The antidepressant Serzone, recently pulled off the market in Europe, should be banned here, a consumer advocacy group told the government Thursday citing 11 deaths from drug-caused liver failure.
Serzone “appears to be one of the most dangerous antidepressants marketed,” Dr. Sidney Wolfe of Public Citizen wrote in a petition filed with the Food and Drug Administration.
It’s impossible to predict which patient will get Serzone-caused liver failure, “nor is there any way to guarantee that once diagnosed, patients’ lives can be saved,” he said.
Public Citizen counted 53 cases of liver injury, including the 11 deaths, among Serzone users reported to an FDA monitoring system since the drug began selling in 1994. The FDA estimates its monitoring system counts fewer than 10 percent of the side effects caused by medications.
Antidepressants cause a variety of side effects, but Wolfe contends there are numerous equally effective but safer alternatives to Serzone.
The FDA will seriously consider the petition, said spokeswoman Susan Cruzan.
A spokeswoman for maker Bristol-Myers Squibb Co. did not return a call seeking comment.
Bristol-Myers quit selling Serzone in Europe in January, saying it made the decision because of low European sales, not safety questions. But some foreign regulators cited concern about fatal liver failure at the time, and Wolfe told the FDA that several had been pursuing stronger safety measures.
In 2001, the FDA added its strongest warning possible to Serzone’s label, bold print inside a black box stating that one side effect is potentially fatal liver failure. FDA’s Cruzan would not say if reports of liver damage have dropped since the stricter warning appeared.