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Post by Mayleng on Apr 4, 2015 10:20:44 GMT -5
newyork.cbslocal.com/2015/04/03/seen-at-11-is-the-antibiotic-cipro-a-prescription-for-danger/NEW YORK (CBSNewYork) — Cipro is a common antibiotic that is prescribed for treating a number of bacterial infections, but some say it may be a prescription for danger. “I wanted to be a firefighter since I was a kid,” Chris Jones said. For 9 years Jones has been living that dream, but the last 5 months have been a nightmare. “My life flipped upside down,” he told CBS2’s Dick Brennan. Flipped upside down, he said, because of crippling side effects he experienced after taking the popular antibiotic Ciprofloxacin or Cipro as it is more commonly known. “I went on a walk with my dog after taking the medicine, and it felt like a bomb went off in my body,” he said. It’s pain that continued ever since, especially in his legs. “His story is so, to me, typical of many of the stories I’ve read about and looked through the FDA files on,” Dr. Charles Bennett said. Dr. Bennett is a professor of pharmacy who recently filed a petition asking the FDA to put broader warnings on Cipro. the medication is part of a class of antibiotics called quinolones, along with the drugs Levaquin and Avelox. “Doctors are not aware of the full range of toxicities that are associated with the quinolones,” Bennett said. Critics also charge that the drugs, which are so strong they can kill anthrax, are too freely prescribed for illnesses that could be treated with less powerful medications. “They haven’t done a good enough job warning the public about how dangerous this drug is,” Jones said. The FDA said it’s logged just 4,500 reports of serious side effects, an exceedingly small percentage considering 23-million prescriptions are filled each year. Drug makers already list side effects including the possibility for tendon and nerve damage on the labels. “I just don’t know if I’m going to get better or not, and no one can tell me,” Jones said. Jones is living with the pain and other side effects, which even the FDA acknowledged may be permanent in some people. “The hardest thing is not knowing,” Jones said. The FDA told CBS2 it’s continuing to monitor complaints. Bayer, the maker of Cipro, said in a statement that they encourage patients to speak with their healthcare providers regarding any symptoms that they may experience after taking a prescription product.
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Post by Mayleng on Apr 29, 2015 7:46:52 GMT -5
www.kob.com/article/stories/S3780256.shtml#.VUDScSFVikrOne 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. The line of antibiotics is called fluoroquinolones. They are more commonly referred to by their product names or sponsors, which are: Noroxin® (norfloxacin)—Merck and Co. Cirpo® Cipro XR® (ciprofloxacin)—Bayer HealthCare Levaquin® (levofloxacin)—Janssen Pharmaceuticals Avelox® (moxifloxican)—Bayer HealthCare Factive® (gemifloxican)—Cornerstone Therapeutics Ofloxacin—generic Albuquerque resident Joanne Corwin used Cipro® four years ago for an uncomplicated urinary tract infection. By the 12th pill, Joanne told KOB 4 her body was rejecting it in the most painful and agonizing way. "It was terrifying and heartbreaking," Joanne said. "The pain was indescribable." Fluoroquinolones are like the bazookas in the arsenal of antibiotics. They are very strong and often doctors will prescribe them to treat minor infections. But it's like using a cannon to kill a fly. The potency of the pill sent Joanne's body into what amounted to be years' worth of pain. This is a list of just a few of the side effects Joanne says she experienced: Hair loss Constant ringing in her ears Retinal damage, leaving black spots in her vision Onset depression and anxiety Inability to swallow Intolerance to many foods Kidney damage Liver damage Arrhythmia Painful joints and tendons Burning sensation on the skin Skin rashes and sores Muscle Atrophy Sudden seizures "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," Joanne said. Fluoroquinolones come with a long list of warnings, usually in small print accompanying the prescription. Charles Bennett, M.D. is a leading researcher on fluoroquinolones. He spoke with KOB 4 from his office at the University of South Carolina. "You're talking about hundreds of thousands of people with a side effect," Dr. Bennett said. Dr. Bennett's work in 2004 led the FDA to add a black box warning to fluoroquinolones. A black box warning is the highest level of a warning the FDA can add to a drug to encourage