FDA zeroes Zelnorm
ROCKVILLE, MD - MedWatch, the Safety Information and Adverse Event Reporting Program of the U.S. Food and Drug Administration (FDA), notified healthcare professionals and patients that Novartis ended marketing Zelnorm, used for short-term care of women with irritable bowel syndrome with constipation or patients younger than 65 with chronic constipation. An FDA analysis of safety data pooled from 29 clinical trials involving more than 18,000 patients showed an excess number of serious cardiovascular adverse events, including angina, heart attacks, and stroke, in patients taking Zelnorm versus patients given placebo. Patients taking Zelnorm should call the doctor to discuss other treatment and seek emergency care if they get severe chest pain, shortness of breath, sudden weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke. Doctors should assess the patient and transition them to other therapies. Read the complete MedWatch summary at www.fda.gov/medwatch/safety/2007/safety07.htm#Zelnorm.