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.
Citing similar reactions abroad, the European Union (news – web sites) last year warned patients and doctors about Arava’s toxicity, Wolfe said. He wants the FDA to go further and ban Arava’s sales.
The FDA said it would carefully consider Wolfe’s petition.
A spokeswoman for Arava manufacturer Aventis Pharma said she had not seen the petition and declined comment about liver damage. Lise Geduldig said Arava was “an important therapeutic option” taken by 200,000 people.
The American College of Rheumatology last summer warned doctors to take special care in prescribing Arava, by repeatedly testing patients’ livers for signs of harm.
But it is impossible to predict which patients will be at risk, said Dr. David Yocum of Arizona Health Sciences Center, who recently had an Arava patient die. Yocum is a former scientific adviser to the FDA who joined Wolfe’s call for a ban.
Unlike other drugs that can clear the body shortly after patients swallow a dose, Arava can takes months to dissipate. Yocum said that means there is not much doctors can do if a patient shows signs of trouble.
Yet some insurance companies pay only for Arava, not more expensive newer therapies that do not come with the same risks, Yocum complained.
“I do not believe that the general rheumatologist understands or has any knowledge about these serious and potentially life-threatening complications,” he said.
Rheumatoid arthritis affects about 2 million Americans, the vast majority of them women. It is not the kind of arthritis that plagues the elderly as their joints essentially wear out. Instead, the immune system goes awry and attacks patients’ own cartilage. It typically strikes between ages 25 and 50.
Liver damage is not the only Arava concern, Wolfe said. FDA records show more reports of lymphoma, high blood pressure and a life-threatening autoimmune disorder called Stevens-Johnson syndrome among Arava users compared with methotrexate, he said.