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FDA Warns Fluoroquinolone Antibacterial Drugs Can Cause Permanent Nerve Damage

by Chris Nidel | August 23, 2013 | Litigation, Prescription Drugs, Product Liability

The Food and Drug Administration posted its serious concerns about the risk of nerve damage, known as peripheral neuropathy, with fluoroquinolone use by mouth or injection. This risk is associated with fluoroquinolone antibiotics including levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive).

The full text of the FDA’s release can be found here and is included below.

If you or a loved one has suffered from peripheral neuropathy after taking one of these drugs orally or by injection, please Contact Us  to discuss your case.

[Posted 08/15/2013]

AUDIENCE: Family Practice, Infectious Disease, Pharmacy

ISSUE: FDA has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent.

BACKGROUND: The risk of peripheral neuropathy 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.

RECOMMENDATION: Make sure your patients know to contact you if they develop symptoms of peripheral neuropathy. Make sure your patients receive the Medication Guide with every prescription. If a patient develops symptoms of peripheral neuropathy, the fluoroquinolone should be stopped, and the patient should be switched to another, non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

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This post is for informational purposes only and is not legal or medical advice. Prior results do not guarantee a similar outcome.

Chris Nidel
ABOUT THE AUTHORChris Nidel

Chris Nidel is the founding partner of Nidel & Nace. A chemical engineer by training (University of Virginia and MIT), he worked in pharmaceutical process development before earning his law degree at the University of Virginia. He now represents individuals and communities harmed by environmental contamination and toxic exposures.

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Jonathan Nace
ABOUT THE AUTHORJonathan Nace

Jonathan Nace is a partner at Nidel & Nace, where his practice focuses on complex consumer protection, including deceptive food and supplement labeling, insurance misconduct, and data privacy. He has tried cases in state and federal court and argued before federal appellate courts.

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Zachary Kelsay
ABOUT THE AUTHORZachary Kelsay

Zachary Kelsay is an attorney at Nidel & Nace supporting the firm’s environmental and consumer protection practices. He previously clerked for the 23rd Circuit Court in West Virginia and worked in the Maryland Attorney General’s Consumer Protection Division.

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