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台湾:食药署说明胃药成分中ranitidine原料药含NDMA不纯物事件之调查现况
 
台湾卫生福利部食品药物管理署(以下简称食药署)于监视国际药物安全讯息时,发现有关胃药成分中ranitidine原料药含有不纯物「N-亚硝基二甲胺 (N-nitrosodimethylamine, NDMA)」成分,食药署已立即启动全面清查作业,针对台湾ranitidine药品中健保用量较大的制剂及原料药优先抽样,以尽速厘清可能受影响之情况,且已于2019年9月18日要求业者针对市售效期内所有ranitidine成分原料药及制剂进行检验,并于2019年10月18日前回报检验结果。
  
目前ranitidine产生NDMA之原因各国仍于调查阶段中,台湾核可该成分之药品许可证共38张,为保障民众健康,食药署已发函要求持有该类成分药品许可证持有商(21家持有商)应立即主动调查及检验NDMA不纯物,针对所有ranitidine成分原料药进行检验,未检出NDMA始得供制造使用,若制剂检验不符合规定者,应立即停止贩售。

另该等药品主要用于胃灼热、消化不良(酸引起)、胃酸过多、十二指肠溃疡等,若民众对使用之药品有任何疑虑,可洽邻近药局或回诊谘询医师。后续,食药署将持续与国际合作,以快速取得最新资讯,对于受影响药品,将即时公布受影响药品资讯,并透过多重管道提醒医疗人员及民众注意,以保障民众用药安全。

详情请按以下连结: http://www.fda.gov.tw/../newsContent.aspx?cid=4&id=t549065

在香港,有67种注册药剂制品含有雷尼替丁。这些产品包括口服制剂和注射剂型,分别属于非处方药物和医生处方药物。至今,卫生署未接获任何涉及雷尼替丁的药物不良反应个案。

欧洲药物监管局、美国食物及药物管理局、加拿大卫生局、新加坡卫生科学局和澳洲药物管理局早前已公布有关在雷尼替丁产品中检测到N-亚硝基二甲胺(NDMA)的消息,而相关资讯已在2019年9月16日、2019年9月17日和2019年9月18日刊登于药物办公室的网页。卫生署已在2019年9月18日发信通知本地医护专业人员。卫生署已联络有关海外药物监管局以获取在雷尼替丁产品中检测到NDMA的进一步资料,并继续对有关监管局公布的最新调查结果保持警惕。

卫生署一直联络所有注册雷尼替丁产品的注册证书持有人以跟进这事件的本地影响。卫生署会继续对事件的发展和海外药物监管局就此药物发出的安全更新保持警惕,以考虑任何必要的行动。

正在服用含有雷尼替丁产品的病人不应自行停止服用药物,他们应尽快向其医护人员谘询意见,以作适当安排,例如使用有类似用途的替代药物。


2019年9月19日 (星期四)
香港时间17时正
 
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