Novartis Zelnorm Revised Labeling Includes Diarrhea Warning, Ischemic Colitis Precaution
This article was originally published in The Pink Sheet Daily
Executive Summary
The warning is the first in tegaserod labeling; Zelnorm was approved in 2002 without a warnings section. FDA has received 20 post-marketing reports of ischemic colitis; GSK’s Lotronex was withdrawn in 2000 following 49 reports.
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