SFDA announced on June 8, 2007, the relative organizations must stop producing, marketing and using Zelnorm(tegaserod maleate) in China, and manufacturers recall all the saled products, because an increased risk of serious cardiovascular adverse events associated with use of the drug. Zelnorm is a prescription medicine for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation.

National Center for ADR Monitoring (China) totally received 98 adverse reactions of tegaserod maleate, cardiovascular adverse events including: tachycardia(1 case), hypotension(1 case), flustered(2 cases). There is no ADR of ischemic cardiovascular disease found in China associated with use of the drug.

Recently Novartis had withdrawed Zelnorm from the markets in USA, Canada etc. SFDA organized experts to estimate the rish of Zelnorm, and found the risk of the drug is big than its benefit, so SFDA issued the announcement. Except Beijing Novartis Co., Ltd, Chongqing Huapang Pharmaceutcial Co., Ltd and Chongqing Yaoyou Pharmaceutcial Co., Ltd also produce tegaserod maleate. They shoud stop producing the products and recall their products.