night? I knew that I was poisoned, but I couldn’t prove it”. Attorney Larry Klayman says that Levaquin, which is still being distributed, is estimated to have killed nearly 5000 people, and injured roughly 80,000 people. “It’s not just a question of compensating the victims, but of protecting people throughout this country and the world. People have died, some of them can’t even swallow, it has all kinds of side effects”. But Klayman says he’s confident there are thousands of more people out there and is asking for more than $800 million for these victims.
http://www.qmed.com/mpmn/medtechpulse/why-lightning-rod-lawyer-smells-rat-fda Qmed article (not a video), February 12, 2016: Why a Lightning Rod Lawyer Smells a Rat at FDA. “You hold $500 million of shares in a company, and your husband is profiting from that in terms of Renaissance, and you don’t do anything about a very dangerous drug, and you walk off . . . This is a conflict of interest, however which way you call it. You should not be an FDA commissioner if you have that type of conflict, or you should take yourself off of any aspects of regulating Johnson & Johnson. Instead of doing that, she put Johnson & Johnson people on advisory committees. That’s another thing to look into . . . You don’t let people run the FDA who are politically or economically conflicted. And if they want to be FDA commissioner, you put in a rule that they can’t go into private industry for five years or something to that effect, kind of like the lobbying regulations out of the White House . . . If you want to be FDA commissioner, you have to be clean in terms of conflict of interest, and you can’t take a job in the pharmaceutical industry or as a consultant or contractor for at least five years.”
http://wric.com/2016/02/07/federal-lawsuit-filed-against-former-fda-commissioner/ WRIC ABC8 News, Richmond, VA, February 7, 2016: Federal lawsuit filed against former FDA Commissioner. “A federal lawsuit has been filed alleging the former FDA Commissioner who was well aware of problems with a popular antibiotic, but remained silent so she could profit. It alleges that the former FDA Commissioner, Dr. Margaret Hamburg, defrauded consumers and conspired with Johnson and Johnson, the makers of the drug, to suppress information about the harmful effects of Levaquin for financial gain. “Dr. Hamburg had a very big conflict of interest when she was FDA Commissioner,” says Klayman. Meanwhile, the fight to warn others about the potential dangers from Levaquin and similar drugs Cipro and Avelox is moving to Capitol Hill.”
http://www.wsbtv.com/news/news/local/channel-2-investigates-levaquin-dangerous-side-eff/nqG83/ WSB TV2 Atlanta, February 1, 2016: Channel 2 investigates Levaquin dangerous side effects. “Victims of the same controversial medicine blamed for a Gwinnett County man’s death are suing the former head of the Food and Drug Administration. “The head of the FDA owning, either directly or indirectly, substantial stock in that drug company? The conflict is insurmountable,” said Decatur pharmaceutical watchdog attorney Roger Orlando. A suit filed by Los Angeles attorney Larry Klayman, a graduate of Emory Law School, claims at one point during Hamburg’s tenure, her husband’s hedge fund held $500 million dollars in J & J stock. “It sounds like now there’s so many questions and it sounds like she was in it for the money, not so much the welfare of people, if this is true,” said Kathy Dannelly of Gwinnett County. Dannelly’s husband, Chris, died three years ago after only three pills of Levaquin generic. She wonders now whether Hamburg did as the suit alleges: “…actively concealed . . . the true risks of the drug.” “He wouldn’t have been given this medicine, and it wouldn’t have had this disgusting, sad outcome,” she said.”
http://www.abc2news.com/news/in-focus/johnson-johnson-former-fda-commissioner-among-defendants-in-levaquin-lawsuit WMAR, ABC2 TV, Baltimore, January 22, 2016. Johnson & Johnson, former FDA commissioner among defendants in Levaquin lawsuit. “The lawsuit is unusual because the plaintiffs are alleging that the company engaged in racketeering and violated the Federal RICO act—a law normally used to prosecute organized crime. Levaquin and other fluoroquinolone drugs were the subject of an FDA hearing in November. Two FDA committees overwhelmingly voted that the existing labels do not fully explain the risks of taking the drugs.” Read comments after story to see what victims are suffering from. Read accompanying article: “Levaquin users slap J&J with $800M RICO suit, claiming pharma giant hid serious side effects”.
https://www.facebook.com/abc2infocus/videos/1198237746857863/ WMAR, ABC2 TV, Baltimore, November 24, 2015. Overprescribed Antibiotics?. In a recent FDA meeting, experts identified a new batch of side effects which include muscle, connective tissue, nerve damage, psychiatric episodes, loss of hearing or vision, and that’s just to name a few. Attorney Daniel Miller said: “Many of these people were never able to go back to work again, for instance. I had several times where people said they were seriously contemplating suicide because the quality of their life was so bad.”
http://www.abc2news.com/news/in-focus/overprescription-of-antibiotics-creating-resistance-while-patients-endure-unnecessary-side-effects WMAR ABC2 TV, Baltimore, November 24, 2015: Overprescription of antibiotics creating resistance, while patients endure unnecessary side effects. Baltimore attorney and advocate Daniel Miller is different from everyone else who spoke up at an FDA meeting this month: “These drugs are overused, overprescribed, and over marketed.” He hasn’t been personally harmed by fluoroquinolones, known under brand names like Levaquin and Cipro. But he knows many people who have been. “I got involved with some grassroots organizations, got to know a lot of people over the years and heard hundreds of stories of people who not just had tendon rupture, but who had all these other cluster of debilitating side-effects,” Miller said. The FDA is debating changing the labels on these powerful antibiotics. Specifically at issue is whether fluoroquinolones should continue to be approved for sinus infections, bronchitis and urinary tract infections. Miller likened the drugs to using an A-bomb to kill a housefly. “People are being hurt everyday and it’s so tragic because it’s unnecessary,” he said. “There are other treatments that can be used and people are being badly injured for no good reason.” Dr. John Powers, associate clinical professor at George Washington School of Medicine, agrees. He’s a leading expert on antimicrobial drugs and a clinical researcher. Powers said quinolones are effective against certain life-threatening conditions, but existing studies show that the drugs do not perform any better than placebos in treating minor infections, like sinusitis. “We’re giving people excess side effects, when they don’t need them to begin with, for self-resolving illnesses,” he said. “Secondly, by spreading antibiotic resistance, we’re eliminating the benefits of these drugs for the sickest people who do need them.” Miller said federal law does little to protect people who are hurt by a pharmaceutical drug. On top of the crippling side effects, the majority of people who have been harmed by these drugs,have no recourse under the law. The overwhelming majority of people take generic fluoroquinolones. A 2011 Supreme Court decision ruled that a patient harmed by a generic drug cannot sue its manufacturer, because generic drug companies are required to use the exact same label as the brand-name version. “People who are hurt by generic drugs have no rights, whereas if your prescription was filled with a brand-name drug, you would,” he said. “Due to that anomaly, many people have no ability to bring about a case.” Advocates support updating the warning labels on fluoroquinolones to include additional severe side effects linked to the drugs. Dr. Powers said that still isn’t enough. Even if labels are changed, doctors don’t read them and patients don’t see them. “There needs to be something that goes beyond just labeling, in terms of education of both clinicians and of patients,” he said. “This goes beyond just for quinolone antibiotics. It’s a bigger issue in general of educating clinicians and patients about the appropriate use of antibiotics.” The FDA is seriously considering a rule change that would allow generic drug manufacturers to update their own product labels, when a safety issue is identified. Now, they have to wait for the FDA to approve a label change. Generic drug manufacturers are very much against this change, as it could open them up to failure to warn lawsuits.