doctors and consumers to read the potential side effects. Dr. Bennett is now petitioning the FDA to add another warning regarding possible mitochondrial toxicity. In short, mitochondrial toxicity is a breakdown of your body's cells. In April, 2013, the FDA released its own research findings that showed a link of fluoroquinolone usage to mitochondrial toxicity. The same report shows the toxicity could lead to neurodegenerative diseases such as Parkinson's, Alzheimer's and ALS. "Would it be accurate to say that if you're taking fluoroquinolones today, there could be a latent effect later in life…maybe 10, 15 years down the road?" asked 4 Investigates Reporter Chris Ramirez. "That's a very important question," answered Dr. Bennett. "We've seen a delayed onset of people who use the drug, then have toxicity that we would potentially associate with the drug. But to verify these latent toxicities, it will take a tremendous amount of science. But that is our working hypothesis." Joanne, who is a normally a private person, is stepping out of her comfort zone and taking on an advocacy role to encourage the FDA to add the mitochondrial toxicity warning to fluoroquinolones. She also shared her story in the hopes it would encourage more dialogue between physicians and their patients about drug side effects. She hopes patients have the courage to question their doctors about any kind of treatment they prescribe. And Joanne hopes people know---no one knows your body like you do, not even your doctor.
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Post by Mayleng on Apr 29, 2015 7:50:57 GMT -5
www.wcnc.com/story/news/health/2015/02/24/devastating-side-effects-prompt-local-push-to-ban-antibiotic/23977183/HARLOTTE, N.C. -- It is a commonly prescribed antibiotic-- doctors offer it for everything from urinary tract infections to sinus infections. But a local mom is pushing to get Levaquin off the shelves after she suffered devastating side effects. And a drug watchdog group is pushing the FDA for tougher warning labels. Shannon Myers is trying to slyly wrap his Valentine's day gift for wife Adrienne. The two are very much in love and very much a team– no matter what. "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, the brand name for a drug called Levofloaxacin. 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. Dr. Ki Jung, Adrienne's neurologist, says the Levaquin caused tendinopathy and peripheral neuropathy. He says he helped rule other things out and worked on a timeline to figure out what happened. Jung says, "I told Adrienne, let's put a timeline to this and see where we are and then see if we can tease out any correlations; that's really where we were able to get to the notion that this was a Levaquin problem." "So basically the drug attacked her nerves and tendons?" "Correct, in terms of a side effect profile." Adrienne was shocked. "He said unfortunately you have nerve damage from taking Levaquin." Dr. Charles Bennett chairs a drug watchdog agency at the University of South Carolina. He was not at all surprised to hear Adrienne's story. "I'm not surprised. I've been working on this for years. This woman is a story that's replicated in city after city, case after case." He recently petitioned the FDA for new, what's called black box warnings for Levaquin, those are bold warnings meant to grab your attention. The FDA already required black box warnings in 2008, warning of possible tendon rupture and muscle weakness. And in 2013 the FDA required a label change warning of nerve damage. Bennett says the FDA's own stats show 1200 people have died and nearly 100,000 have suffered side effects from Levaquin or Levofloaxcin. "Thankfully it's not life threatening for me. I'm very fortunate that it has not been a life threatening thing for me, so I think about the positive and hopefully my nerves will regenerate themselves and become healthy again," Adrienne says. 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." NBC Charlotte reached out to Levaquin for a statement. They responded Tuesday evening: "LEVAQUIN® (levofloxacin) Tablets is part of an important class of anti-infective prescription medications that have been used for more than 20 years to treat infections, including those that may be serious or life threatening. When used according to the product labeling, LEVAQUIN® has been proven to have a favorable benefit-risk profile." The best advice: ask your doctor and your pharmacist to go over the possible side effects of this drug-- or any other for that matter, and if you have concerns, ask for an alternative.
