Arthritis Drug Too Dangerous, Group Says
March 29, 2002 -- The rheumatoid arthritis drug Arava should be banned, a consumer watchdog group says.
Arava is linked to 22 deaths in its first three years of approval, according to FDA data obtained by the watchdog group Public Citizen. Twelve of the deaths appear directly due to liver damage from the drug. And that's just the tip of the iceberg -- the deaths were among 130 severe liver reactions, including 56 hospitalizations.
That's not all, says Sidney M. Wolfe, MD, director of the Public Citizen Health Research Group. The drug also is linked to severe high blood pressure resulting in stroke and can cause birth defects. These effects can persist long after a person stops taking the drug, as it stays in the body for months. And normal "wash-out" procedures that remove the drug from the body don't seem to work when patients suffer toxic effects.
"If this were a breakthrough drug that is really saving lives, that would be one thing -- but this is a drug that is no better than safer alternatives," Wolfe tells WebMD.
Wolfe notes that several studies show another drug, methotrexate, to be as effective as Arava.
Wolfe provided WebMD with a letter from David E. Yocum, MD, director of the Arizona Arthritis Center. Yocum recently finished a term as chair of the FDA's Arthritis Drugs Advisory Committee.
"We have lost a patient due to [liver damage] who was on [Arava]," Yocum writes. "In addition, my partner had a patient with acute high blood pressure and a stroke."
Yocum, an internationally recognized expert in arthritis treatment, says there is no way to predict which patients will suffer ill effects from Arava.
"Given the information on such serious adverse events, the apparent inability to predict patients who might suffer from the severe and potentially life-threatening complications, and the apparent ineffectiveness of a wash-out procedure, I support [Wolfe's] view that this agent should be withdrawn from the market," he writes.
Wolfe notes that during the first three years after Arava approval, there were five-and-a-half times more prescriptions written for methotrexate than for Arava. Yet Arava had six times more reports of fatal liver damage and 13 times more reports of high blood pressure. There also were 12 reports of a life-threatening autoimmune disease with Arava, but none with methotrexate.