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Following the example of the West, health regulators in China have issued an order withdrawing Novartis’ irritable bowel syndrome drug Zelmac® (tegaserod) from the market.
The country’s 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”. China’s move comes in the wake of similar decisions taken in the USA and more recently Switzerland, where sales of the drug have been suspended amid fears of cardiovascular risk.
Those particular decisions followed Novartis’ notification about a retrospective analysis of data from more than 18,000 patients on its clinical trial database. The data showed that events occurred in 13 out of 11,614 patients treated with Zelnorm, compared to one case in 7,031 placebo-treated patients.
Zelnorm has been available in China since 2003 and the country’s National Centre for Adverse Drug Reaction Monitoring has received 98 reports of adverse reactions, notably diarrhoea and nausea. One case of tachycardia was reported, as were two concerning heart palpitations and one case of low blood pressure.
The SFDA has ordered two drug companies in the southern city of Chongqing and one Beijing manufacturer to stop production of the drug, which the official Xinhua News Agency says is used by several hundred thousand Chinese patients. However, the withdrawal is not expected to have any significant impact on Novartis sales.
PharmaTimes 11/6/2007
