The FDA has notified healthcare professionals in the US of revisions to the ‘hepatic effects’ section of the prescribing information for diclofenac sodium topical gel (Voltaren® Gel), to include new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac.

In postmarketing reports, cases of drug-induced hepatotoxicity, including severe reactions such as liver necrosis, jaundice, fulminant hepatitis, and liver failure, have been reported in the first month, but can occur at any time during treatment with diclofenac.  Some of the reported cases resulted in fatalities or liver transplantation.

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