Antidepressant Not Available
Sales of the antidepressant nefazodone (Serzone®) were scheduled to cease as of June 14, 2004, according to Bristol-Myers Squibb, the drug’s manufacturer. Generic sales of versions of the drug will continue. However, the watchdog group Public Citizen is suing the FDA to ask that all versions of the drug be taken off the market.
Serzone® and its generic equivalents appear to unpredictably cause serious, sometimes fatal, liver damage in some patients. The product must carry a “black box” warning on its label mentioning the potential for life-threatening liver damage. Short of an outright ban, this is the FDA’s strongest message on the drug’s health risks to consumers.
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The FDA has received reports of at least 55 cases of liver failure, including 20 deaths. Serzone® has been available since 1994.
