Resources for Food and Drug Administration (FDA)

FDA calls for urgent warning on tendon risks

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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 usually among men in their mid-thirties. 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.

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