Bristol Serzone Status Unchanged In U.S.; Antidepressant Pulled In Europe
Executive Summary
FDA is comfortable with Serzone's current labeling, the agency said following Bristol-Myers Squibb's decision to pull the antidepressant off the market in Europe
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Bristol has entered discussions with Canadian regulators over the risk/benefit profile and marketing status of its antidepressant Serzone, the company says. Serzone (nefazodone) has been associated with reports of hepatic failure; the company added a "black box" warning to labeling for the antidepressant in 2001 following 18 reports of liver failure, including 13 deaths (1"The Pink Sheet" Dec. 10, 2001, p. 22). Bristol withdrew Serzone from the market in Europe earlier this year (2"The Pink Sheet" Jan. 13, 2003, p. 23)...