FDA urged to ban arthritis drug

Consumer advocacy group cites liver failure, deaths

ASSOCIATED PRESS

March 28, 2002

WASHINGTON, — A prescription drug for rheumatoid arthritis has been linked to dozens of serious liver injuries and 12 deaths and should be banned, a consumer advocacy group told the government Thursday.

ARAVA BEGAN selling in 1998 as a competitor to the gold-standard treatment for rheumatoid arthritis, called methotrexate. When the Food and Drug Administration approved Arava, the agency noted Arava worked no better than the older drug, but said patients needed some different options.

Since then, the FDA has received at least 130 reports of severe liver toxicity linked to Arava use, including 56 hospitalizations and 12 deaths, said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen.

Two of the deaths were people in their 20s.

Since Arava and methotrexate work equally well, and methotrexate also bears a warning about possible liver damage, Wolfe compared the two. The FDA has six times more reports of liver damage among Arava users than methotrexate users — even though thousands more people use methotrexate, he said.

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