The following eight group of news clips are the coverage of the November 5, 2015 FDA Antimicrobial Drugs Advisory Committee and FDA Drug Safety and Risk Management Advisory Committee hearing. The committee voted overwhelmingly that better warnings are needed on all fluoroquinolone antibiotics to warn physicians and consumers of the potential for the severe constellation of symptoms which they are now calling “Fluoroquinolone Associated Disability” (FQAD). “FDA reviewers raised concerns about a “constellation of symptoms” that are being called Fluoroquinolone- Associated Disability, or FQAD. We find an association between oral fluoroquinolone use in previously healthy U.S. patients being treated for uncomplicated cases of sinusitis, bronchitis, or UTI, and the development of FQAD.”
FDA holds meeting to discuss Levaquin, other fluoroquinolone side effects. WMAR – ABC2TV, Baltimore, November 5, 2015
Families To Share Horror Stories With FDA. WBZ-CBS TV News, Boston, MA , November 5, 2015. Oliver Newell’s suicide due to taking Cipro is discussed in this story; also more details by the Newell Family here.
Committee recommends label changes, warnings for popular antibiotics like Cipro, Levaquin. KNXV-ABC15TV, AZ, November 5, 2015
Patients share horror stories from commonly used antibiotics. WRIC-ABC8 TV, Washington DC, November 6, 2015. “I immediately lost the use of my legs, whole body burning,” said Kaplan. “Within days of starting Levaquin I completely lost control of my bladder. I had blood clots and spontaneous tendon ruptures,” said Girard. “I have been severely injured since 2006,” King explained.
FDA Panel Seeks Tougher Antibiotic Labels: Mounting evidence of previously unknown, and sometimes permanent, side effects prompted review. Not a video, this is from the Wall Street Journal, November 5, 2015. “Nine pills took my health away. I suffered excruciating pain over a year.” Since then, Ms. Siani, director of a social-services program, said she walks with crutches. Panel member Dr. Tobias Gerhard, professor in the Department of Pharmacy Practice at Rutgers University, said the panel voted for the stronger label warnings “because of the remarkable testimony that we have heard today.” “Over the life-cycle of these drugs, several adverse reactions have been reported and most of them were not evident in the preapproval safety databases,” the FDA reviewers wrote.
FDA advisory panel hears from Georgia woman about Levaquin. WSB-TV2, Atlanta, November 5, 2015. “There was no informed consent,” said Delaine. One man read the suicide note of his brother, who said he killed himself rather than battle the side effects.
Webcast (Long): Here is the recorded footage from the Center for Drug Evaluation and Research (CDER) webcast of the November 5, 2015, joint meeting of the Antimicrobial Drugs Advisory Committee and the Drug Safety & Risk Management Advisory Committee regarding fluoroquinolone antibiotics. Start of meeting to morning break, Morning Break to Lunch Break, Lunch Break to Afternoon Break (Open Public Hearing Speakers including flox victims can be found in this section), Afternoon Break to End of Meeting.
Articles about the FDA hearing: Tech Times: Fluoroquinolones Need Stronger Warnings About Side Effect Risks, Says FDA Panel, MedScape: FDA Panel Says Fluoroquinolones Need Stronger Warnings,
http://boston.cbslocal.com/2015/11/04/mass-families-testify-fda-fluoroquinolones/#.VjselbUR6I4.facebook WBZ-TV CBS Boston News, November 4, 2015: Nick Newell will tell federal regulators how his brother Ollie started a downward spiral after taking several doses of Ciprofloxacin. It was prescribed for a urinary tract infection. Ollie was a vibrant robust man who still played basketball, but his body couldn’t withstand the impact of a fluoroquinolone. He took his own life after his symptoms continued to worsen. In a letter to family and friends, Ollie wrote “I guess this affliction beat me. . . I did try pretty hard to get past it, for what it is worth. Sort of tough to do with all systems affected (muscles, joints, skin, nerves, heart, intestinal, memory, hearing, etc. . .) and really no end in sight.” Nick will read Ollie’s letter as part of his testimony. “We saw this drug completely change him.” Liz Newell, Ollie’s sister, said he was troubled by the deep mental fog brought on by the drug. Thousands of patients have reported crushing side effects like ruptured tendons, nerve damage, and psychological impairment. That’s what happened to Andrea of Concord when she was treated with Levaquin for a non-life threatening infection. Today, Andrea is able to get around her home without crutches, most of the time. That is a big improvement from when we first met her last winter and she needed them all the time. “I still have a huge problem walking. I can walk around the block. That is about the limit of my walking.” The community health worker plans to tell the FDA just how healthy she was before she took the truck. In fact, she went skiing on Tuckerman’s Ravine just a few days before taking her first dose.
http://www.myfoxmemphis.com/story/30434226/fox13-investigates-powerful-drug-you-need-to-know-about WHBQ FOX13 Memphis TN, November 4, 2015: Before you go to the doctor again, you’re going to want to see this next story. Experts say they are drastically over prescribed and carry potential side effects that some say may ruin lives. Aaron took Levaquin for one week back in 2014 to treat a urinary tract infection. Today, this once active husband in his thirties, whose life was consumed with crossfit competitions, experiences insomnia, joint pain and has a hard time doing everyday activities. And he can’t move without feeling chronic joint pain all over his body. “A lot of times I’m sidelined from just basic life activity. Sometimes I struggle just to cut the grass, so that’s my new reality. I’d lay in bed at night, it was just like, something was dissolving me from inside. I live a shell of kind of a life I used to know. Here I am 18 months later, almost daily or weekly there’s some new effect manifesting. I don’t know if it will ever stop. Will these things ever heal? Is it only going to get worse?” Dr. Michael Gelfand is an infectious disease professor at the University of Tennessee. Dr. Gelfand said many prescribing doctors aren’t aware of any of this. “Every physician probably doesn’t spend a lot of time looking at the boxes and the prescribing information,” Gelfand told FOX13. A new report, set to be released Thursday, will classify many of those patients with fluoroquinolone-associated disability (FQAD).
http://www.wsbtv.com/news/news/local/gwinnett-woman-testify-fda-panel-about-controversi/npGSz/ WSB-TV Atlanta, November 4, 2015: A woman from Peachtree Corners plans to testify at the FDA hearing Thursday in Washington, D.C. “I was poisoned. That’s how I feel. There’s no other word to describe what happened to me other than poisoning,” said Nicole Delaine. Delaine, formerly an avid runner, found in April 2014 that she could not walk. A pharmacy clinic prescribed Levofloxacin for a sinus infection. Delaine said she took only three pills. The FDA has dubbed the series of side effects FQAD, or fluoroquinolone-associated disability. “Prescribers are not paying attention to these warnings. My tendons in my ankles, were just hit so hard, that I couldn’t walk. Using a fluoroquinolone for a sinus infection is like using an atomic bomb to kill a fly,” Delaine said.
http://wric.com/2015/11/04/fda-to-hear-patient-complaints-about-commonly-prescribed-antibiotics/ ABC8-TV, Richmond VA, November 4, 2015: They’ve been called a ‘Prescription for Pain’. “I’m starting to lose my short term memory” Rachel says. She suffers from neurological damage, and physical scars. Thursday, Rachel will get to tell the FDA, in a rare hearing, that she believes one dose of Levaquin, an antibiotic she was given to treat a sinus infection back in 2006, has left her with permanent pain. “This was a tendon rupture in my wrist. Within a month of taking Levaquin I ruptured my first tendon, it was my Achilles’ tendon, and in the last nine years, I have ruptured 10 tendons.” Since then, 8News found that she’s not the only one reporting tendon ruptures, nerve damage, and neurological problems. An 8News Investigation has found an FDA database now reports 3,000 deaths and more than 200,000 complaints related to the drugs.
