FDA Public Service Release
7/8/2008 - Antibiotics known as fluoroquinolones will need to carry a black box warning alerting physicians to the increased risk of tendonitis and tendon rupture associated with their use, the U.S. Food and Drug Administration said Tuesday.
This risk is greatest among people over 60; in kidney, heart and lung transplant recipients; and among those taking steroids, the agency said.
The FDA is also asking doctors to advise their patients that if they have any sign of tendon pain and swelling or inflammation, they should stop taking the drugs immediately. Patients also should avoid exercising the affected area and contact their doctor immediately.
Tendon rupture can occur during or after taking fluoroquinolones, which include Cipro. Cases of tendon rupture have been reported up to several months after completing fluoroquinolone therapy, according to the FDA.
The drugs affected by the warning include: ciprofloxacin (marketed as Cipro and generic ciprofloxacin); ciprofloxacin extended release (marketed as Cipro XR and Proquin XR); gemifloxacin (marketed as Factive); levofloxacin (marketed as Levaquin); moxifloxacin (marketed as Avelox); norfloxacin (marketed as Noroxin); and ofloxacin (marketed as Floxin and generic ofloxacin).
The FDA is also notifying makers of fluoroquinolones that they need to develop and distribute a medication guide for patients, alerting them to the possible side effects.
"All the currently marketed fluoroquinolones contain warnings regarding the risk of tendon-related adverse events, including the risk of tendon rupture," Dr. Edward Cox, director of the Office of Antimicrobial Products at the FDA's Center for Drug Evaluation and Research, said during an afternoon teleconference. "The new language will strengthen the existing warnings."
"Despite the current warning information on tendon adverse events and tendon rupture, the FDA continues to receive a considerable number of reports of tendon-related adverse events," Cox said. "The FDA believes the new labeling changes will better inform health-care providers and patients about the risk of tendon rupture."
Makers of fluoroquinolones are required to submit the changes to the label to the FDA within 30 days, Cox said.
Dr. Renata Albrecht, director of the Division of Special Pathogen and Transplant Products at FDA's Center for Drug Evaluation and Research, said the ruptures "occur most frequently in the Achilles' tendon."
Achilles' ruptures associated with fluoroquinolones are three to four times more frequent than ruptures among people not taking these drugs, Albrecht said. In the general population, the rate of tendon ruptures is about one in 100,000, she noted.
Signs and symptoms of tendon rupture can include a snap or pop in a tendon area, bruising after an injury in a tendon area, inability to move the affected area or bear weight, the agency said.
The FDA said pain, swelling, inflammation, and tears of tendons -- including the Achilles, shoulder, hand, or other tendons -- can happen in patients taking fluoroquinolone antibiotics. Tendons are the areas that connect muscles to joints.
Prior to requesting the black box warning, the FDA had been sued by the consumer group Public Citizen for ignoring "long-standing evidence" that fluoroquinolones can cause tendon ruptures. The consumer group had been calling upon the agency to add such a warning since 2006.
In January, Public Citizen said that from November 1997 through December 2005, the FDA had received 262 reports of tendon ruptures among fluoroquinolone users. Most involved ruptures of the Achilles' tendon. The group also cited hundreds of additional cases of tendonitis and other tendon disorders.
Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones don't treat viral infections such as colds or the flu.
After Tuesday's announcement, Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, said the black box warning accomplishes two of the three steps that Public Citizen has urged the FDA to take for nearly two years.
But, he added in a news release, "The FDA is silent on our request that it also send a warning letter to physicians clearly describing possible adverse reactions, such as tendon pain, so that patients can be switched to alternative treatments before tendons rupture."
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Comments: 13
David T. Fuller
Director
Fluoroquinolone Toxicity Research Foundation
www.fqresearch.org
fqresearch@aol.com
davidtfull@aol.com
Being a part of the medical community myself, I am very aware of how often this antibiotic is prescribed. I would like to urge physicians to look at their hospital's antibiogram and pick a less toxic and just as effective antibiotic when treating their patients and leave the quinolone class for only life and death situations where no other antibiotic has been effective. Treat it like Vancomycin, which is only used when there is no other choice. There are so many side effects that quinolones cause that go unreported because the connection between the adr and the quinolone is not made.
If the true statistics were reported and made available I believe everyone, but those of us that already aware, would be shocked and these antibiotics would become everyone's last choice.
As for the rest of us, I guess we need to include NO CIPRO! in ut standard medical instructions!
The fact that Cipro and quinolones can cause permanent, untreatable tendon damage as highlighted by the need for a black box warning, that leaves patients with crippling untreatable pain, is only the tip of the iceberg when it comes to the other severe and permanently disabling adverse reactions that Cipro and other quinolones can inflict. The product information sheets provided by quinolone manufacturers fail to indicate that some individuals will suffer from multiple adverse reactions that will become permanent and untreatable. They list a wide variety of adverse reactions that would seriously impair anyone's quality of life, psychological, neurological as well as physical, if one had to live with only a few of them for life. Some of these reactions can develop days, weeks or months after taking these pills as well, making if more difficult to identify the drugs as the culprit of the disease.
