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Zelnorm off the market

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Zelnorm to be discontinued and taken off the market:

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.

Here is a link:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#Zelnorm

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