Published on:

New Luflunomide Warning

The FDA reports that leflunomide received a boxed warning last week about the risk for severe liver injury, the US Food and Drug Administration (FDA) announced today. Leflunomide is a rheumatoid arthritis drug.

Leflunomide has had strong warnings since 2003, but the FDA decided to turn up the warning even further after a review this year of adverse event reports associated with leflunomide. The FDA identified 49 cases of severe liver injury associated with the leflunomide, including 14 reports of fatal liver failure, between August 2002 and May 2009.