http://www.abc15.com/news/local-news/investigations/fda-announces-meeting-to-discuss-safety-of-popular-antibiotics-like-cipro-levaquin ABC 15-KNXV Phoenix News, Oct 27, 2015: FDA announces meeting to discuss safety of popular antibiotics like Cipro, Levaquin. In a briefing about the meeting , FDA reviewers raised concerns about a “constellation of symptoms” that are being called Fluoroquinolone- Associated Disability, or FQAD. People who may have FQAD were described in the report as: • Patients who were previously healthy • Patients who took a fluoroquinolone to treat a urinary tract infections, bronchitis, or sinusitis • Patients who experiences adverse events in two or more body systems, including peripheral neuropathy, neuropsychiatric, musculoskeletal, senses, cardiovascular, and skin. • Patients who had a substantial disruption of their normal life functions. On page 28 of the briefing, reviewers concluded: “We find an association between oral fluoroquinolone use in previously healthy U.S. patients being treated for uncomplicated cases of sinusitis, bronchitis, or UTI, and the development of FQAD. While the individual components are included in fluoroquinolone labels, a description of the constellation of disabling adverse events is not currently described in the fluoroquinolone labels.”
http://www.abc2news.com/news/in-focus/advocates-push-fda-for-added-warning-label-for-levaquin-side-effect ABC2-WMAR TV Baltimore News, September 16, 2015: Terry’s life is completely different than it used to be. “It’s destroyed my life. It has shattered my life. I don’t have a life. I’m existing now. I’m tired all the time. I have to really push to get anything done. I have pain every day, all day, throughout my body. I had lost all my neck muscles, and my neck would keep dropping. I would have no control over my neck, and I was having a very difficult time walking. These are serious drugs, with serious side effects.” Dee, who experienced crippling side effects after taking the antibiotic for 3 days for a UTI, says: “We want doctors to stop handing out these medications like candy. We want patients to be warned. There was one hour I walked outside healthy, and then it was like a bomb went off in my body. It was like every cell was changed in my body, you could feel that something really happened. Connective tissue damage, problems to my central nervous system, problems to my nerves, my eyesight comes and goes sometimes, I sometimes have numbness to my face and lips. I live with some pain every day.” Dr. Charles Bennett, who chairs the Medication Safety and Efficacy Center of Economic Excellence at the University of South Carolina, says: “We want a Black Box Warning, to make it clear, the side effects of the drug are this, if patients get sick, they understand what is happening. Patients, also ask your doctors up front: Do I really need this medication? Cipro and Levaquin are two of the most commonly over prescribed medications we have. They’re very strong, no doubt about it, but they can have tremendous side effects that can really affect patients for a long time.”
http://www.theindychannel.com/news/call-6-investigators/call-6-investigates-patients-raise-concerns-about-powerful-antibiotics ABC6-WRTV Indianapolis News, August 27, 2015: Travis says his body was never the same after taking the drugs, which caused his nerve damage: “It hurts to breathe. My skin burns like I’ve been in a fire and taken back out. It’s difficult to lay down, to sit up, and it’s continuing to get more and more difficult to walk. There’s too many cases, and the facts are too substantial to be ignored for very much longer.” Nancy says: “My body just seemed to completely slow down, it was like I could barely walk.” For some, it’s already too late. Bob’s wife struggled with painful tendons and joints for years after taking Levaquin. Her husband says the pain became so bad, she took her own life. We found 3000 reportedly died, and another 200,000 complaints. In 2008 the FDA issued a Black Box Warning of an increased risk of ruptured tendons, and in 2013 the FDA expanded the warnings to include serious nerve damage. Another FDA report linked the drugs to possible cell damage known as mitochondrial damage.
http://www.10news.com/news/levaquin-fda-fails-to-disclose-additional-serious-side-effects-of-antibiotic-linked-to-deaths-072815 ABC 10 KGTV San Diego TV News, August 10, 2015 Update: Despite being linked to death and other serious side effects, we found the FDA knows more than its telling. Patients say: “I took it for a couple days, by the third day, when I woke up, I couldn’t see. I was having such horrible, horrible joint pain, my knee was killing me, I was hobbling”. “This [drug]should be a last resort, not a first line of defense”. “You go to bed thinking, what’s wrong with me, am I going to die, and who is going to provide for my family”. “I should have been told, OK, you can have permanent damage.” We obtained an FDA database of adverse effects and found at least 3000 reportedly died, and another 200,000 complaints related to Levaquin and other fluoroquinolones.
http://www.abcactionnews.com/money/consumer/taking-action-for-you/popular-and-powerful-antibiotic-label-fails-to-list-all-of-the-severe-side-effects ABC-WFTS Tampa Bay News, August 3, 2015: Tens of thousands of patients across the country report devastating side effects and in some cases, death. Jody says: “Now it’s real bad. Sometimes the pain is just so intense, I can’t even walk sometimes.” In 2013 the FDA expanded the Black Box Warning, its most serious, to include both ruptured tendons and nerve damage suffered by many. Nancy says: “Anything tight will make my feet ice cold. My body seemed to just completely slow down, it was like I could barely walk.”
http://www.kjrh.com/news/local-news/man-warns-those-considering-levaquin-of-dangerous-possible-side-effects KJRH 2 News, Tulsa, OK, July 28, 2015: For 4 years Parker’s arms have not stopped shaking. “The only time the tremor ever slows down, is when I go to sleep, and I have to take medication to make myself go to sleep.” Parker’s tremors stem from nerve damage that his doctor says was caused by taking Levaquin. A different doctor prescribed the antibiotics to Parker, without warning him of the possible side effects. “It’s very heartbreaking and frustrating even to this day,” said his wife, Tonya. “I have no control over this, and I’ve dealt with this ever since.” Parker has a message to share for those considering taking the drug. “Pain all over. Avoid it, because you don’t want to end up four years later like I have.”
http://www.newsnet5.com/news/local-news/investigations/levaquin-fda-fails-to-disclose-additional-serious-side-effects-of-antibiotic-linked-to-deaths ABC-5 News, Cleveland, July 27, 2015: Cindy was being treated for a sinus infection: “It ruined my eyes, really, I woke up, took it for a couple days, by the third day, I couldn’t see. Beyond that, I was having such horrible horrible joint pain, my knee was killing me, I was hobbling.” She finally stopped taking it, and we found she is far from alone. Bob’s wife was never warned, and took Levaquin and it resulted in so much pain that his wife was forced to use knee pads and a wooden board on rollers to move around. “Nobody told us anything about the side effects. The side effects of Levaquin were such that she could not walk, it attacked the tendons in her ankles, her wrists, she ended up wearing wrist braces, her wrists hurt, her ankles hurt . . . It was just an accumulation of the various pains from that and other health conditions that pushed her over the edge.” After years of struggling with pain, she committed suicide. Despite the drugs being linked to death and other serious side effects, we found the FDA knows more than it’s telling. This FDA database shows at least 3000 reported deaths, and another 200,000 complaints related to fluoroquinolones. Dr. Charles Bennet says: “The FDA gets about 1% of all reports. Take 3000, multiply that by 100, we’re talking about 300,000 deaths. That’s a lot.” There are other possible side effects the FDA is aware of, but remaining silent. We obtained this FDA report, and it raises alarming questions about possible Mitochondrial Toxicity in addition to the other existing Black Box Warnings for the drugs. Dr. Bennet says: “All we’ve asked for is very simple: please put the FDA’s own findings and information where doctors can find it in a Black Box Warning on the back of the inserts”. Instead, the FDA wrote back claiming it’s been unable to reach a decision.
