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Voltaren Gel Label Updated Over Liver Complications

Dec 7, 2009 | Parker Waichman LLP

Voltaren Gel and other products containing diclogenac sodium have been associated with increases in liver dysfunction, as well as severe  hepatic reactions which have sometimes resulted in  liver transplantation or death.  According to a notice posted on the Food & Drug Administration (FDA) Web site,  the prescribing information for Voltaren Gel has been updated to include information regarding the "potential for elevation in liver function tests during treatment with all products containing diclofenac sodium."

Healthcare providers have been advised that  transaminases (liver enzymes) should be monitored on a regular basis for all patients using diclofenac-containing products long-term.

Voltaren Gel is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.   It has not been evaluated for use on joints of the spine, hip, or shoulder.  It is made by  Novartis AG and marketed by  Endo Pharmaceuticals Inc. in the U.S. under a license agreement with Novartis AG and Novartis Consumer Health, Inc.

According to the FDA, in postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of  these reported cases resulted in fatalities or liver transplantation, the FDA said.

The FDA is advising that physicians measure transaminases periodically in patients receiving long-term therapy with diclofenac. The optimum times for making the first and subsequent transaminase measurement are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac, the FDA said.


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