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Drug Watchdog Suspends Production, Marketing of IBS Drug
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China's drug watchdog on Friday ordered the suspension of production, sale and use of Zelnorm, a drug taken for irritable bowel syndrome (IBS) after the medicine was linked to an increase risk of heart attacks and strokes.

The State Food and Drug Administration said it had made the decision because "the risks of Zelnorm outweigh the possible benefits for some patients based on analyses from home and abroad."

Zelnorm was approved in 2002 for treatment of irritable bowel syndrome and constipation.

However, the National Center for Adverse Drug Reaction Monitoring has received 98 reports of adverse reactions concerning Zelnorm since 2003 when the medicine was introduced to the Chinese market.

Major reactions were diarrhoea and nausea, according to the center, adding that there was one case of tachycardia - abnormally rapid beating of the heart - two concerning heart palpitations and one case of low blood pressure.

A review of data from 18,000 patients taking the medicine conducted by Novartis AG, Switzerland's largest drug maker, showed that a significant number had experienced cardiovascular problems.

Several countries including the United States and Canada have recently called a halt to the marketing of Zelnorm which have been approved in 55 countries in the world.

China now has three drug companies producing Zelnorm. The drug is available in more than 20 provinces, regions and municipalities at present with hundreds of thousands of users.

(Xinhua News Agency June 9, 2007)

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