FDA Ups Neuropathy Warning for Fluoroquinolones

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The FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated with the serious side effect of peripheral neuropathy. The nerve damage may occur soon after these drugs are taken by mouth or by injection, and may be permanent.

RELATED CHART: Antibiotic Formulations

The affected fluoroquinolone drugs include: Levaquin (levofloxacin; Janssen), Cipro (ciprofloxacin; Bayer), Avelox (moxifloxacin; Bayer), Noroxin (norfloxacin; Merck), Factive (gemifloxacin; Cornerstone), and Ofloxacin.

Topical formulations indicated for the ears or eyes are not known to be associated with this risk.

The FDA recommends discontinuing the fluoroquinolone if the patient develops symptoms of peripheral neuropathy. The patient should be switched to another, non-fluoroquinolone antibiotic unless the benefit outweighs the risk. Symptoms include pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature, or the sense of body position.

For more information call (888) 463-6332 or visit FDA.gov

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