Public Citizen Calls on FDA to Ban Arthritis Drug

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Public Citizen Calls on FDA to Ban Arthritis Drug

Thu Mar 28, 5:20 PM ET

By Richwine

WASHINGTON (Reuters) - The US consumer group Public Citizen on Thursday

urged regulators to immediately ban the rheumatoid arthritis drug Arava

(leflunomide), saying it had linked the product to 12 fatal cases of

liver damage.

Arava's risks outweigh its benefits, which are no better than those

offered by an older, commonly used treatment, Public Citizen asserted in

a petition to the Food and Drug Administration (news - web sites) (FDA).

From September 1998, when Arava debuted in the United States, to

September 2001, the FDA received 130 reports of severe liver problems in

patients taking Arava, Public Citizen claims. For 12 cases that were

fatal, liver damage from Arava " appears to be the most plausible

explanation, " the group said.

Officials at Arava's maker Aventis SA, which reported worldwide sales of

258 million euros ($225 million) for Arava in 2001, were not immediately

available for comment.

Public Citizen said it also found reports of lymphoma and drug- induced

hypertension in people treated with Arava, as well as skin, blood and

gastrointestinal reactions serious enough to cause hospitalization. In

clinical trials, Arava's effectiveness was less than or equal to that of

methotrexate, a drug commonly used to treat the painful and swollen

joints of rheumatoid arthritis, Public Citizen said, adding that fewer

serious reactions have been reported with methotrexate.

Patients also have other treatment options, according to the group. " With

a variety of better drug treatments available, there is no reason to

subject patients to an accumulating list of added risks. [Arava] should

be promptly removed from the market, " the petition said.

Dr. Yocum, director of the Arizona Arthritis Center, also said

Arava should be pulled from the market. One of his patients treated with

Arava and another drug died from liver failure, but he acknowledged that

he was uncertain whether either or both drugs were to blame. He said

insurers pressure him to use Arava if methotrexate does not work because

other options cost more.

Public Citizen's data are " worrisome " because Arava's possible side

effects appear " idiosyncratic and unpredictable, " said Yocum, who

previously headed an FDA advisory panel that reviews arthritis drugs.

Yocum was excluded from the panel's review of Arava because he had taken

part in clinical trials of the drug.

FDA officials were not immediately available for comment.

About a year ago, the European Medicines Evaluation Agency warned that

severe liver reactions--some with fatal outcomes--have occurred in

patients treated with Arava. In a public statement on its Web site, the

agency said a total of 296 liver reactions had been reported by that

time, with 129 cases considered serious and nine having a fatal outcome.

The statement acknowledged that confounding factors were often present,

but said that a relationship to leflunomide could not be ruled out.

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