FDA - MedWatch - Zelnorm (tegaserod maleate)- Product Market Withdrawal - Study Results Showed Patients on Drug Had Higher Risk of Serious Cardiovascular Adverse Events
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals and patients that Novartis has agreed to discontinue marketing Zelnorm, a drug used for the short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years of age with chronic constipation. FDA analysis of safety data pooled from 29 clinical trials involving over 18,000 patients showed an excess number of serious cardiovascular adverse events, including angina, heart attacks, and stroke, in patients taking Zelnorm compared to patients given placebo. Patients taking Zelnorm should contact their healthcare professional to discuss treatment alternatives and seek emergency medical care if they experience severe chest pain, shortness of breath, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke. Healthcare professionals should assess their patients and transition them to other therapies as appropriate.
Read the complete MedWatch 2007 Safety summary, including a link to the FDA Public Health Advisory regarding this issue at:
http://www.fda.gov/medwatch/safety/2...07.htm#Zelnorm