Aventis Pharmaceuticals and the FDA recently updated the prescribing information for Arava (leflunomide), indicated for the treatment of active rheumatoid arthritis. In post marketing experience, serious hepatic injury, including cases with fatal outcome, have been reported during the treatment with Arava.
What’s the problem?
When the U.S. Food and Drug Administration (FDA) approved Arava in September 1998, it was heralded as the first new treatment for rheumatoid arthritis in a decade. The European Union (EU) followed with its approval of the drug in September 1999. Approximately 200,000 people have used Arava since it first became available.
When the FDA first approved Arava, the agency noted it worked no better than its competitor methotrexate, but it provided more options to patients. Sidney Wolfe, director of the consumer advocacy group Public Citizen, compared the two arthritis drugs and found that FDA records show more reports of lymphoma, high blood pressure, and the life-threatening autoimmune disorder Stevens-Johnson syndrome in Arava patients than methotrexate patients. There have been 6.8 million more prescriptions filled for methotrexate than Arava, but still the number of adverse effects remains higher in leflunomide users. The death rate in Arava users is 33 times higher. Additionally, Wolfe found significantly higher reports of liver damage in Arava patients than in methotrexate patients.
Arava Liver Damage Symptoms
Liver damage from Arava is rare but serious, and suggested patients be on the lookout for the following symptoms of Arava liver problems:
- Yellow eyes or skin
- Dark urine
- Loss of appetite
- Light-colored stools