July 13, 2010 — The rheumatoid arthritis drug leflunomide (Arava; sanofi-aventis) has received a boxed warning about the risk for severe liver injury, the US Food and Drug Administration (FDA) announced today.
The FDA added a boldface warning about severe liver injury to the drug’s label in 2003 but decided to escalate it in light of an agency review this year of adverse event reports associated with leflunomide. The FDA identified 49 cases of severe liver injury associated with the drug, including 14 cases of fatal liver failure, between August 2002 and May 2009, according to an alert sent today from MedWatch, the FDA’s safety information and adverse event reporting program.
Rheumatoid Arthritis Guy has been on Arava for more than a year now. I think it’s time that I start doing some research on inventing that bionic liver!