Arava (Leflunomide)
Arava is a disease-modifying anti-rheumatic drug (DMARD) which reduces inflammation and slows disease progression of rheumatoid arthritis. It is not chemically related to other DMARDS.
The EMEA (European Medicines Evaluation Agency) issued a public statement on March 12, 2001 regarding Arava (leflunomide) and serious hepatic reactions. Arava, classified as a DMARD (disease-modifying anti-rheumatic drug) is indicated for patients with active rheumatoid arthritis.
When the FDA (U.S. Food and Drug Administration) approved Arava in September 1998, it was heralded as the first new treatment for rheumatoid arthritis in 10 years. The European Union followed with its approval of the drug in September 1999. Approximately 200,000 people have used Arava since it became available.
The statement from the EMEA revealed a total of 296 adverse reports of hepatic (liver) reactions, of which 129 were considered serious. Included were 2 cases of liver cirrhosis and 15 cases of liver failure, of which 9 were fatal. The reported hepatic reactions occurred within six months of when treatment had been started. The EMEA report emphasizes that "confounding factors" existed in many of the cases. Of the reported adverse reactions:
- 78% (101 patients) were treated with other hepatotoxic medications (medications potentially toxic to the liver) along with Arava
- 58% of patients with elevated liver function tests were simultaneously treated with methotrexate and/or NSAIDS (nonsteroidal anti-inflammatory drugs)
- 27% (33 patients) had other risk factors such as history of alcohol abuse, liver function disturbance, acute heart failure, severe pulmonary disease, and pancreatic carcinoma