FDA Requires Label Changes on Fluoroquinolone Drugs/Serious Risk

The U.S. Food and Drug Administration (FDA) is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated, and to inform consumers of the serious side effects of peripheral neuropathy. This is a type of serious nerve damage, potentially caused by fluoroquinolones, which can occur soon after these drugs are taken, and may be permanent, the FDA said.

The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection.  Some of the approved fluoroquinolone drugs are:  levofloxacin (Levaquin; Janssen), ciprofloxacin (Cipro; Bayer), moxifloxacin (Avelox; Bayer), norfloxacin (Noroxin; Merck), ofloxacin (Floxin), and gemifloxacin (Factive; Cornerstone).

The topical formulations of fluoroquinolones, for use in the ears or eyes, are not known to be associated with this risk.

If a patient develops symptoms of peripheral neuropathy, the fluoroquinolone should be stopped immediately and the patient should be changed to another, non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk.

Peripheral neuropathy is a nerve disorder, which occurs in the arms or legs. Symptoms include pain, burning, tingling, numbness, muscle weakness, or a change in sensation to touch, pain or temperature. Loss of balance and coordination may also occur. This condition can occur at any time during treatment with fluoroquinolones and can last for months or years after the drug is stopped, or even be permanent.

Patients using fluoroquinolones who develop any symptoms of peripheral neuropathy should notify their health care providers immediately.

We will post updates when additional information becomes available. For more information, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

Related Posts