Why did the FDA issue a Black Box warning be put on the label of Serzone antidepressant drug?
The FDA ordered that Bristol-Myers include the strongest type of warning possible, a Black Box warning, on the label of Serzone antidepressant drug in December 2001 because of the Serzone liver damage cases. The black box name is referring to the thick black outline that surrounds the warning on the label. The warnings included the information that transplant and/or death can occur due to the liver failure instances. January 2002, the label information for Serzone antidepressant drug was revised once again strengthening the warnings, contraindications, and precautions sections as Serzone liver failure continued to be reported.
