Product Liability

Liver failure, death linked to topical osteoarthritis drug

The Food and Drug Administration (FDA) has notified health care professionals of serious adverse events including liver failure and death linked to a topical NSAID prescribed for the treatment of osteoarthritis. Postmarketing reports indicate that cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with Voltaren Gel (diclofenac sodium topical gel) 1 %. 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.

Voltaren Gel is a registered trademark of Novartis AG and is marketed by Endo Pharmaceuticals Inc. Both companies issued a “Dear Healthcare Professional” letter notifying them of revisions to the prescribing information and additions to the new warnings and precautions section of the drug’s labeling to include the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium.

Physicians are asked to measure transaminases periodically in patients receiving long-term therapy with diclofenac. Clinical trail data and postmarketing experiences indicate that transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac.

Patients with questions should contact their health care provider. Any adverse events with this or any other medication should be reported to the FDA’s MedWatch reporting system at www.fda.gov/Medwatch.