http://kstp.com/news/stories/s3823890.shtml KSTP-ABC News, Minneapolis/St. Paul, June 11, 2015: It’s a drug so powerful, it’s used to counteract Anthrax, but some doctors say it’s causing as much harm as good. We first told you about fluoroquinolones in February. A woman from Princeton says she suffered hallucinations and severe pain in her tendons after taking just four pills of Levaquin, a popular type of this antibiotic. We soon learned, she is not alone. Shortly after we aired that story, patients and doctors emailed me about their concerns about fluoroquinolones and why they want the FDA to warn others. “I had severe side effects. My tendons were feeling so tight and extremely painful, like they could rip at any moment. I suffer every day.” These are some of the emails after I first reported on the side effects of fluoroquinolones, a popular and powerful type of antibiotic. Michelle, an athletic 29-year-old school teacher before she started taking Cipro, now feels severe pain in her tendons and struggles to walk up the stairs. “This was unnecessary. It was a machine gun prescribed to kill a mosquito. I had absolutely no idea it could cause permanent damage. I’m very limited in what I can do.” “Knowing what you know now about fluoroquinolones, do you think there are enough warnings out there?” “Absolutely not”, she says. “Many doctors are not aware of how dangerous these medications are.” “The current risk is that the physicians are undereducated and under informed,” Dr. Charles Bennett said. It can lead to nerve damage and has been associated with neurodegenerative diseases like Parkinson’s and Alzheimers.
http://wric.com/2015/06/01/fda-researchers-looking-into-prescription-drug-after-complaints-8news-investigation/ WRIC-ABC News, Richmond, VA, June 1, 2015: Some commonly prescribed antibiotics are now getting some new attention from the FDA and medical researchers. Many of you have reached out with concerns about the medications, telling us these drugs have caused permanent damage. There is a sign the FDA may be listening and considering action regarding these drugs . . . Melvin questions the FDA: “Why haven’t you guys done something with your own data? Your own people recommended stronger warnings, and that was the premise of going back to them and showing them that they were legally obligated to protect the public”. We have also learned UC San Diego’s medical school is now conducting study on effects of these drugs and is looking for people to participate.
http://wric.com/2015/05/20/8news-investigates-doctors-left-in-dark-about-prescription-drug-dangers/ WRIC-ABC Richmond, VA, May 20, 2015: 8News viewers are coming to us, saying they’ve had devastating side effects from popular antibiotics. We have been flooded with calls, emails and Facebook messages. Our original story reached about 70,000 people on Facebook. When it comes to the warnings, doctors are often in the dark. Robin says: “My life stopped that day. It’s terrible. I have a granddaughter I want to lift so bad, I can’t even lift her. I get so angry sometimes. It’s just not fair. I have a constant burning, if you can think of the worst sunburn you ever had, that’s what my body feels like, and it doesn’t go away.” She hasn’t been able to work a day since she was prescribed Levofloxacin. She took just five pills and says, she’s never been the same. “I went to stand up, and I couldn’t stand up. And the pain in my legs, in my knees, is where it first started; it just felt like someone was ripping my knee caps off.” “I’ve lost my wife” says Dave. Others say: “I have trouble with fine motor things, like tying my shoes”, and “I found that I have problems, doing ordinary things, like carrying on conversations.” Dr. Charles Bennett says: “I think most doctors are in the dark. Many doctors will not even know there’s a Black Box with the [generic] product because the original product didn’t have a Black Box. We got a report back from the FDA saying that they have received the petitions, the petitions raise good questions, and they’re going to review them.” Robin says, “Question what you take. Ask questions, that’s what a lot of us have learned the hard way.”
http://www.abcactionnews.com/money/consumer/taking-action-for-you/powerful-and-popular-antibiotic-sometimes-comes-with-out-warning?autoplay=true ABC News, Tampa, FL, May 12, 2015, Follow Up Story: A black box warning means just that – a black box should outline the most severe side effects. These warnings are mandated by the FDA. But we found those black boxes aren’t meant for the patient, only the doctor. Jodi says no one warned her the powerful antibiotic can cause devastating side effects including severe tendon pain and nerve damage. “Sometimes the pain is so intense, I can’t walk, my ankles, my legs. Now it’s real bad. I started noticing a direct downfall after my second round of Levaquin for a sinus infection.” Jodi says no one warned her the powerful antibiotic can cause devastating side effects, including tendon pain and nerve damage. “I don’t recall [seeing warnings] on my bottle, to be quite honest with you. Not one word on that bottle that would tell me what I am feeling right now. This should not be happening to me or anybody else.” Shirley said she’s experienced extreme pain in her hand and arm since taking Levofloxacin for a urinary tract infection in March. The warnings for severe side effects are buried in the fine print on page three. She wonders why the labeling information that goes to the doctor contains a black box but what’s distributed to the patients does not. The pain was so great the 88-year-old ended up in the emergency room. “It hurts when I sit down or get up. I had a tingling in my hand and pain all the way up my arm. They just gave me all those tests and sent me home, and I’ve been in constant pain since. I think it should be a “Red Box” warning.” (My note: Patients over age 60 are considered part of the “at risk” population, and should not be prescribed FQ’s as a first choice antibiotic for a simple UTI).
http://sanfrancisco.cbslocal.com/2015/05/06/like-a-bomb-went-off-in-my-body-patients-demand-new-antibiotics-warnings-due-to-strong-reaction/ KPIX-CBS San Francisco, May 6, 2015. The reports of pain and suffering are popping up everywhere. Patients say: “It felt like flames were coming out of my elbows”. “After the first pill I noticed that I wasn’t able to follow conversations with coworkers.” “It felt like a bomb went off in my body.” “It’s the only medication I was on.” “People’s lives are being destroyed by these drugs, and it’s not OK.” “They haven’t done a good enough job warning the public about how dangerous this drug is.” Dr. Charles Bennet: “Doctors are not aware of the full range of toxicities with the quinolones.” UCSF Dean of Pharmacy: “I believe the petitions are worth considering, but only when there’s a preponderance of science behind it.” He says there is no good research to back up the petitions. However, there is overwhelming data suggesting the drugs are inappropriately prescribed for smaller infections like sinus, ear and throat infections. Experts say using a fluoroquinolone to kill a minor infection is like using a sledge hammer to kill a fly.
http://www.nbc-2.com/story/28971919/jims-story-change-headline#.VUjzvGdMtjo NBC2, Ft. Meyers, FL, May 4, 2015 “I traveled a lot, got to do a lot, I always jogged, but I haven’t been able to wear my jogging shoes in so long. I had a life, I could do stuff. It’s pretty much devastated our lives. This has affected every part of my body. We sit on the floor, and that’s about it, whatever we can do on the floor, I mean, my whole life is set up on the floor. By the end of the day, I can hardly remember the morning. I didn’t plan on it being permanent, and you know . . .” A dystonic attack during our interview forces Jamie to the floor. “I’m just so sick of this, I’m so sick of this, I can’t be normal, I just can’t do normal things.” The attacks cause her muscles to contract uncontrollably, she can suffer up to twenty a day. Neurologist David Perlmutter says: “They’re dramatically overprescribed. I’d say there’s very little doubt that it was directly related to Jamie taking those medications. The risks we now realize are profound and can be life long, long after the drug has been discontinued.” Even an FDA report showed that up to 60% of patients developed some sort of nerve damage within five days of starting the drugs, so the FDA recommended several label changes. That was two years ago, and still, nothing has been done.
