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Carol Eustice

Voltaren Gel Adds Warnings About Liver (Hepatic) Effects

By , About.com Guide   December 6, 2009

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Back in October 2007, Voltaren Gel was the first prescription topical treatment for osteoarthritis approved by the Food and Drug Administration. Voltaren Gel, a nonsteroidal anti-inflammatory medication in topical form, was then an exciting new treatment option -- especially for patients who suffer gastrointestinal side effects from oral NSAIDs.

The makers of Voltaren Gel and the U.S. FDA have announced changes to its label -- revisions to the Hepatic Effects section of the Prescribing Information -- regarding the "potential for elevation in liver function tests during treatment with all products containing diclofenac sodium."

Drug-induced hepatotoxicity cases have been reported in the first month of use but can occur at any time during treatment with diclofenac. Severe hepatic reactions including liver necrosis, jaundice, fulminant hepatitis with or without jaundice, and liver failure have been reported in postmarketing reports. Transaminases (liver enzymes) should be monitored on a regular basis for all patients using diclofenac longterm.

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