Fw: MedWatch - Serzone (nefazodone HCl) associated with rare cases of liver failure

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----- Original Message ----- From: MEDWATCH Sent: Wednesday, January 09, 2002 3:37 PM JUSTINE RENE Subject: MedWatch - Serzone (nefazodone HCl) associated with rare cases of liver failure MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramFDA and BMS added a Black Box Warning and strengthened the WARNINGS,CONTRAINDICATIONS, and PRECAUTIONS sections of the label for Serzone, anantidepressant drug. Rare cases of liver failure leading to transplantand/or death in patients have been reported. A new Patient Package Insert isprovided in the product packaging. For more information, including therevised label, PPI, and Dear Healthcare Professional letter, go to theMedWatch 2002 Safety Information page athttp://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#serzon---------------MedWatch is your Internet gateway for timely safety information on drugs andother medical products regulated by the U.S. Food and Drug Administration.Visit the MedWatch web site regularly for the latest official safetyinformation, at http://www.fda.gov/medwatchTo unsubscribe from the MedWatch e-list service, write an e-mail addressedto:medwatch@...Enter the word "unsubscribe" (no quotes) in the subject line. Please leavethe message body blank and send. The above address is for e-list subscribingor unsubscribing only -- comments or questions about MedWatch should bedirected to the MedWatch web site athttp://www.fda.gov/medwatch/feedback.htm