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August 2008
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FDA requests warnings on fluoroquinolone antimicrobial drugs
August 7, 2008 — The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Through its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency also determined that it is necessary for manufacturers of the drugs to provide a Medication Guide to patients about possible side effects.
The FDA has notified the manufacturers of these drugs that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of the drug outweigh the risks. The Medication Guide will be considered to be an element of the REMS. The new Boxed Warning and Medication Guide would strengthen warning information already included in product labeling for the fluoroquinolone class of systemic antimicrobial drugs.
Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones do not treat viral infections such as colds or flu.
The FDA has conducted a new analysis of the available literature and post-marketing adverse event reports. This new analysisreconfirmsthat use of fluoroquinolones is associated with an increased risk of tendon rupture. It alsodemonstrates that despite the current warning of tendon rupture in the labeling for the fluoroquinolones, large numbers of tendon-related adverse events continue to be reported. The FDA considers this new analysis to be "new safety information" as defined in FDAAA.
The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in people older than 60, in those taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients. Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should be advised to stop taking
Manufacturers are being notified of the need to change labeling so that all of the drugs in the class carry uniform updated warning language. These warnings would apply to fluoroquinolones for systemic use (e.g., pills, tablets, capsules and injectable formulations). The warnings would not apply to fluoroquinolones for topical ophthalmic or otic use (e.g., eye and ear drops).
Fluoroquinolone manufacturers are required to submit the safety labeling changes, including the strengthened warnings and the Medication Guide, to the FDA within 30 days, or to provide a reason why they do not believe such labeling changes are necessary. If they do not submit new language, or the FDA disagrees with the new language the company proposes, FDAAA provides strict timelines for resolving the labeling changes and allows the agency to issue an order directing the labeling change as deemed appropriate to address the new safety information. In addition, in accordance with FDAAA, sponsors will be required to assess whether their REMS are achieving the goal of informing patients of the risk of tendon-rupture. These assessments may include a survey of patients' and prescribers' understanding of the risks of tendon-rupture and whether the Medication Guide is being distributed and dispensed with the drug.
The medications involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin and generic ofloxacin.
Source: New York State Chiropractic Association, www.nysca.com
U.S. Food and Drug Administration, www.fda.gov
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Location: everywhere
The multi systemic damage these pills cause is a tragedy and a crime. It is a tragedy because the patient trusted the doctor who trusted the pill. (I wonder how seriously they take what they prescribe - how can they NOT know or NOT believe these things happen?) And it is a crime because there are those who know full well what this does to people, and yet the pills are still being sold. Quins changed my life forever, the effect was sudden and devastating and multi systemic. I got no answers from doctors. I did get a lot of mockery. Some were compassionate yet baffled. Most were dismissive or even mocking. Prescribing something this toxic without even testing to see if someone's bladder or sinus infection is bacterial, viral or fungal is criminal negligence in my book. I make no plans any more. I am like a living dead. I had a life before this. Now I just linger. Some have it even worse. But not getting out of bed most days when I was healthy and active and looked younger than my years is bad enough. I had tendon ruptures that lasted over a year snapping over and over again. I have loss of sensations, touch, taste, etc. Vision and dental health worse due to severe dry eye/dry mouth. So many symptoms large and small. If this can CHANGE DNA what is it doing on the market!? THINK doctors. THINK!Location: Illinois
My name is Leslea and I am a Clinical Laboratory Manager, have been a Medical Technologist for almost 30 years. I am very well respected by the medical staff at my facility because if I bring up a subject, perhaps a laboratory protocol that I want to put into place or changed, I have done my homework on the subject. With that in mind, I want to urge physicians to take heed to the fact that fluoroquinolones are not safe for a very large segment of the population. There are literally thousands and thousands of people whose lives are forever changed because of the quinolones. I know that most, if not all, facilities with microbiology departments put out an antibiogram, at least annually, for the medical staff to reference. Please use your antibiograms to pick the least toxic and most effective antibiotic for your patient. Use the quinolone class only as a last resort, after other antibiotics have failed or the patient will expire if they aren’t used. Using the quinolones routinely just doesn’t make sense when other antibiotics will work. Keep in mind if this class of antibiotics continues to be used so nonchalantly they will become ineffective due to bacteria developing resistance to them. I have personally experienced multiple system adr’s to the quinolones, and know a multitude of people like me. That is why I am writing this, I want to prevent the number of people that are damaged by quinolones from growing exponentially. The adr’s to the quinolones are grossly under reported due to the fact that a lot of reactions aren’t recognized, but are diagnosed as an unrelated problem. If the number of adr’s to quinolones were accurately reported to the medical community, no physician would ever routinely prescribe quinolones again, unless he was some sort of sadist. My motivation for writing this is honorable, our term would be risk management in the medical community, for the layperson it would be a passionate desire to prevent others from suffering like I am. Just in case you are wondering, my first reaction to a quinolone caused damage to my tendons particularly my left knee. The tendons were so weak that my knee dislocated 6 times over a 7 month period, I probably should have been in a wheel chair, but I needed to work. I have a permanent baker’s cyst in that knee. The tendonitis was so painful that walking was more like hobbling. My second reaction made my first reaction seem like a walk in the park. When I mentioned multiple systems earlier, I meant CNS, muscular, skeletal, soft tissues and connective tissue damage. Four and a half years post two doses of Avelox, I still have a multitude of symptoms, some that are not going to resolve. Although I am in severe unrelenting pain, I consider the worst part of my reaction to be the CNS or brain damage. I have debilitating depression, which I never had prior to this. But the thing that takes the cake is the following: I am sure you can imagine that I am or actually was above average in intelligence, Avelox has destroyed my short term memory and has made me struggle to find simple everyday words when carrying on a conversation. My nickname used to be “The Steel Trap” because I never forgot anything and could recall verbatim conversations no matter how long or short the amount of time that had elapsed. My memory was what is called photographic in nature. You might be tempted to say, well you are getting older, well I don’t believe that CNS changes due to aging happen overnight unless there is a stroke involved. That, and the fact that I am not alone with this reaction, speaks very loudly to the truth of the matter. I will quickly list the other damage I am dealing with; peripheral neuropathy, myofascial damage in my right hip that has lead to permanent gluteus median adhesions after tearing. I have chronic muscle spasms and knots in my right hip and shoulder, this is the cause of the severe unrelenting pain, the shoulder knots and spasms lead to horrible tension headaches. I also have to take Valtrex to keep shingles at bay, another wonderful symptom of the nerve damage. My tendons and ligaments in my right knee are tender to the touch and painful, my vision is altered due to floaters and blurring, luckily laboratories are notoriously noisy so I don’t notice the tinnitus too much. I could go on and on, but you get the picture. By the way, I was a healthy active person prior to this reaction, I was 47 at the time and most people would guess my age at 35 because of my personality, strength and agility, they were always shocked to find out how old I was. Please help me in preventing any other healthy individuals from experiencing this nightmare. I also challenge you to do your own research into the real picture of this class of antibiotics, quit taking the word of the FDA or pharmaceutical companies, they have an agenda, but it is less than honorable. You can start by going to www.fluoroquinolones.org . Thank you for your time.Location: Louisiana
If I remember correctly, the FDA said the drug companies had 30 days to respond to the "black box" warning on July 8, 2008 in the news. It has been over 30 days since the news came out about this. Still no "black box" warning on these medicines at our pharmacies. So much for "strict timelines". "Fluoroquinolone manufacturers are required to submit the safety labeling changes" is old news. "Where's the "black box" warnings?" should be the current news. My husband became disabled after taking Cipro