Fluoroquinolone antibiotics may have serious side effects and should be used sparingly, federal officials warned Tuesday.
Such side effects have prompted the Food and Drug Administration (FDA) to issue label changes for such drugs.
“Fluoroquinolones have risks and benefits that should be considered very carefully,” Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a news release. “It’s important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use.”
Side effects from fluoroquinolones may be “disabling and potentially permanent” and include tendon rupture, muscle or joint pain, neuropathy, depression and hallucinations, according to the FDA. Patients may experience more than one of these effects, which can happen within hours or weeks.
The new warnings instruct doctors to prescribe fluoroquinolones as a last resort for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections, according to the FDA. However, they still may be appropriate for more serious infections like plague or bacterial pneumonia.
The warnings apply to levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin and gemifloxacin (Factive), which already carry boxed warnings and other precautions.
Patients should contact their doctor if they experience side effects like unusual joint pain, muscle weakness, numbness or hallucinations.
Health care professionals and patients can report adverse side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report or by calling 800-332-1088.
