Fluoroquinolone FDA Black Box Warning

  • 12/20/2018 – FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients (source)

  • 7/10/2018 – FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes (source)

  • 7/26/2016 FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects (disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. (source)

  • 5/12/2016 – FDA approves safety labeling changes for fluoroquinolones

    FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together (Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations.) (source)

  • 8/15/2013 –FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection (Peripheral Neuropathy) (source)

  • 10/2008 – Warning on Tendon Injuries with Fluoroquinolone Antibiotics – FDA Patient Safety News (source)

  • Subject: Important Changes in the Avelox® (moxifloxacin hydrochloride) and Cipro® (ciprofloxacin) Complete Prescribing Information – New Limitations of Use and Safety Information for Fluoroquinolones

    Dear Health Care Professional:

    Bayer HealthCare Inc. and Merck & Co., Inc. would like to inform you of important changes to the prescribing information for fluoroquinolone antibiotics for systemic use in the United States, including Avelox® (moxifloxacin hydrochloride) and Cipro® (ciprofloxacin).(source)