Arava

AravaŽ (leflunomide) is a prescription drug manufactured by Aventis Pharma for the treatment of rheumatoid arthritis. Since its approval by the U.S. Food and Drug Administration ("FDA") on September 10, 1998, it is estimated that 1.5 million prescriptions for AravaŽ have been filled in the United States.

On March 28, 2002, the consumer advocacy group Public Citizen petitioned the FDA for the removal of AravaŽ. The petition to the FDA states that, "[f]rom when it was first marketed in late September 1998 through September 2001, AravaŽ has been associated with at least 130 severe hepatic reactions including 56 hospitalizations and 22 deaths, two of whom were patients in their twenties."

Public Citizen's analysis of available AravaŽ data "found not only many cases of severe drug-induced hepatotoxicity, but also large numbers of lymphomas as well as other hematologic, gastrointestinal, and skin reactions serious enough to cause hospitalizations and deaths, and a large number of cases of drug-induced hypertension."

Another danger of the drug is that it remains in body tissues for an extremely long time. Warnings already on its packaging suggest that byproducts could remain in the body for months, so that even if patients stopped taking the drug after an adverse reaction started, the damage could continue to affect patients for months.

Public Citizen compared AravaŽ to Methotrexate, an equally or more effective rheumatoid arthritis treatment, over a 3 year period. During that time period, there were 5.5 times more prescriptions filled for Methotrexate than AravaŽ. AravaŽ was linked to six times more reports of fatal liver toxicity and 13 times more reports of hypertension than Methotrexate. Additionally, with AravaŽ there were 12 cases of Stevens-Johnson syndrome, a life threatening autoimmune disease involving the skin and the mucous membranes, where with Methotrexate, there were none.

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