Zelnorm Information - September 7, 2008

Novartis' Drug For IBS Taken Off The Chinese Market

June 11, 2007 - Topics diarrhea, zelnorm, pharmaceutical, blood and food
China's State Food and Drug Administration on Friday banned the domestic production and marketing of Zelnorm, a drug used for the short-term treatment of irritable bowel syndrome. The decision comes less than three months after the U.S. Food and Drug Administration asked Novartis Pharmaceuticals Corporation, sponsor of Zelnorm, to stop selling the drug in the United States.

According to Chinese officials, nearly 100 reports of adverse effects caused by Zelnorm have been received in the past four years. Most of the patients reported diarrhea and nausea. Isolated cases of abnormally fast heartbeat low blood pressure also emerged

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Novartis Pulls Constipation Drug Linked To Increased Risk Of Heart Disease

March 30, 2007 - Topics disease, heart disease, fda, cardiovascular and stroke
The U.S. Food and Drug Administration (FDA) has requested Swiss pharmaceutical maker Novartis AG to stop marketing of Zelnorm, a drug to relieve constipation, after it was linked to increased risk of serious cardiovascular events including a higher chance of heart attack, stroke and worsening chest pain.

Novartis has agreed to voluntarily suspend marketing of the drug in the United States, on the FDA's request. After being approved for treatment of chronic constipation for men and women under age 65, Zelnorm is currently still being marketed in 55 countries

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