FDA warns of potential hepatotoxicity with Voltaren Gel

Endo, Novartis, and the FDA have notified healthcare professionals that the Voltaren Gel (diclofenac sodium gel) Prescribing Information has been updated to include new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium. Postmarketing reports of drug-induced hepatotoxicity have been reported in the first month of treatment with diclofenac, but can occur at any time. These reports include cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these cases have resulted in fatalities or liver transplantation.

Healthcare providers should measure transaminases periodically in patients receiving long-term diclofenac therapy. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4–8 weeks after initiating treatment with diclofenac.

Voltaren Gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment (eg, knees, hands).

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm193047.htm.