http://www.wsbtv.com/news/news/local/new-calls-stronger-warning-about-popular-antibioti/nk7B5/ WSB-TV Atlanta Follow Up Stories, May 1, 2015, 2 Parts: Part 1: “I locked the bedroom door. I wouldn’t let anybody in. At some point I was beside the bed hiding on the floor,” says Judy, a nurse. She took just three doses of the drug for a fever following knee surgery. “I felt so paranoid and just saying things that I would have never said before. I accused people of trying to hurt me. It was really strange.” The FDA is now considering this petition to add “Serious Psychiatric Events” to this Black Box Warning label. Wendy says: “They gave me the drug Levaquin intravenously, I think, to save my life.” She began shaking, has trouble walking, but what’s worse, is her immune system is destroyed. She must wear a mask, and gloves, and rarely leaves home. “It’s affected my life, totally affected my life.” Cancer survivor Diane got the drug in the hospital as treatment for a brain tumor. The cancer is gone, but she endures painful physical therapy for the rotator cuff that disintegrated while she lay in bed. That risk was on the label, but she says, no one told her. “When I found out what I found out, that’s when I contacted you, because we have got to get the word out.” Nearly 5 million people have been reached with these news reports about this drug so far. A former insider, a retired vice president of research at the drug company, says there should be tougher warnings about the antibiotic Levaquin. He supports changes to the warning labels, and restraint in prescribing it. Part 2: Lesley says: “I was hospitalized twice. I was in tears, I was in so much pain, and nobody could tell me why.” She suffered tendon issues, and the muscle disease rhabdomyolysis, the same thing that killed Danelly after taking only two pills. Dr. Paul Schnipelsky, retired researcher and executive and J&J: “Something needs to be done. In this case, I think things are rising up out of the mire.”
http://www.kob.com/article/stories/S3780256.shtml#.VUDxSmdMty0 KOB-4, Albuquerque, NM April 28, 2015, 3 Part Series (Scroll to end of article to click on links for Part 2 and 3). One of the most commonly-prescribed drugs in America is causing severe and painful reactions to hundreds of thousands of people taking it, according to research done by the U.S. Food and Drug Administration (FDA) and medical doctors around the country . . . “It was terrifying and heartbreaking,” Joanne said. “The pain was indescribable . . . I was so damaged, that I couldn’t even perform the most basic of human functions . . .I remember taking half an hour to crawl from my bed to the bathroom because my joints and my tendons were so damaged that they tear so easily.” The potency of the pill sent Joanne’s body into what amounted to be years’ worth of pain. “At looking at the possible side effects, I think the only one I didn’t experience was agonal death struggle. My goodness, that means you’re dying in agony.” For Charlie, just getting from the car to the front door is a struggle, the muscles in his legs no longer work, the bones are supported by screws, his feet are now outfitted with these specialized boots. It could have been worse – some doctors just wanted to amputate his legs. “Before I was finished with the meds in the last couple of days, I started hurting. I virtually had to give up my life”. The drugs robbed him of enjoying his golden years, forcing him to spend the rest of his life with legs that don’t work.
http://www.nbcconnecticut.com/troubleshooters/Troubleshooters-Investigation-Pharmacy-Drugs-Prescription-Side-Effects-Antibiotic-301631121.html WVIT -NBC West Hartford, CT, April 28, 2015 . . . she felt numbness, tingling and pain with every step she took . . . “My heart breaks. I can’t dance anymore” . . . Despite the controversy, fluoroquinolone antibiotics are still widely used, and even overused . . . Both companies have filed answers denying any wrongdoing in connection with pending litigation.
http://www.wsoctv.com/news/news/special-reports/action-9-some-blame-certain-antibiotics-devastatin/nk4Ky/ April 27, ABC-WSOC-TV, 2015 Charlotte, NC. Some patients and doctors are blaming popular antibiotics for devastating side effects, including ALS/ Lou Gehrig’s disease, Alzheimer’s disease, Parkinson’s disease, and even death . . . “All of the joints in my body started popping . . .it’s ruined my life. I can’t go anywhere. I lay on my couch with pain every single day that’s so bad it feels like somebody is ripping flesh right off my bones” . A Georgia man’s wife says he was in great shape, got sick, went to urgent care, and got a prescription for Levofloxacin. She says he took just two pills and, days later, he was dead. Another victim says he had a sinus infection, took seven doses of the same medicine, and ended up hobbling around. “I may be one of those that’s crippled for the rest of my life. It’s terrifying.”
http://wric.com/2015/04/21/8news-investigates-could-this-antibiotic-permanently-damage-your-health/ April 24, 2015, ABC-WRIC Richmond, VA. “I was two weeks into taking Cipro and I lost the ability to talk. I suffered ringing in the ears, vertigo, sharp stabbing pains, numbness in limbs, panic attacks so severe I couldn’t sit down,” he said. “I can’t tie my own shoes anymore . . . I felt the tendon snap, and ball up in my calf, it was horrific” . . .since then, she’s had eight other tendons rupture and has numbness in her limbs.
https://www.facebook.com/KPRC2/posts/1053998554630197 April 14, 2015, KPRC2, Pittsburgh. Less than a year ago he was a healthy and vibrant 33 year old musician and personal trainer in the prime of his life . . . now, he can barely play his guitar. “I noticed around Day 7 or 8 into the medication, every time I would stand up I would be super fatigued, ears rang all the time, I had trouble walking, then in the second month, my shoulders hurt, my tendons hurt . . .my biggest fear is that my son is never going to know who I was”. Six days into her ten day dosage, she knew something wasn’t right . . . “I had heaviness in my thighs, pressure in my lower spine, my vertebrae felt like they were rubbing on each other and I could hear the snapping in them . . .I would not take it again if my life depended on it”.
http://pittsburgh.cbslocal.com/2015/04/07/local-doctors-explain-risks-of-taking-levaquin/#comments April 3, 2015, CBS KDKA Pittsburgh. They gave her the Levaquin antibiotics . . . six months later, she developed tendon troubles and couldn’t walk . . . After ten years of using a scooter around the house in chronic pain, at age 43, she committed suicide.
http://newyork.cbslocal.com/2015/04/03/seen-at-11-is-the-antibiotic-cipro-a-prescription-for-danger/ April 3 2015, CBS New York. “I wanted to be a firefighter since I was a kid,” Chris said. For 9 years he has been living that dream, but the last 5 months have been a nightmare. “I went on a walk with my dog after taking the medicine, and it felt like a bomb went off in my body . . . I just don’t know if I’m going to get better or not, and no one can tell me . . . The hardest thing is not knowing.”
http://cbs2iowa.com/news/features/top-stories/stories/Medication-Warning-110580.shtml?app_data=%7B%22pi%22%3A%22551dfcc2fee4266f6c000031%22%2C%22pt%22%3A%22wall%22%7D April 2, 2015 CBS News, KGAN Iowa. Permanent tremors and neurological symptoms, similar to Parkinson’s and ALS from just 2 pills: “48 hours after I was given the first pill, I woke up with tremors, which you can hear in my voice and see in my hands. Ringing in my ears that sounds like living in a tent full of cicadas . . . I took only 2 pills total . . . 8 days after stopping it, I was in a hotel room in Florida on a photographic trip and I woke up in the middle of the night feeling like there were hot pokers in my body. I couldn’t walk. I had trouble breathing. I was panicking.” Now two years later, the tremors are constant. Basic tasks like getting a drink of water are a challenge. There are no more photography hikes into the woods and her physical and cognitive issues forced her to retire early from her career.
http://www.wset.com/story/28654011/popular-antibiotic-may-be-causing-permanent-damage March 30, 2015, Lynchburg, VA. Smith says he only took Levaquin for 3 days and suffered from “depression from hell, crying all day and night for no reason at all . . . panic attacks, 24/7 anxiety that would not stop.” Similarly Kennedy says she was “in a state of extreme confusion & began experiencing severe panic attacks” after taking Cipro.
