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Company Pulls Antidepressant Off Market

May 20, 2004 — Sales of the antidepressant Serzone will stop June 14, the drug’s manufacturer says.

Generic sales of versions of the drug — nefazodone — will continue. However, the watchdog group Public Citizen is suing the FDA to demand that all versions of the drug be taken off the market.

Serzone and its generic equivalents unpredictably cause serious, sometimes fatal liver damage in a small number of patients. The drug must carry a “black box” warning on its label warning of life-threatening liver damage and recommending that doctors advise patients to be aware of liver problems. Short of an outright ban, that’s the FDA’s strongest health-risk message to consumers.

But Serzone maker Bristol-Myers Squibb says the safety issues have nothing to do with its decision to stop selling the drug.

“Sales have dramatically declined, so we decided it no longer has commercial viability,” BMS spokesman Rob Hutchison tells WebMD. “The company still believes that prescribing doctors feel the drug has a role to play in the treatment of depression.”

Hutchison says that Bristol-Myers Squibb is also stopping sales of 16 other “mature products.”

Public Citizen, however, suggests that part of the company’s motive may be “massive litigation against the company.” The group says Serzone sales totaled more than $100 million in 2003. It says that it is “irresponsible” of Bristol-Myers Squibb not to issue a recall of the drug. And it worries that injuries will continue via generic sales of nefazodone.

In a news release, Public Citizen vows to continue its lawsuit to force the FDA to act on its year-old petition to ban the drug.

Posted by: Dr.Health

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