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[IP] Zenapax - FDA Medwatch



FDA MedWatch: Zenapax [daclizumab] associated with increased mort ality in
cardiac transplant study

Date: Thu, 21 Aug 2003 11:13:56 -0400
From: CDER MEDWATCH LISTSERV <email @ redacted>
Subject: FDA MedWatch: Zenapax [daclizumab] associated with increased mort
ality in cardiac transplant study

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA and Roche revised the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and
CLINICAL STUDIES sections of the prescribing information to include
important new safety information describing the increased mortality seen in
a cardiac transplant study and other updated information regarding
hypersensitivity reactions. Other sections of the ZENAPAX labeling impacted
by the addition of the information from the cardiac transplant study have
also been revised.

Read the 2003 MedWatch safety summary, including links to the "Dear
Healthcare Professional" letter and revised, highlighted label, at:

http://www.fda.gov/medwatch/SAFETY/2003/safety03.htm#zenapax
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