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toxic neuropathy

FDA Panel Seeks Tougher Antibiotic Labels

Mounting evidence of previously unknown, and sometimes permanent, side effects prompted review by a Food and Drug Administration advisory panel of widely prescribed antibiotics called fluoroquinolones. In early November 2015, more than 30 individuals spoke at an open public hearing about their own experiences with these effects, many saying they had lost years of their lives. These adverse effects have been seen in a larger number of patients since the FDA approved fluoroquinolone drugs. The panel was asked to consider whether the current labels adequately explain the benefits and risks for the three conditions (sinus infections, urinary-tract infections and bronchitis that worsens existing chronic obstructive pulmonary disease) and, if not, whether the labels should be revised. The panel voted for stronger label warnings about the risks for serious adverse cases, including tendinitis and tendon rupture, prolongation of the QT interval, and peripheral neuropathy. Fluoroquinolones currently approved for one or more of theses illnesses are ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin, and gemifloxacin (generic names).

The FDA now urges companies to make warnings about side effect more prominent in labels so that both patients and doctors are informed about possible risks. READ MORE

Source: The Wall Street Journal