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替加色罗由于致命性心脏不良反应而撤市诺华制药集团与 FDA 商议后已同意将替加色罗(tegas-erod)撤市。该药主要用于女性便秘型肠易激综合征的缓解症状及65岁以下慢性便秘患者的短期治疗给药。这是从下面一项新的安全性分析中作出的评估:FDA 分析了29个该药治疗各种胃肠系疾患的临床研究报告。此项临床试验包括11614例替加色罗治疗和7031例糖丸安慰剂治疗。患者平均年龄为34岁,88%患者为妇女。替加色罗组有13例(0.1%)发生严重致命性心血管不良反应,其中4例心脏病发作(1例死亡);6例发生严重心绞痛并很快转为心脏病发
Tegaserod was withdrawn due to fatal adverse cardiac reactions Novartis Pharmaceutical Group had agreed to withdraw tegas-erod after consultation with the FDA. The drug is mainly used for the relief of symptoms of female constipation-predominant irritable bowel syndrome and short-term treatment of chronic constipation patients under 65 years of age. This is an assessment made from the following new safety analysis: The FDA analyzed 29 clinical studies of this drug for the treatment of various gastrointestinal disorders. This clinical trial included 11614 patients treated with tegaserod and 7031 patients treated with placebo. The average age of the patients was 34 years and 88% of the patients were women. Severe fatal cardiovascular adverse reactions occurred in 13 patients (0.1%) in the tegaserod group, of which 4 had a heart attack (1 death); 6 had severe angina and soon turned to heart attack