FDA adds “black box” warning label to fluoroquinolone antibiotics

BMJ 2008; 337 doi: (Published 15 July 2008) Cite this as: BMJ 2008;337:a816
  1. Janice Hopkins Tanne
  1. 1New York

    The US Food and Drug Administration has told manufacturers of fluoroquinolones to warn doctors and patients of the raised risk of tendinitis and tendon rupture. The “black box” warning, the most stringent, must be added to drug labels and prescribing information, and manufacturers must also develop a treatment guide for patients.

    These measures, the FDA said on 8 July, would strengthen the existing warnings in the prescribing information for fluoroquinolones. The warnings apply to tablets, capsules, and injectable formulations for systemic use but not to ophthalmic or otic formulations. …

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