Regulatory

Bristol in talks with Canada over antidepressant

Last Updated: 2003-08-29 10:06:12 -0400 (Reuters Health)

NEW YORK (Reuters) - Bristol-Myers Squibb Co. on Friday said it is discussing the safety of its antidepressant Serzone (nefazodone) with Canadian regulators, but declined to say whether it is on the verge of pulling the medicine from Canadian drugstores.

Due to liver failure among some patients taking the drug, Bristol-Myers has already stopped selling Serzone in Europe - leaving Canada, the United States and Australia as its only remaining major markets.

Rob Hutchison, a spokesman for the New York-based drugmaker, verified that the company was in talks with Health Canada, but declined to speculate on the outcome of the discussions.

Sales of Serzone have already been crimped by a prominent warning about the liver problems on the drug's package insert label, a so-called "black box" warning. The medicine generates about $150 million in annual sales, making it a relatively minor product for a company with yearly revenue of more than $14 billion.

The U.S. Food and Drug Administration has received reports of liver failure leading to death or the need for a transplant. The agency pegs the incidence of liver problems at one patient per 250,000 to 300,000 taking the drug.