FDA Strengthens Warnings for Fluoroquinolone Antibiotics

Psychiatric adverse reactions may occur even after just one dose
Psychiatric adverse reactions may occur even after just one dose

The Food and Drug Administration (FDA) has approved class-wide labeling changes for all fluoroquinolone antibiotics to strengthen the warnings related to mental health side effects and the risk for severe low blood sugar, including hypoglycemic coma. Fluoroquinolone antibiotics include moxifloxacin (Avelox; Bayer), delafloxacin (Baxdela; Melinta Therapeutics), ciprofloxacin (Cipro; Bayer), gemifloxacin (Factive; Merus Labs), levofloxacin (Levaquin; Janssen), and ofloxacin

The labeling changes are based on a review of postmarketing adverse event reports found in the FDA Adverse Event Reporting System (FAERS) database and published medical literature. Fifty-six reports of hypoglycemic coma associated with fluoroquinolone use were identified in FAERS from October 1987 to April 2017; most of these patients had risk factors for hypoglycemia. As for psychiatric events, the FDA is requiring that all fluoroquinolone antibiotics include the following 6 adverse reactions: disturbance in attention, memory impairment, delirium, nervousness, agitation, and disorientation. 

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With regard to fluoroquinolone use, healthcare professionals should be aware of the following:

  • There is a potential risk of hypoglycemia associated with use that sometimes may result in coma; elderly patients and those taking oral hypoglycemic agents or insulin may be at increased risk
  • Psychiatric adverse reactions may occur even after just one dose
  • Treatment should be discontinued if patients report any CNS side effects, including psychiatric adverse events, or blood glucose disturbances; switching to a non-fluoroquinolone antibiotic should be considered if possible
  • If serious side effects involving the tendons, muscles, joints, or nerves occur, treatment should be stopped and patients should be switched to a non-fluoroquinolone antibiotic
  • Fluoroquinolones should not be prescribed for acute bacterial sinusitis, acute bacterial exacerbations of chronic bronchitis, and uncomplicated urinary tract infections if patients have other treatment options because the risks outweigh the benefits in these patients

“The use of fluoroquinolones has a place in the treatment of serious bacterial infections — such as certain types of bacterial pneumonia — where the benefits of these drugs outweigh the risks, and they should remain available as a therapeutic option," said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. "The FDA remains committed to keeping the risk information about these products current and comprehensive to ensure that healthcare providers and patients consider the risks and benefits of fluoroquinolones and make an informed decision about their use.” 

For more information visit FDA.gov.