FDA slaps a warning on Cipro, other drugs
The Food and Drug Administration ordered makers of fluoroquinolone drugs — a potent class of antibacterials — to add a prominent "black box" warning to their products and develop new literature for patients emphasizing the risks.
Tendon ruptures are normally thought of as sports injuries, generally occurring among men in their mid-30s. The link to treatment with the antibiotics is highly unusual, and scientists still don't fully understand why it happens. However, FDA officials stressed that many of the serious injuries appear to be preventable if patients stop taking the drug at the first sign of pain or swelling in a tendon, call their doctor and switch to another antibiotic.
The two leading drugs covered by the warning are Cipro, made by Bayer, and Levaquin, which is made by Ortho-McNeil. Cipro became a household name during the anthrax attacks of 2001. It is effective against that deadly bacteria and is among the drugs stockpiled by the government in case of a bio-terror attack. In everyday medicine, Cipro is often used to treat urinary tract infections. Levaquin is generally used to treat respiratory infections. The FDA warnings do not apply to fluoroquinolone drops used to treat eye infections.
FDA officials pointed out that prescribing literature for the drug class already carried clear warnings of the risk of tendon rupture. They said the agency acted to emphasize the warnings because continued reports of injuries indicated that the message may not have gotten through to doctors and patients.
"The continued reports demonstrate additional steps are warranted to better manage the risk of tendon rupture," said Renata Albrecht, director of an FDA office that focuses on unusual microbes.
FDA officials said they had received several hundred reports of tendon ruptures but would not cite a specific number. Wolfe, of Public Citizen, said the number was 407 at the end of 2007, with another 341 reports of tendinitis. He continued to criticize the agency, saying it should also require drugmakers to send individual letters to doctors about the risks. FDA officials said manufacturers could choose to send such letters on their own.
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In the last 4 years I have taken alot of Cipro because it is the...
Audrey | July 10, 2008 at 8:40 a.m.
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