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The maker of Serzone will pull the controversial antidepressant off the U.S. market next month.
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.
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.