May 19, 2004 18:02:52

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Anti-Depressant Taken Off Market

WASHINGTON, May 19, 2004

Anti-Depressant Concerns

Cassie Geisenhof died after her body rejected a transplant liver.  (Photo: CBS)

"From a health perspective there is no justification for this drug being on the market."
Dr. Sidney Wolfe
Consumer Advocate

(CBS) Serzone, a controversial antidepressant, is being taken off the American market as by its manufacturer, Bristol-Meyers Squibb, reports CBS News Correspondent Sharyl Attkisson.

The drug was already taken off the market in Europe, Australia, New Zealand and Canada. In the case of Canada, Bristol-Myers acknowledged the reason was "adverse events including liver failure." However, the company continued to sell the drug in the U.S.

"For commercial reasons we're discontinuing sales and manufacture of Serzone effective June 14, A Bristol-Meyers spokesman told Attkisson today. The company denies adverse events played any role in the withdrawal, even though the company acknowledged that was the case in the Canada withdrawal.

The advocacy group, Public Citizen was in the process of suing the Food and Drug Administration over Serzone because the FDA had not responded to the Public Citizen petition asking for a ban.

This will not quite end the controversy, as generic versions of the drug are still on the market and Public Citizen will continue to sue the FDA over this issue if the generics aren't also pulled.

Serzone, the brand name for "nefazodone," is linked to dozens of liver failures including at least 21 deaths in the U.S., reports Attkisson. Hundreds of patients who may have been affected are suing Bristol-Meyers.

Last month, Attkisson reported on one of those possible victims, Cassie Geisenhof, who was just 15 when a doctor prescribed Serzone for her depression.

Three months later, Cassie suffered irreversible liver damage. Doctors rushed her in for an emergency liver transplant and blamed the Serzone.

The FDA forced Bristol-Myers Squibb to add a serious liver warning two years ago, but problems continued.

"Is there any legitimate reason this drug should still be sold in the U.S. when it's been taken off the market in other places for the same dangers?" Attkisson asked Dr. Sidney Wolfe of Public Citizen.

"From a financial perspective, the only reason is to make money for Bristol-Myers Squibb," answered the consumer advocate. "From a health perspective there is no justification for this drug being on the market."

The FDA said it was studying the lawsuit.

Bristol-Myers defended Serzone as "an important therapeutic option." But even the company said it's not the first choice, but for patients "who have not responded to other medication."

Unfortunately, Cassie Geisenhof suffered constant problems after her liver transplant. She lapsed into a coma and passed away on April 13 in a Minneapolis hospital.

©MMIV, CBS Broadcasting Inc. All Rights Reserved.

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