Medical News: FDA Adds Liver Failure Warning to RA Drug – in Product Alert, Prescriptions from MedPage Today

The FDA has expanded the black box warning to the label of the rheumatoid arthritis drug leflunomide (Arava) to include possible fatal liver damage.

The agency received 49 adverse event reports — including instances of jaundice, coagulopathy, encephalopathy, and 14 fatalities — about the drug from August 2002 to May 2009. Of the patients reporting adverse events, 36 were hospitalized.