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Stronger Fluoroquinolone Warning Label

Darrell Hulisz, RPh, PhamD
Eric Stack

August 29, 2013

The US Food and Drug Administration (FDA) has recently announced mandatory label and Medication Guide alterations for the entire fluoroquinolone antibiotic class of medications, such as ciprofloxacin. This requirement is due to the potential of peripheral neuropathy, which can occur shortly after initiation of therapy or at any point during the treatment regimen. The peripheral neuropathy can possibly lead to effects lasting months or years, and possibly result in permanent nerve damage. The risk of peripheral neuropathy is associated with the oral and injection products, not the topical ear or eye formulations. In 2004, the FDA required the risk of peripheral neuropathy to be included in the "Warnings" or "Warnings and Precautions" section of both the oral and injection fluoroquinolone labels, as well as the Medication Guide for the patient. Due to a recent analysis of the Adverse Event Reporting System (AERs) database regarding reports dated between January 1, 2003 and August 1, 2012, the FDA decided that the current labeling did not sufficiently described the problem of the potential adverse effect of peripheral neuropathy. This is partly due to the fast onset of peripheral neuropathy in addition to ongoing symptoms despite discontinuation of the fluoroquinolone.

Currently, if peripheral neuropathy occurs, it is recommended to immediately stop the fluoroquinolone and switch it to a different class of antibiotics unless the benefit of continuing therapy outweighs the associated risk. Symptoms of peripheral neuropathy include pain, burning, tingling, prickling, numbness, and/or weakness in the extremities. Additional symptoms include an alteration in the sensation of touch, temperature, and/or pain in the extremities. However, there have not been any identified risk factors associated with patients on fluoroquinolone therapy and developing peripheral neuropathy, such as age or duration of therapy.

Additionally, the FDA recommends for healthcare practitioners to report peripheral neuropathy and any other adverse effects of fluoroquinolones to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

1. U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by. August 15, 2013. http://www.fda.gov/downloads/Drugs/DrugSafety/UCM365078.pdf.

2. U.S. Food and Drug Administration. Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly permanent nerve damage..

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