Zelnorm Off the Market
 

Just got a call from my gastroenterologists office about Zelnorm...

Zelnorm


--------------------------------------------------------------------------------
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