Bristol Myers Squibb Takes Serzone off the market on June 14 – AP

Wed, 19 May 2004

The antidepressant Serzone, TAKEN OFF THE MARKET as of June 14 (for “business reasons” the company says).

The drug was already taken off the market in Europe, Australia, New Zealand and Canada. In the case of Canada, because of “adverse events including liver failure.” However, the company continued to sell the drug in the US.

“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.”

Public Citizen was in the process of suing the FDA the agency had not responded to its petition asking for a ban.on Serzone.

Hundreds more victims and families are suing its maker Bristol Myers Squibb.

CBS news had aired a story of one such victim: Cassie Geisenhof who was just 15 when she was prescribed Serzone for depression.

Three months later, she suffered irreversible liver damage and got a transplant but never recovered. She died last month.

This does 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.

Statement from Bristol Myers:

“For commercial reasons we’re discontinuing sales and manufacture of Serzone effective June 14.We decided to discontinue sales of the product specifically because there’s currently a wide availability of the product through generic companies in the US and we’ve seen a rapid decline of the volume of branded sales.” The company denies adverse events played any role in the withdrawal, even though the company acknowledged that was the case in the Canada withdrawal.

Contact: Vera Hassner Sharav
Tel: 212-595-8974

Maker to pull antidepressant off market
By LAURAN NEERGAARD
The Associated Press
5/19/2004, 4:55 p.m. ET

WASHINGTON (AP) – 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 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 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.

Copyright 2004 The Associated Press. All rights reserved

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