Drug safety officials Tuesday imposed the government's most urgent safety warning on Cipro and similar antibiotics, citing evidence that they may lead to tendon ruptures, a serious injury that can leave patients incapacitated and needing extensive surgery.
The Food and Drug Administration ordered makers of flouroquinolone 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.
The two leading drugs covered are Cipro, made by Bayer, and Levaquin, made by Ortho-McNeil. Cipro became a household name during the anthrax attacks of 2001. It is stockpiled by the government in case of a bio-terror attack.
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