Maker to Pull Antidepressant Off Market

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Maker to Pull Antidepressant Off Market

By LAURAN NEERGAARD, AP Medical Writer

WASHINGTON - The maker of Serzone will pull the controversial antidepressant

off the U.S. market next month, blaming a decline in sales rather than

concern about a risk of liver failure.

The end to U.S. sales comes after Serzone was pulled off the market in many

other countries, and as maker Bristol-Myers Squibb was under mounting

pressure from lawsuits. Serzone has been linked to dozens of cases of liver

failure and injury, including at least 20 deaths.

A Bristol-Myers spokesman confirmed the decision in an interview Wednesday,

a day after the company notified wholesalers that distribution would end

June 14.

The end to sales " is long overdue, " said Dr. Sidney Wolfe of the consumer

group Public Citizen. " None of the other antidepressants causes liver damage

like this. "

Wolfe last spring sued the Food and Drug Administration (news - web sites)

seeking to force a ban on Serzone. That suit will proceed in an effort to

also end sales of generic versions of Serzone, called nefazodone, Wolfe

said.

An Alabama attorney said he would ask the company and the FDA to go a step

further and recall Serzone, saying that patients shouldn't continue to buy

and use the pills between now and June 14.

" I really think that's a ploy to take the heat off, " said Jere Beasley, an

attorney in Montgomery, Ala., representing 30 families in Serzone lawsuits.

" It's not going to solve the problem. "

Bristol-Myers spokesman Rob Hutchison said that the decision had nothing to

do with safety questions and that the company would continue to vigorously

defend the pending lawsuits.

" We still believe, and I believe the FDA does, too, as well as physicians,

that nefazodone is an important therapeutic option for patients with

depression, " Hutchison said.

Instead, the company is discontinuing Serzone because of rapidly declining

sales after generic competitors hit the market last year, he said. " Our

market share is very small. "

Sales of 16 other very old products also will cease, he added.

Bristol-Myers ended Serzone sales in Europe over a year ago, citing

declining sales. Canadian regulators banned the drug last fall because of

the liver risk. Sales in Australia and New Zealand are about to end, too.

The FDA has received reports of at least 55 cases of liver failure,

including 20 deaths, and another 39 cases of less severe liver injury since

Serzone began selling in 1994. In 2002, the FDA added to Serzone's label its

strongest type of warning about the liver risk, maintaining that liver

toxicity is a rare risk adequately managed by warning patients.

But Wolfe notes that the World Health Organization (news - web sites) and

Canadian regulators last year compared a number of popular antidepressants

and found only Serzone was linked to an increased risk of serious liver

injury.

Canadian authorities said they banned the drug because there was no way to

predict which patients would be at risk for liver failure. Routine liver

tests haven't reduced that risk, they said.