to Pull Antidepressant Off Market
by Lauran Neergaard, The Associated Press, May 19, 2004
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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
"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
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
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