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Post by Mayleng on May 21, 2015 8:41:59 GMT -5
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Post by Mayleng on Jun 2, 2015 8:43:48 GMT -5
wric.com/2015/06/01/fda-researchers-looking-into-prescription-drug-after-complaints-8news-investigation/"WRIC) — 8News has confirmed complaints about some commonly prescribed antibiotics are now getting new attention from the FDA and medical researchers. Cipro, part of a family of drugs called Fluorouquinolones, is powerful enough to treat anthrax and is widely prescribed for everything from ear infections to sinus infections. We’ve confirmed that the FDA recently met with a group of folks who believe these popular antibiotics were nothing but a prescription for pain. 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."
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Post by Mayleng on Jun 12, 2015 15:04:31 GMT -5
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Post by Mayleng on Jul 28, 2015 10:33:31 GMT -5
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Post by dhfl143 on Aug 4, 2015 6:08:06 GMT -5
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Post by Mayleng on Nov 7, 2015 12:09:07 GMT -5
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Post by Mayleng on Nov 7, 2015 12:09:51 GMT -5
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Post by Mayleng on Nov 7, 2015 12:10:16 GMT -5
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Post by Mayleng on Nov 7, 2015 12:10:42 GMT -5
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Post by Mayleng on Nov 7, 2015 12:11:03 GMT -5
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Post by dw on May 14, 2016 7:55:38 GMT -5
FYI: FDA statement FDA Drug Safety Communication FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together Safety Announcement [05-12-2016] The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolone should be reserved for those who do not have alternative treatment options. An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) 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. As a result, we are requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. We are continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available. Patients should contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations. Patients should talk with your health care professional if you have any questions or concerns. Health care professionals should stop systemic fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course. Fluoroquinolone drugs work by killing or stopping the growth of bacteria that can cause illness (see List of Currently Available FDA-approved Fluoroquinolones for Systemic Use). List of Currently Available FDA-approved Fluoroquinolone Antibacterial Drugs for Systemic Use Brand Name Active Ingredient Avelox Moxifloxacin+ Cipro Ciprofloxacin+ Cipro extended-release* Ciprofloxacin extended-release+ Factive Gemifloxacin+ Levaquin Levofloxacin+ Moxifloxacin Injection Moxifloxacin Ofloxacin* Ofloxacin + available as generic * available only as generic We previously communicated safety information associated with systemic fluoroquinolone antibacterial drugs in August 2013 and July 2008. The safety issues described in this Drug Safety Communication were also discussed at an FDA Advisory Committee meeting in November 2015. We urge patients and health care professionals to report side effects involving fluoroquinolone antibacterial drugs and other drugs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page. Related Information The FDA's Drug Review Process: Ensuring Drugs are Safe and Effective www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143534.htmThinking it Through: Managing the Benefits and Risks of Medicines www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143558.htmAdvisory Committees: Critical to the FDA's Product Review Process www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143538.htm |
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Post by Mayleng on May 17, 2016 12:05:59 GMT -5
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Post by Mayleng on May 17, 2016 12:07:12 GMT -5
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Post by Mayleng on May 19, 2016 7:48:09 GMT -5
Physicians React to New FDA Warning on Cipro, Similar Drugs
MedPage Today
MedPage Today
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Post by Mayleng on Jun 9, 2016 10:00:52 GMT -5
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Post by Mayleng on Jul 28, 2016 9:54:25 GMT -5
