FDA Panel Urges Continued Sale of Rheumatoid Arthritis Drug Arava

A U.S. Food and Drug Administration (FDA) advisory panel has recommended that the controversial rheumatoid arthritis drug Arava continue to be sold because its risks for liver damage do not outweigh its benefits in reducing the symptoms and structural damage of the disease.

After reviewing safety data, the agency's Arthritis Advisory Committee unanimously agreed on March 6 that Arava (leflunomide), when used as directed, is a safe and effective drug among the very limited therapies available to treat RA.

The panel's committee's recommendation was supported by data from three long-term Phase III pivotal trials that found that the drug resulted in marked and clinically meaningful improvement in physical function of the rheumatoid arthritis patients who received it.

Arava has been associated with elevations, sometimes significiant, in liver enzymes. The drug comes with a warning for physicians to regularly check for liver damage in their patients who use the drug.

The consumer advocacy group Public Citizen has urged the FDA to ban the drug, claiming that users are six times more likely to have liver failure than with the standard rheumatoid arthritis treatment of methotrexate.

Other sources: Aventis, FDA