FDA has ordered Bristol-Myers Squibb to include a black-box warning on the label of its antidepressant drug Serzone. The new label will advise patients that severe liver failure may occur with use of the drug. Approximately one case of liver failure for every 250,000 to 300,000 patients is reported in the U.S., according to the FDA. However, the agency warns that the number of cases is underestimated because of underreporting.
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