FDA Warns of Risk for Permanent Nerve Damage from Fluoroquiniolone Antibiotics
Posted: 16 Aug 2013 10:04 AM PDT
On August 16, 2013, FDA posted a Drug Safety Communication warning the public of the potential risk for permanent nerve damage in patients taking fluoroquinolone antibacterial drugs. FDA has mandated that all fluoroquinolone drug labels and medication guides be updated to properly reflect the risk for peripheral neuropathy.
Fluoroquinolone antibiotics are antibacterial drugs indicated for the treatment of mild-to-moderate infections caused by susceptible bacteria. These drugs work by disrupting the replication of bacterial DNA. FDA-approved fluoroquinolones include ciprofloxacin (Cipro), levofloxacin (Levaquin), gemifloxacin (Factive), moxifloxacin (Avelox), norfloxacin (Noroxin), and ofloxacin (Floxin). FDA stated that the warning of peripheral neuropathy applies to oral and injection formulations of fluoroquinolone antibiotics, and that topical preparations have not been show to pose such risk to patients.
Peripheral neuropathy is displayed through symptoms including pain, burning, tingling, numbness, weakness, or alterations in sensation to touch or temperature. FDA stated that these symptoms may occur at any time during Fluoroquinolone treatment, and these effects could last for multiple years or become a permanent condition.
In 2004, FDA added the risk of peripheral neuropathy to the Warnings section of all Fluoroquinolone drug labels. The agency decided to more thoroughly describe this risk, as the FDA’s Adverse Event Reporting System (FAERS) continued to receive reports of this adverse event. Cases of disabling peripheral neuropathy were reported to the FDA between 2003 and 2012, and the onset of these events was generally rapid (within a few days of treatment initiation).
FDA is continuing its investigation into the risk of peripheral neuropathy, though the agency has not yet identified any particular risk factors associated with the development of this adverse event.
Analysis:
Fluoroquinolone antibiotics (brand names Cipro, Levaquin, Factive, Avelox, Noroxin, and Floxin) are indicated for the treatment of infections caused by susceptible strains of bacteria. Fluoroquinolones are broad-spectrum antibacterial drugs that prevent duplication of bacterial cells.
Using FAERS data (from 11/01/1997 to 08/27/2012), aggregated and standardized by the AdverseEvent RxFilter process, we identified 817 cases of peripheral neuropathies where fluoroquinolones were indicated as the primary suspect. Of these reports, 201 resulted in patient disability.
