interesting

[Guest guest]

This was sent to me and I thought it important to pass it along.

Lynn

Here is an interesting article:

http://content.health.msn.com/content/article/1834.50428

Arthritis Drug Too Dangerous, Group Says

Public Citizen Calls for Ban on Arava

By DeNoon </content/article/1756.53105>

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 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this agent should be withdrawn from the market, " he writes.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.

" We have really understated how prevalent these problems are, " Wolfe

says. " This drug will come off the market. Unfortunately it will be too

late for many people who had liver damage or strokes from taking it. "

Arava is manufactured by Aventis.

" Aventis continues to believe that the benefit-to-risk profile for Arava

is positive, " Aventis spokeswoman tells WebMD. " We

encourage all physicians to closely follow all warnings and

recommendations in the product labeling. "

says that the company is aware of reports of adverse events and

is already working with the FDA to put stronger warnings on the Aventis

label. This might include the so-called " black-box " warning that FDA

uses for particularly dangerous drugs.

Wolfe and Yocum say this isn't enough.

" Providing a black box warning concerning these issues may not be

effective since no one can predict who will suffer from these

complications, " Yocum writes. " In addition, I am not sure that frequent

monitoring of the patients with blood chemistries and a complete blood

profile would be effective at preventing them. "

© 2002 WebMD Inc. All rights reserved.