http://denver.cbslocal.com/2015/03/30/patients-reporting-serious-adverse-reactions-to-popular-antibiotics/#.VRqv7EQjdSg.twitter March 30, 2015, CBS Denver. “I have a burning pain, a numb-tingly pain,” he said. “I have a ripping pain, especially in my heart . . . After the first pill I noticed that I wasn’t able to follow conversations with coworkers . . . I woke up on Oct. 6, 2008 and I couldn’t feel my legs.” The former IT specialist can’t work anymore. The once athletic father dropped 60 pounds. “All I wanted to do was go hold my little boy before I died and let him know who I was.” Lisa said she developed vision problems, memory loss and painful joints. “I went from going to the gym every day to barely being able to walk . . . People’s lives are being destroyed by these drugs, and it’s not okay”.
http://www.aol.com/article/2015/03/27/dangerous-side-effect-of-popular-antibiotic/21158504/?icid=maing-grid7%7Chtmlws-main-bb%7Cdl16%7Csec1_lnk2%26pLid%3D634480 March 27, 2015 AOL. “My body seemed to completely slow down. … It was from my ankle all the way down to the bottom of my feet turned ice cold. But they were burning on the inside,” Nancy said. “On day seven I woke up and I was in so much pain everywhere. … I felt like I was dying,” added Dr. Susan Tannenbaum.
http://www.abcactionnews.com/money/consumer/taking-action-for-you/it-is-popular-and-powerful-antibiotic-but-is-it-dangerous March 26, 2015. ABC News Tampa, FL. Nancy says the pain hit on day five, severe side effects took over and she could barely walk. Seven months later, she remains too sick to return to work. Susan said she’s spent the last 12 months putting her life back together. A bout of bronchitis led to a prescription for Levaquin. By day seven she was unable to get out of bed, and describes being in the kind of pain that left her barely able to move and lasted for months.
http://chicago.cbslocal.com/2015/03/11/safety-advocate-powerful-antibiotics-being-overprescribed/ March 12, 2015 CBS Chicago. Melvin had to retire early from the Illinois State Police force. “I was a very healthy person at the time. I bicycled about seven to ten miles a day, I could bench-press 300 pounds.” Now, just helping his wife prepare a meal can be almost unbearable. “I have days I can’t lift a half a gallon of milk, and if I do, I have to go lay down and rest for a while. I don’t know what the future holds”. Through emails, people tell him: “the pain is almost unbearable,” and “I woke up one day in hell.” Caroline took Levaquin eight years ago for a sinus infection and hasn’t been the same since. “One day, I can be okay and focus and another day I can’t even talk to anybody because they are not making sense,” she said.
http://www.kctv5.com/story/28170151/fda-evaluates-popular-antibiotic-that-patients-say-makes-them-sicker March 11, 2015 Kansas City KCTV, MO. “It makes me angry. It is hard for me to even express just how angry I am. Because I feel doctors, pharmacists, medical practitioners should know about black box warning on drugs” . . . He underwent four tendon tear surgeries and started experiencing neurological disorders. “Even to this day I will have shooting pains in my hands and my feet. My hands will go numb, my feet will go numb.” But what hasn’t been disclosed is a condition called “mitochondrial toxicity” detailed in the 2013 internal FDA report. It is a condition that can lead to lasting neurodegenerative diseases.
http://losangeles.cbslocal.com/2015/03/04/southland-firefighter-says-popular-antibiotic-stripped-him-of-his-career/ March 4, 2015 CBS KNX Los Angeles. A Southland firefighter wants to warn others about a prescription drug that he says poisoned him and stripped him of the ability to do what he loves. Two days after starting the medication, he called his doctor about soreness he was feeling in his legs. The doctor said to keep taking the medication. Jones went to a specialist and told him about disturbing side effects patients were reporting online. He said the new doctor didn’t believe Ciprofloxacin caused those problems: “He told me to stay off the Internet, and he wrote me another prescription.” Jones starting feeling excruciating pain from his hips down. And no one missed the “old Chris” more than his twin brother, Jeremy: “We used to go to the gym together, hiking together.” They used to work at the same fire station, but he hasn’t worn his uniform for five months. That’s because he says he can’t climb ladders, can’t lift gurneys, and he can’t even lift his own children. “I was poisoned,” he said. Jones says the FDA acknowledges that some side effects could be permanent: “I just don’t know if I’m going to get better or not. And no one can tell me.”
http://dfw.cbslocal.com/2015/03/02/dangerous-antibiotic-could-be-responsible-for-deaths/ CBSDFW Dallas, March 2, 2015. “As I was walking through my house and stuff, I was thinking, there’s something wrong. I mean my foot hurt, my ankle hurts, my shoulder started hurting. I can’t do half of the things I used to do. It’s very depressing. It’s like my whole body is crumbling from the inside.”
http://kstp.com/news/stories/S3718761.shtml?cat=127 KSTP Minneapolis News Story, February 26, 2015. She only took four pills. Within days, she says the pain was unbearable. “I couldn’t walk. I couldn’t work.” She experienced hallucinations and severe pain in her tendons after she was prescribed a popular antibiotic to clear her sinuses in 2012. Doctors at the Mayo Clinic later determined she had suffered an adverse reaction to the generic form of Levaquin. She claims the doctor never warned her about the possible side effects. “We put our faith in the doctor’s judgment and we need to learn as patients that we can ask questions.”
http://www.wcnc.com/story/news/health/2015/02/24/devastating-side-effects-prompt-local-push-to-ban-antibiotic/23977183/ Charlotte, NC News Story, February 24, 2015. “Every day you push through it, you push through it because you have to,” Adrienne says. Adrienne endures grueling physical therapy several times a week; the 36-year-old mother of two struggles to walk. “It’s very painful for me, just because my Achilles hurts really bad, so in order for me to not lose strength in my legs, I have to do this. I just have to bear the pain.” It started last summer. Adrienne was diagnosed with a sinus infection; doctors prescribed Levaquin. A few days into the prescription she says, “I started having issues with my legs– my legs hurt, they burn, felt like I walked up hill all day, my feet hurt, I had problems with my eyes, my vision started becoming kind of blurred.” It took three months and four doctors to come up with a diagnosis. Adrienne’s neurologist says the Levaquin caused tendinopathy and peripheral neuropathy. So basically the drug attacked her nerves and tendons. Adrienne was shocked. “He said unfortunately you have nerve damage from taking Levaquin.” Her husband Shannon just wishes he could take away her pain. “It makes you wish, just like anybody you love, you could go back and do something about it. Like wish you had more time, researched more, maybe take it off her shoulders a little bit and put it on yours.”
http://miami.cbslocal.com/2015/02/24/powerful-antibiotic-could-be-a-prescription-for-danger-pt-ii/#comments CBS Miami Part 2: February 24, 2015. His life changed and he believes could end prematurely because of what he considers to be a toxic poisoning by the antibiotic Levaquin. “It has destroyed it, completely destroyed it. As you can see it has killed my teeth. It has destroyed my jaw. So I cannot have any oral surgery to repair it. It has dissolved my tendons and connective tissue. And my muscles have actually decayed and my prognosis is very dim,” shared King. He says “not only is the public not aware of this, the doctors are not aware of it either.” What is his goal now? “To make it each day,” said King. Redd also said he was damaged by taking this class of antibiotics five years ago. He “suffered a number of side effects. They have not resolved completely. ”
http://www.wfsb.com/story/28150135/griswold-man-sues-drug-maker-over-side-effects#.VOaAZuLxkfE.twitter February 19, 2015 WFSB Hartford Connecticut. A Griswold man said this drug has taken a serious toll on his body and completely changed his life. “I just thought that my body was for some reason just kind of falling apart on me,” Wickerd said. “It was just a hand injury that occurred while I was pulling hose on a fire truck.” He later ruptured several tendons and ligaments in his ankle and then injured his ACL. In total, Wickerd underwent six surgeries. But the problems didn’t end there. During a routine eye exam, his doctor discovered 13 retinal tears in his eyes. Finally, Wickerd developed nerve damage in his arm. Wickerd said it was all a mystery. That is until he heard that Levaquin was linked to tendon ruptures. “They had put out a black box warning on the drug,” Wickerd said. He learned that a study linked the drug to retinal detachment and decided to sue the maker of the drug, Johnson & Johnson. Wickerd wasn’t alone. The company settled hundreds of lawsuits with patients who took the drug. “What we’re starting to realize with these antibiotics is there are a lot of side effects,” said Dr. Ulysses Wu, with Saint Francis Hospital. “A lot of physicians may actually not know about the black box warning,” Wu said.
