RA Drug’s Warning Label Expanded To Include Possible Fatal Liver Damage.

NEWS: Medpage Today(7/13, Petrochko) reported, "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 decision was made after 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." The "greatest risk occurred in patients taking other drugs that may cause liver damage while taking leflunomide and in patients with preexisting liver disease."

Notably, the "drug label already features a boxed warning stating that leflunomide is contraindicated for pregnant women and for women of childbearing potential not using reliable contraception," Medscape (7/13, Lowes) reported. "More information on today's FDA announcement about leflunomide is available on the agency's website