I as well as numerous other individuals, who have tried to report these reactions to their physicians and the FDA, have been 'ignored' or 'rebuffed'. I have a 'constellation' of symptoms from taking Cipro in 2006 that do not respond to treatment. My permanent adverse reactions include tinnitus, hyperacusis, visual distortions and light sensitivity, smell and taste perversion, insomnia, anhedonia, chronic fatigue, anxiety and severe depression, loss of appetite, peripheral neuropathy, hypertension, hyperlipidemia, hypothyroid, brain fog, memory problems, constipation and 25 pounds of weight loss in addition to the muscular and degenerative bone issues. Tendonitis is a small part of the entire picture. If you find this hard to believe, check the ADR lists for Cipro and Levaquin. They're all listed, but are considered "rare" reactions. Only tendon damage and peripheral neuropathy are indicated as possible permanent adverse reactions. What I and many others dispute is how "rarely" they occur, and we report that many of these adverse reactions cannot be treated and remain permanent long after taking the drugs. And when people report that they do occur after taking Cipro, or Levaquin, doctors are reticent to admit they were caused by the drugs, especially if they develop in these 'constellation' of maladies.
I feel sick every day, every minute of every day since July 2006. This is consistent with many of the reports of other individuals who took these quinolone drugs and experienced these 'constellations' of reactions that remain permanent till this day. My condition has deteriorated over these past years and continues to do so. No doctor has been able to treat any of my symptoms, let alone explain why they happened all at once.
If Cipro can damage tendons, it certainly can damage other organs and muscles…which is why so many quinolone sufferers report a constellation of symptoms - because this class of drugs has the potential to cripple every system in the body, physiologically, neurologically and psychologically. There is a compilation of evidence at www.fqresearch.org, which should be reviewed by the FDA and medical profession. We hope that eventually the FDA will reexamine their data, that people will be taken seriously when they report these symptoms, that there will be stronger warnings as to the other permanent side effects of Cipro and related drugs, and that serious research efforts will begin to determine why this class of antibiotics are so damaging to some individuals, so others will not be injured.
Contact me at dbcipro 'at' yahoo.com
Leave a comment on my weblog http://deathbycipro.wordpress.com
Thank you.
After my very first dose of cipro I had a cascade of symptoms that I never experienced in my life before such as; Bilateral Achilles tendinitis, Tendinitis in both wrists, Chronic insomnia where it would take 5 hours to fall to sleep then I would be waking up every 1 hour and this continued for 4 months. What is interesting is that I have never had insomnia in my life before cipro. I also experienced chronic nightmares, moderate peripheral neuropathy (burning, tingling, numbness), constant body tremors, dry eyes, dry mouth, dry skin, pulsating sensation in my stomach/neck/hands, pulsatile tinnitus, tinnitus (4 noises), muscle pains, joint pains. Eye flashes, blurry vision, eye floaters, static/snow vision, inability to adjust from light to dark (right eye), twitching, dizziness, stiff neck, head pressure, eye pain, ear pain, difficulty swallowing, aspiration, GERD, lack of appetite. I also had massive increase in spider veins, nail ridges, constant wrinkled fingers, nail growh abnormalities... and my skin become thinner around my body (breakdown of collagen?).
It has been 9 months now since I had my reaction and I still cannot function properly because of my tendinitis... about 80% of my symptoms have lessened or have now gone away. I am improving at a very slow and frustating rate. How can I go from being extremely healthy and having just a minor infection to not being able to function and feeling like I had aged 50 years in one night. I have lost thousands of pounds in earnings and have not been able to work consistently since my reaction.
I have seen literally thousands of people in the same position as me, a significant portion of them were healthy and young like me, and now are disabled. How can the true devestation of this class of antibiotics be revealed if things like tendon damage does not show for months after the last dose? I feel the numbers reported are probably very small because people are not associating antibiotic use with tendon problems, and other problems as I mentioned above. From the moment I took the antibiotic I had a cascade of symptoms that never stopped showing up until about 4 months post-cipro. From there I healed from most of it but now have several injuries which are likely to be with me for life, or until medicine can fix them. I just want my life back, and for doctor to prescribe quinolone drugs when only absolutely needed
Diagnosed w/ arthralgia, trigeminal neuralgia, tendinitis both elbows, enlarged lymph nodes…
still seeing doctor after doctor, and specialists who can only treat the "symptoms", not the cause.
The Black-Box warning for tendon damage is hardly sufficient and long-overdue.
The poisons that robbed my children of a mother were AVELOX and LEVAQUIN…20 pills. I traded a sinus infection for this life of pain and misery.
~Shells~
The medical community simply does not acknowledge the danger of fluoroquinolones. In 6 months of going from specialist to specialist, no one could tell me what was wrong with me because nobody is looking for ADRs to drugs in their diagnostic paradigm. And because they're not, people are being mis-diagnosed.
I feel this is nothing short of a health crisis in this country. These drugs are causing major damage to people and incur great cost to our health care system. In my case, I had probably 30K worth of useless tests. Chronic Fatigue Syndrome and Fibromylgia are possible results of fluoroquinolone ADRs. I know that FQ ADRs mimic arthritis in older people. FQs have been known to cause diabetes. And the list goes on.
Black box warnings should include the FULL SPECTRUM of the ADRs assocoated with these drugs. The FDA is only cutting their losses with this warning in response to a lawsuit by Public Citizen. The FDA should insist on Dear Doctor letters in the USA like there are in Europe. But the FDA is not protecting the citizens of this country; that much is evident. The FDA has ignored evidence of the damage these drugs cause for at least 25 years.