Fluoroquinolone Increases Risk for Permanent Nerve Damage, FDA Warns

Washington, DCThe Food and Drug Administration (FDA) has issued notice that it requires the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to better describe the serious side effect of peripheral neuropathy (PN). This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent.

The risk of PN occurs only with fluoroquinolones that are taken by mouth or by injection. Approved fluoroquinolone drugs include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive). The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk.

In 2012 the FDA announced that it was evaluating the risk of peripheral sensorimotor neuropathy that may arise from the use of fluoroquinolone antibiotics, with a view to changing the labeling if necessary, which it now deems it is.

Fluoroquinolones, including Avelox, Cipro, and Levaquin are associated with an increased risk of tendinitis and tendon rupture.

The FDA has also notified healthcare professionals that a BOXED WARNING and Medication Guide are to be added to the prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use.