Novartis Zelnorm Revised Labeling Includes Diarrhea Warning, Ischemic Colitis Precaution

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 FDA has received 20 post-marketing reports of ischemic colitis; GSK’s Lotronex was withdrawn in 2000 following 49 reports.