Fluoroquinolone labels updated to reflect peripheral neuropathy risk
FDA: Fluoroquinolones May Cause Irreversible Nerve Damage
HealthDay News -- The FDA is requiring drug labels and medication guides for fluoroquinolone antibacterials be updated to better describe the risk for permanent serious nerve damage due to peripheral neuropathy.
The risk for peripheral neuropathy is only associated with fluoroquinolones taken orally or by injection, the agency stated in a Drug Safety Communication. There is no known risk associated with formulations applied topically to eyes or ears.
Approved fluoroquinolone drugs include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin) and gemifloxacin (Factive).
"Make sure your patients know to contact you if they develop symptoms of peripheral neuropathy," the FDA advised.
All patients prescribed a fluoroquinolone should receive a Medication Guide with every prescription, the agency stated.
If a patient develops symptoms of peripheral neuropathy, the fluoroquinolone should be stopped, and the patient should be switched to another non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk.
Healthcare providers should report adverse events or side effects associated with these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.