http://bmj.com/cgi/content/full/324/7342/869/a

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Collections under which this article appears: Adverse drug reactions Rheumatoid Arthritis

BMJ 2002;324:869 ( 13 April )

News

Arthritis drug should be removed from market, says consumer group

Fred Charatan, Florida

In a petition last month to the Food and Drug Administration, Public Citizen, a Washington based consumer watchdog, asked that leflunomide (Arava) be removed from the market.

Leflunomide 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 admissions to hospital 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 to the FDA.

"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 leflunomide and methotrexate, which is an equally or more effective drug for treatment of rheumatoid arthritis, Public Citizen found that over the three years it has been on the market, leflunomide was linked to six times more cases of fatal liver toxicity and 13 times more reports of hypertension than methotrexate, although 6.8 million (5.5 times) more prescriptions were filled for methotrexate than for leflunomide during that time. Also, leflunomide has been associated with 12 cases of Stevens-Johnson syndrome, and methotrexate with none.

Another danger of leflunomide is that it remains in the body 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 Yocum, director of the Arizona Arthritis Center at Arizona Health Sciences Center, who recently ended a tenure as chairman of the FDA's arthritis drugs advisory committee. Dr Yocum said that he agrees the drug should be withdrawn from the market.

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," Dr Wolfe said. "No more patients should be subjected to these risks."

© BMJ 2002
 

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Collections under which this article appears: Adverse drug reactions Rheumatoid Arthritis

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