www.aafp.org/news/health-of-the-public/20160727fluoroquinolones.htmlFDA Safety Alert Use Fluoroquinolones Only as Drug of Last Resort for Some Infections July 27, 2016 07:13 pm News Staff – Before you reach for the proverbial prescription pad for a patient with an acute bacterial sinus infection, consider this: The FDA has upped the stakes when it comes to warning prescribers and patients about the possible adverse effects of systemic fluoroquinolone use. [Man walking on crutches] According to a July 26 FDA Drug Safety Communication(www.fda.gov), these medications have been associated with disabling and potentially permanent side effects involving tendons, muscles and/or joints, as well as peripheral nerves and the central nervous system. Some patients may even experience more than one such adverse effect. Therefore, said FDA officials, "fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB) and uncomplicated urinary tract infections (UTIs), because the risk of these serious side effects generally outweighs the benefits in these patients." "Fluoroquinolones have risks and benefits that should be considered very carefully," said Edward Cox, M.D., director of the Office of Antimicrobial Products in the agency's Center for Drug Evaluation and Research, in a news release(www.fda.gov). "It's important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use." The agency has revised the boxed warning for all drugs in this class of antibiotics to reflect these serious safety concerns. Those drugs are moxifloxacin (Avelox) ciprofloxacin (Cipro) ciprofloxacin extended-release (Cipro extended-release) gemifloxacin (Factive) levofloxacin (Levaquin) and ofloxacin (Ofloxacin generic brand). Other sections of the drugs' labels have also been updated with new warning language, and their respective patient Medication Guides have been revised. The FDA based its actions on a review of placebo-controlled clinical trial results involving various antibacterial drugs used in patients with ABS, ABECB and uncomplicated UTIs. Although some trials showed a treatment benefit for ABS and ABECB cases, and most trials showed a treatment benefit for uncomplicated UTIs, many patients who received placebo also saw clinical resolution of infection. In addition, FDA officials evaluated postmarketing reports of adverse events associated with fluoroquinolones to re-evaluate their relative risks and benefits in treating these conditions. A search of the FDA Adverse Event Reporting System database from November 1997 to May 2015 identified 178 cases in which apparently healthy patients who took an oral fluoroquinolone to treat ABS, ABECB or uncomplicated UTI developed disabling and potentially irreversible adverse reactions. Mean duration of these reactions was 14 months, with the longest duration reported at nine years. Three out of four cases occurred in patients ages 30-59 years. Specific events reported include tendinitis and tendon rupture, muscle pain or weakness, joint pain and/or joint swelling, peripheral neuropathy, and central nervous system effects (e.g., psychosis, anxiety, depression, suicidal thoughts). Effects can begin within hours of starting the medications, but they may not be seen until after weeks of treatment. Patients should be advised to discontinue the drugs immediately if they experience any serious adverse effects. The benefits of fluoroquinolones continue to outweigh the risks when used for certain serious bacterial infections (e.g., pneumonia, intra-abdominal infections) and the FDA says it is appropriate for them to remain available as a therapeutic option in such cases. Related AAFP News Coverage Systemic Fluoroquinolones Pose Threat to Patients With Diabetes Reports of Peripheral Neuropathy, Dysglycemia Suggest Caution When Prescribing (8/27/2013) Fluoroquinolones May Increase Risk for Retinal Detachment, Study Finds (5/1/5/2012)
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Post by healthy11 on Jul 28, 2016 16:11:32 GMT -5
Although I wish they'd been able to recognize the potential dangers BEFORE so many people were impacted, I'm glad that they no longer deny the problem exists, and are trying to minimize the number of future cases. Mayleng, have you had any reduction in the severity of your symptoms over time? It's somewhat encouraging to hear that "mean duration of these reactions was 14 months," so hopefully there is still chance for improvement.
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Post by Mayleng on Jul 28, 2016 22:04:34 GMT -5
Unfortunately no reduction in pain and discomfort, it just changes from one area to another. There is no cure, many have gotten worse or remain the same or very slight improvement but NO ONE has ever been completely cured. Doctors are still in denial and don't read the blackbox warnings and are still prescribing them like candy.
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Post by Mayleng on Aug 1, 2016 9:47:48 GMT -5
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Post by dhfl143 on Mar 20, 2017 23:06:26 GMT -5
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