Arthritis Drug May Cause Liver Damage, 12 deaths, 130 reports of severe liver toxicity

March 31, 2002

MEDLINEplus: Arthritis Drug May Cause Liver Damage-

http://www.nlm.nih.gov/medlineplus/news/fullstory_6842.html -

Arthritis Drug May Cause Liver Damage

Associated Press

By LAURAN NEERGAARD AP Medical Writer

Thursday, March 28, 2002

WASHINGTON (AP) - 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 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.

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Arthritis Drug May Cause Liver Damage, 12 deaths, 130 reports of severe liver toxicity

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