http://floxiehope.com/2015/02/06/media-coverage-of-fluoroquinolone-antibiotic-dangers/ WSB-TV2 Atlanta, 3 news stories done in Feb, 2015. Part 1: She says just two pills killed her husband. He was in the best shape of his life at 41, although he was always an athlete and stayed in shape. He was at his prime. The fitness enthusiast had just aced a physical. “Two pills and he was just stiff, and suffering. Their young children’s last vision of their father was of a man crying in pain, in a hospital emergency room, less than 48 hours after the first dose. Three days later, he was dead, which the autopsy found was due to “the adverse outcome of Levaquin”. Another man took 7 pills two years ago for a sinus infection. “I went from an athlete to a cripple, possibly for the rest of my life. It’s terrifying. For the people affected “their bodies are falling apart – it is horrific . . . most victims are left to suffer.” Part 2: Our story about death and injury from these drugs reached 1.5 million people in the first 24 hours. The warnings already posted about these drugs often don’t get through. Warnings about the risks to her legs had been out long before she took the drug in 2013 given to her for back surgery. She showed the scar where a surgeon had to rebuild the Achilles tendon 3 weeks ago. “My doctor did not give me any warning about that, no one said anything, and the pharmacists didn’t say anything either.” Plastic surgeon Keith Jeffords emailed the news station too. “It was an amazing amount of pain, to the point that I literally couldn’t walk.” He received the brand name Levaquin after ulcer surgery. When his doctor refused to switch the drug, Jeffords fled the hospital. “They took me down to the base of the hospital in a wheelchair and I crawled on all fours out to my car and drove home”. Jeffords says, he never got the warning either. “I’ll tell you, as someone who has been through Levaquin, you know, I will not prescribe that drug in my office.” Jeffords says his legs were weak for months. (My note: An excellent example of how physicians don’t know anymore than the rest of the general population about the true dangers of these antibiotics, and they are as susceptible to these adverse effects as anyone else. Plenty of physicians and other medical professionals have become flox victims, see here: FQ Adverse Effects In Their Own Words from Physicians. ) Part 3: A second Georgia widow is coming forward to tell the pill is suspected in her husband’s death. This story is the most read story on our website in the past two years, and has reached nearly 4 million people now. Sandy wanted me to put her husband’s death certificate on television. His death certificate says acute liver failure, possible reaction to antibiotic. She says she didn’t realize the volume of complaints about levofloxacin. “After I heard the story the other night, I said ‘wow’. I don’t think it should even be on the market. If it’s killing people — no”. Kathy Danelly says “It’s shocking, to see how many people, once you start looking at the numbers, how many people have been affected by this family of drugs.” Another local family is now awaiting autopsy reports on another patient who died after five days on the medication.
http://www.wsbtv.com/news/news/local/levofloxacin-users-share-antibiotics-success-stori/nj8H6/ WSB TV Atlanta News Story Follow Up February 10, 2015. “I’ll tell you that black box warning, that’s pretty scary.” He has experienced severe tendon pain while on the drug. He suspends his daily workout routine while taking the drug. However, after seeing Strickland’s investigation, Howard says he’ll seek alternatives. “I have my next biopsy in June, and I’m going to ask my doctor if there’s and alternate prescription that I can take,” Howard told Strickland. Jarrad says taking the pill is necessary and, for him, so uneventful that he swallowed the final pill of his 10-day regimen in front of Strickland. “I think there are two sides to every story and mine has been very good,” said chronic sinus infection sufferer David Jarrad.
http://www.pbs.org/newshour/bb/health/jan-june11/antibiotics_06-16.html PBS News Hour Story, June 16, 2011. (My note: Reading the comments after the video are enlightening). Certain Antibiotics Spur Widening Reports of Severe Side Effects. Jen took a prescription drug called Levaquin to prevent infection following routine sinus surgery, and developed severe pain in her joints and muscles, and even when she stopped taking the medication, the symptoms grew worse, until she could no longer walk. “I couldn’t even hold my head up. And I was bedridden for over a year. And when I say that, I mean, I couldn’t even get myself out of bed to get into my wheelchair to go use the restroom. I had to be picked up out of bed.” Today, with the help of her husband, Wilcox struggles through at least three therapy sessions a week. Her neurologist continues to treat her for Levaquin toxicity. The medical problems have also taken their toll on her quality of life. She became so disabled she had to give up her teaching job. And, without her income, the family lost their home. John was prescribed Levaquin a few years ago for a minor bacterial infection. Before taking Levaquin, he had no major medical problems. But after taking the drug he became disabled. “It caused nerve damage, tendon damage and central nervous system damage. Central nervous system damage is — is brain damage. I have lost my job. I have lost over a quarter of a million dollars in lost wages. I have spent about $30,000 out of my own pocket in medical and insurance costs, haven’t received a dime back for this.” Concern about the adverse side effects of quinolones got national attention some years ago, when Philadelphia writer Stephen Fried’s wife became psychotic and developed seizures after taking just one pill: “It turns out that what is happening to her is — is a possible side effect of the drug that she took one pill of that morning. And so we were then launched into this mysterious, scary, fascinating, intellectually challenging, emotionally challenging world of adverse drug reactions, and looking for answers to her situation.” Five years of digging led Fried to write the book “Bitter Pills” that was a bestseller. “I think that it’s fairly clear that adverse drug reactions have been considered for some time to be the fourth leading cause of death in America. I think it’s an accurate number. And so the number has always been bandied about between 100,000 and 200,000 a year.” It’s hard to know how many Americans are harmed by quinolones, or any prescription drug, for that matter, because the U.S. has no accurate way to track them. The Food and Drug Administration does have something called the Adverse Events Reporting System, or AERS, but even FDA says that picks up only about 10 percent, which means about 90 percent of all adverse drug reactions go unreported. Dr. Ray Woosley says the only way to settle a drug safety issue like quinolones is for the U.S. to develop a reliable system to accurately track adverse drug reactions. “As a nation, we don’t have a fair and effective system that serves the drug industry or the patients or the caregivers. Everyone is suffering in some way because of our lack of investment in the safe use of medicines. You can go on the Internet and you can print out a list of all the companies and how many suitcases the airlines have lost each month for over a decade. But I can’t go anywhere and tell you how many people were harmed.”
http://www.youtube.com/watch?v=Scyd59nUG7s 16X9 Canadian News Story: Bitter Pills: Side Effects of Fluoroquinolones. Mark says: “There’s two chapters to my life, before I took Levaquin, and since I took Levaquin, and it’s been terrible. I lived at the top of the Colorado Rockies and worked at ski resorts. Within weeks of taking the Levaquin for a surgery, the swelling and the pain began.” Eventually he had to have another surgery to repair the torn tendons. “This scar here is where my peroneal tendon is ruptured. There was no warning, no discussion of possible side effects whatsoever. Since then, I’ve got one problem after another, after another, after another, and it doesn’t look like it’s going to end, and I’m broke, and I’ve lost everything. I’m depressed. I think about suicide every day.” Marsha, a professional ballet dancer says: “The tinnitus will never go away, and the Achilles pain will probably be forever, it’s been over a year now. It’s unbearably devastating, to think that I’m going to have to stop what I love more than anything. I’m heartbroken because dancing is my life, teaching is my life, and I’m very worried that I’m not able to do that now.” Guille, an IT worker says: “It felt like everything from head to toe was hurting, it was just like this throbbing pain everywhere in my body”. He is now on disability, the pain making him a prisoner in his own home. “I hardly ever leave the house. It’s very hard to think about the future right now, since there’s not much I can actually do. It’s very depressing. This misinformation is fatal, basically, it sealed my fate.” Young says: “I found more and more corrupt practices that prevented doctors and patients learning what the true risks of prescription drugs were. And the reason that’s happened is because of the incredible marketing power of the pharmaceutical industry. These are the wealthiest companies in the world in many cases.” Merchant says: “The drug industry has gone off on a very bad tract. They knew, or ought to have known, about the problems (going back to the 1980’s) and they didn’t disclose them. They didn’t give to doctors the real opportunity to select another drug instead of these drugs, putting their patients at risk as a result.”
