updated 3/15/2004 9:00:45 PM ET 2004-03-16T02:00:45

A consumer advocacy group sued the government Monday, seeking to force a ban on sales of the antidepressant Serzone.

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The drug can cause deadly liver failure and is linked to 20 deaths — and it’s impossible to predict which patient is at risk, said the consumer group Public Citizen.

Serzone already has been taken off the market in Canada and Europe, and will quit selling in Australia and New Zealand in May, said Public Citizen’s Dr. Sidney Wolfe.

He first petitioned the FDA to take Serzone off the U.S. market a year ago, but FDA didn’t act. Public Citizen filed suit Monday, asking a federal judge to declare FDA’s delay illegal and force the agency to act to “protect public safety and prevent needless death and injury.”

FDA says warnings are adequate
The FDA is reviewing the issue, said spokeswoman Susan Cruzan.

But the agency has maintained that liver failure is a rare risk adequately managed by warning patients. In 2002, the FDA added to Serzone’s label the agency’s strongest type of warning, one set off by a black box.

Wolfe argues that warnings haven’t helped. He details 55 cases of liver failure, including the 20 deaths, and another 39 cases of less severe liver injury reported to the FDA since Serzone began selling in 1994.

Rather than seeing side-effect reports trickle off as the years pass, as is typical with older medications, the FDA received more reports of liver failure in the 17 months after strengthening the warning than in the five previous years, the lawsuit contends.

The FDA estimates its monitoring system counts fewer than 10 percent of the side effects caused by medications, meaning far more Serzone users may have been harmed, Wolfe said.

The drug works no better than older, safer antidepressants, he added, pointing to a report from the World Health Organization and Health Canada that compared a number of popular antidepressants and found only Serzone linked to serious liver injury.

Serzone maker Bristol-Myers Squibb declined comment on the suit.

Serzone, known chemically as nefazodone, inhibits an enzyme key to drug metabolism, allowing the antidepressant to sometimes build to toxic levels in the liver, Wolfe said. That enzyme also metabolizes numerous other drugs, meaning patients taking multiple medications could be at higher risk, he said.

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