FDA mandates warnings for fluoroquinolones

MedPage Today (8/15, Smith, 185K) reports the FDA is mandating an update to medication labels and guides for all systemic fluoroquinolones to warn of quick and potentially permanent nerve damage. The peripheral neuropathy problems seem to occur in oral or injectable variants, but not topical formulations. Unless the benefits outweigh the risks, the agency is asking doctors to switch patients to nonfluoroquinolones. Other rare but severe adverse events impacting the cardiovascular, musculoskeletal, endocrine, renal, and central nervous systems have previously been reported with the class.

        Medscape (8/16, Lowes, 187K) reports that around 3.8 million people received injectable versions and 23 million people received oral formulations of gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin in 2011. The FDA finds that nerve damage problems can exist for over a year after patients stop using fluoroquinolones.