(dailyRx)

The FDA has notified health care professionals about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium (Voltaren).
Endo Pharmaceuticas and Novartis, the pharmaceutical firms that market Voltaren in the U.S., have updated the medication's "Hepatic Effects" section of its prescribing information to add new warnings and precautions about this side effect. 

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

Physicians should 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 four to eight weeks after initiating treatment with diclofenac.

Voltaren Gel is a nonsteroidal anti-inflammatory drug (NSAID) that can relieve osteoarthritis pain of certain joints, such as the knees and joints in the hands. Voltaren Gel has not been evaluated for use on joints of the spine, hip or shoulder. The full prescribing information for the medication contains guidance about using Voltaren Gel, as well as additional warnings and precautions.

Contact:
FDA
888-463-6332