Why did Bristol-Myers warn Canadian physicians half a year before the U.S. of the risks associated to Serzone antidepressant drug?
The Canadian government told Bristol-Myers to send out letters to physicians after reports of deadly cases of liver failure in Serzone antidepressant drug patients was being reported back in June 2001. Bristol-Myers failed to warn U.S. physicians at this time because they claimed it was “specific to Canada.” Finally, in December 2001, the FDA required Bristol-Myers to put the strongest warning the FDA issues, a Black Box warning, on Serzone antidepressant drug labels.
