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.
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.
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.
added that, of the 12 cases of fatal liver damage,
leflunomide-induced liver toxicity "appears to be the
explanation," the group said.
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.
of March 31, 2002