Public Citizen Urges FDA to Take Arthritis Drug Arava Off the Market

The advocacy group Public Citizen, citing toxicity concerns, has called on the U.S. Food and Drug Admistration to take the arthritis drug, Arava, off the market.

Public Citizen claimed the toxicity of Arava (leflunomide) is "clearly greater than that of methotrexate" – the gold standard in treatment of rheumatoid arthritis -- and said it has been linked to 130 severe liver reactions, 56 hospitalizations and 22 deaths.

The petition stated that although there were 5.5 times more prescriptions filled for methotrexate, there were "six times more reports of fatal liver damage" with leflunomide.

The petition added that, of the 12 cases of fatal liver damage,
leflunomide-induced liver toxicity "appears to be the most plausible
explanation," the group said.

"With a variety of better drug treatments available, there is no reason to subject patients to an accumulating list of added risks. [Arava] should be promptly removed from the market," the group said.

Other sources:Public Citizen