Arthritis Drug May Cause Liver Damage
By LAURAN NEERGAARD
.c The Associated Press
WASHINGTON (March 28) - 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
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
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
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,
''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.