Group Urges Ban of Antidepressant Serzone
Group Urges Ban of Antidepressant Serzone
source: Associated Press Health News
WASHINGTON – The anti-depressant 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.
Cases of liver failure among Serzone users are very rare and “we don’t know why they’re happening,” said Rob Hutchinson, a spokesman for manufacturer Bristol-Myers Squibb Co. But he said rates of liver problems have not changed over the years, suggesting no need for renewed concern.
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.
Wolfe said Serzone inhibits an enzyme key to drug metabolism, allowing the anti-depressant to build to toxic levels in the liver. That enzyme also metabolizes numerous other drugs, meaning patients taking multiple medications could be at higher risk, he said.
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.
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