Diclofenac Labeling Adds Warning of Hepatic Risks

Novartis and Endo Pharmaceuticals have revised the prescribing information for pain drug Voltaren to warn of hepatic risks such as liver failure. The prescribing information for all diclofenac-containing products has been updated at the FDA’s request after postmarketing reports of liver toxicity, the companies say in a “dear healthcare professional” letter released with a MedWatch notice. Postmarketing surveillance has turned up reports of severe hepatic reactions, including liver necrosis, jaundice, liver failure, and fulminant hepatitis with and without jaundice, it says. Some of these cases were fatal or led to liver transplantation.
Washington Drug Letter