http://abclocal.go.com/wtvd/story?section=new%2Fabc11_investigates&id=8414971 Raleigh NC local news story, November 3, 2011. “‘We’re gonna give you an antibiotic,'” Terry said a nurse told her. “And said: ‘You should start feeling some effects from it in a few minutes.’ Well in just a few minutes, I did.” She was given the drug intravenously, and she said two months later, she had a hard time walking and went to her doctor to find out why. “And he ran all kinds of tests on me and checked me and he said ‘Ms. Ennis your Achilles tendon is ruptured and pulled apart.'” The Achilles tendon connects the foot and leg – making it possible to walk. Ennis says she was never told about the side effect warnings that come with Levaquin. And, she says she has had to endure several operations – with little success – and takes dozens of pills for other complications from the rupture. “I feel like I’ve been to hell and back with my legs because they hurt so bad,” she said. “It’s forever changed my life.” More than 3,000 patients are now suing the maker of Levaquin, Janssen Pharmaceuticals, Inc. Ennis is considering joining the lawsuit. The patients say they’ve suffered from side effects including ruptures of the Achilles tendon, shoulders, biceps, hand, and thumb. Ennis said that if she was told about Levaquin’s side effects, she would have refused it at the hospital. She said it’s ruined her life. “I sit in my chair sometimes and I don’t do nothing but cry. Because I see so much that I want to do. I can’t do it anymore,” she said. John says “…It has now been two years, and every single moment of every single day is a mighty struggle.”
http://www.newsnet5.com/dpp/news/health/antibiotics-side-effects-catch-patients-by-surprise Denver local news story, July 6, 2012. “Every step I’d take I’d pop, my back was popping. It’s not just the ligament issues. I’ve had muscle wasting. I’ve lost 25 pounds. When I go out I go in a wheel chair. I almost feel like the front of my shins, like the connective tissue is pulling away from the bone. It’s a scary drug. These are scary drugs.” Figler has been diagnosed with tissue degeneration, specifically tendinopathy and neuropathy, caused by antibiotics she was prescribed called fluoroquinolones. The antibiotics can directly attack and destroy tendon tissues. “The damage that was done to the tissues is going to last for a very long time and perhaps permanently,” said Figler’s physician. “At the end of the day it’s the physician’s responsibility to first do no harm.” He said that includes using these antibiotics only when absolutely necessary, not as a first line of treatment. Figler says her condition was 100 percent preventable. “It hurt for several weeks and a while later I realized I couldn’t straighten my arm,” said Tom. After a few painful rounds of golf, he said his doctor confirmed the side effects were a result of the drugs. “I stopped using it because I didn’t want to have severe damage to the tendon,” he said.
http://www.youtube.com/watch?v=tWns15Y5TdI “Certain Adverse Events”: 30 min or so documentary about these drugs and the inadequacy of the drug safety and monitoring system; several more victims stories within the various parts; this is part one of six. Uploaded to YouTube May 30, 2009
https://www.youtube.com/watch?v=8Seoobw2-CE&list=PLFDE0CCDB8D53FAC0&index=6 Ivanhoe News Story, Uploaded June 1 2009. “It’s been a hellish three and a half years. I haven’t been able to work in over three years. I didn’t know if I was going to make it. I was simply given a legal pill called Levaquin, and that’s ruined my life. I’ve now been diagnosed as suffering from ‘Levaquin-induced brain damage’, damage to my nerves, and damage to my tendons. We live here in America and we should be afforded the right to know that a drug can cause irreversible damage”. Bob says: “I call it, my head exploded. It just exploded. Now my life is just a living hell.” Dr. Sidney Wolfe: “The FDA and the Industry are doing a terrible job assuring the public that what they are getting after a doctor writes a prescription for them, is really adequately safe.” The FDA refused to talk with us for the story.
https://www.youtube.com/watch?v=GBkIgki9tCE&index=10&list=PLFDE0CCDB8D53FAC0 MSNBC Cipro Black Box Warning, Uploaded July 8, 2008. The FDA has just issued the highest warning for the antibiotic Cipro, calling for the use of the so called “Black Box Warning” label.
https://www.youtube.com/watch?v=0hmXc2ujNfI&list=PLFDE0CCDB8D53FAC0&index=11 FOX News, Black Box Warning for FQ’s, Uploaded September 25, 2008. There’s an urgent warning about a very popular class of antibiotics, including the popular drug Cipro. With the fluoroquinolones, we’ve seen, in the literature, since the late eighties, an association of tendinitis and tendon ruptures. Prescribers need to be aware, patients need to be aware, that this is a serious adverse effect. This can be made worse with steroids
https://www.youtube.com/watch?v=qR_zRL0cO-U&list=PLFDE0CCDB8D53FAC0&index=12 CBS Healthwatch, Black Box Warning, Uploaded July 9, 2008
https://www.youtube.com/watch?v=DOhFVskXJhQ&list=PLFDE0CCDB8D53FAC0&index=15 LegalTube Alert about FQ’s and Tendinopathies, Uploaded October 26, 2009
https://www.youtube.com/watch?v=ZjlxxzleL6s&list=PLFDE0CCDB8D53FAC0&index=17 Uploaded on Apr 7, 2011. Hi-Tech Pharmacal announced that the FDA granted tentative approval for the company’s Abbreviated New Drug Application for levofloxacin oral solution 25mg/mL, the generic for McNeil Pharmaceutical’s Levaquin oral solution which had sales of $6M for the 12 months ended December 2010 according to IMS sales data. The product is indicated for the treatment of adults with mild (!), moderate(!) (emphasis mine) and severe infections. The company expects to receive final approval from the FDA in June when the brand’s pediatric exclusivity expires related to patent number 5,053,407. Hi-Tech plans to launch in June 2011 upon receipt of final approval.
https://www.youtube.com/watch?v=4EjNxYP9Swg&list=PLFDE0CCDB8D53FAC0&index=20 Uploaded on Feb 4, 2009. A federal appeals court revived two lawsuits brought against the drug giant Pfizer by Nigerian families who say the company used their children in an illegal test of an experimental antibiotic (Trovafloxacin http://en.wikipedia.org/wiki/Trovafloxacin ). More news stories about this on YouTube under “FQ News & Media”.
http://www.amazon.com/East-Marling/dp/B00DVD5STQ/ref=sr_1_1?s=movies-tv&ie=UTF8&qid=1424621301&sr=1-1&keywords=the+east “The East”. Read about the movie as it relates to FQ Toxicity here: http://floxiehope.com/2013/06/24/fluoroquinolone-toxicity-movie-the-east/
https://www.youtube.com/watch?v=YQZ2UeOTO3I John Oliver: Marketing to Doctors. The real reasons FQ’s are prescribed as a first line antibiotic for everything under the sun. A must see. Skip to 15:20 for the “TV Commercial” if nothing else.