The prescribing information for Voltaren Gel and other products containing diclogenac sodium have been updated to include information about the “potential for elevation in liver function tests during treatment with all products containing diclofenac sodium,” according to a notice posted on the Food & Drug Administration (FDA) Web site.
According to the FDA, 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. Cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with diclofenac.
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.
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.
