May 19, 2004 8:13:00 PM ET WASHINGTON, May 19 (Reuters) – Bristol-Myers Squibb (BMY) said on Wednesday it would no longer make or sell its antidepressant Serzone, which has been linked to life-threatening liver problems.
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A company spokesman said the drug, already withdrawn in major markets such as Europe and Canada, was being discontinued worldwide, including in the United States, due to poor sales. The antidepressant is also being withdrawn in Australia and New Zealand. "After review of the commercial potential of several of our mature products, we decided to discontinue manufacturing and selling certain … products, including Serzone," said Robert Hutchison, a spokesman for New York-based Bristol-Myers. Serzone is one of 17 drugs to be discontinued, Hutchison said, adding the halt takes effect June 14.
The controversial drug is the subject of several lawsuits over safety concerns and has been linked to 55 cases of liver failure, including 20 deaths, the U.S. Food and Drug Administration has said. In March, U.S. consumer group Public Citizen sued the FDA in an attempt to force a ban on Serzone. Dr. Sidney Wolfe, head of Public Citizen's Health Research Group, said the Bristol-Myers' action on Wednesday fell short. The company should recall the Serzone already available, and generic versions of the drug should also be recalled, he said. "We strongly urge all people using either Serzone or generic nefazodone to contact their physicians about switching to a safer antidepressant," Wolfe urged. Bristol-Myers' Hutchison said the company would "continue to vigorously defend itself against the implication" that Serzone was not safe. The company's stock fell 6 cents to close at $25.49 on Wednesday on the New York Stock Exchange.