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789
新加坡下架的胃酸药物当中,4个品牌获得马来西亚国家药品注册局注册,卫生部正评估这些药物。
卫生部总监拿督诺希山表示,卫生部正评估所有含有雷尼替丁(Ranitidine)的胃酸药物,以鉴定是否含有N-亚硝基二甲胺(NDMA)成份。
日前,新加坡卫生科学据(HSA)验出含雷尼替丁的胃酸药物中,含有N-亚硝基二甲胺成份;迄今,也只有新加坡要求下架8种含有雷尼替丁的胃酸药物品牌,欧洲药品管理局(EMA)和美国食品药品管理局(USFDA)仍在深入评估有关药物。
无论如何,目前新加坡下架的胃酸药物当中,只有4个品牌获得马来西亚国家药品注册局注册,包括Zantac 品牌的Zantac Tablet 150mg(MAL19871471ARZ)、Zantac Injection 50mg/2ml(MAL19950591ARZ)、Zantac Syrup150mg/10ml(MAL19910829ACRZ),Apo-Ranitidine 150mg Tablet (MAL19986966AZ),Hyzan Tablet 150mg(MAL19984063AZ),Vesyca Film Coated Tablet 150mg(MAL19991131AZ)。
卫生部周五发表指出,雷尼替丁通常用于治疗胃灼热和胃肠疾病,患者可通过医生或注册的药剂行购得,属于正常亚硝胺基团的杂质之一。
根据国际癌症研究机构(IARC)统计,长期服用N-亚硝基二甲胺,可增加患癌风险。
尽管短暂使用雷尼替丁( 可能含有N-亚硝基二甲胺)患癌风险非常低,但大马卫生仍正视这个问题的风险 。
因此,服用有关药物这在必要时可寻求专业人员的建议,或以另一种药物作为替代。
国家药品监督管理局将继续与产品注册公司配合,确保药物的质量、安全和有效性,一旦完成评估,将对有关药物采取行动,并作出公布。
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