March 28, 2002

Arthritis Drug Should Be Removed From Market

Arava Linked to Liver Complications and Deaths, Public Citizen Tells FDA

WASHINGTON, D.C. - A prescription arthritis drug has been linked to an alarmingly high number of severe liver problems, including deaths, since it came to the market in 1998 and should be taken off the market immediately, the consumer group Public Citizen said today in a petition to the Food and Drug Administration (FDA).

Arava, also known as leflunomide and produced by Aventis, was first marketed in the United States in September 1998 to treat rheumatoid arthritis. Over the next three years, it was associated with at least 130 cases of severe liver toxicity, including 56 hospitalizations and 12 deaths, according to FDA data. Two of those who died were in their 20s.

"To have this many deaths and severe reactions over such a short time is truly disturbing." said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, which submitted the petition. "When there are other treatments that are more effective and don't endanger patients as much as this drug, there is absolutely no reason for the FDA to keep Arava on the market."

In a comparison between Arava and methotrexate, which is an equally or more effective drug for treatment of rheumatoid arthritis, Public Citizen found that over the three-year period it has been on the market, Arava was linked to six times more cases of fatal liver toxicity and 13 times more reports of hypertension than methotrexate, although there were 6.8 million (5.5 times) more prescriptions filled for methotrexate than Arava during that time. Additionally, Arava has been associated with 12 cases of the life-threatening autoimmune disease Stevens-Johnson Syndrome, and methotrexate with none.

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 the drug after an adverse reaction started, the damage could continue to affect patients for months.

Public Citizen's petition is supported by Dr. David E. Yocum, director of the Arizona Arthritis Center at Arizona Health Sciences Center, who recently ended a tenure as chair of the FDA's Arthritis Drugs Advisory Committee. Yocum said he agrees that the drug should be withdrawn from the market.

"I do not believe that the general rheumatologist understands or has any knowledge about these serious and potentially life-threatening complications," Yocum said in a letter to Wolfe. "I also agree that providing a black box warning concerning these issues may not be effective since no one can predict who will suffer from these complications."

Yocum has recently reported to the FDA the death of one of his patients from acute liver failure after using Arava.

After similar serious reactions to leflunomide in Europe, the European Agency for the Evaluation of Medicinal Products issued an urgent warning last year to patients and doctors about the drug's toxicity.

"Before it was approved by the FDA, there was evidence that leflunomide led to liver complications, and now the dangers are even clearer," Wolfe said. "No more patients should be subjected to these risks."

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