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台湾:食药署公布至2019年9月24日已完成检验得恢复供应、销售之含ranitidine成分药品清单
 
有关胃药成分中ranitidine原料药含有不纯物「N-亚硝基二甲胺 (NDMA)」,卫生福利部食品药物管理署(以下简称食药署)已主动针对台湾ranitidine药品中健保用量较大的制剂及原料药优先抽样,并要求业者启动调查及针对市售效期内所有ranitidine成分原料药及制剂进行检验。为保障民众用药安全,食药署已要求业者应于2019年9月23日前完成含ranitidine成分药品之预防性下架作业,经检验确认合格者,始得恢复供应、销售。目前食药署已确认市售效期内含ranitidine成分药品2项,共12批,经检验合格,即日起得恢复供应、销售。

食药署将持续于本署网站公布得恢复供应、销售含ranitidine成分药品之清单,并持续与国际合作,以快速取得最新资讯,对于受影响的药品,将即时公布资讯,以保障民众用药权益。

详情请按以下连结: http://www.fda.gov.tw/../newsContent.aspx?cid=4&id=t549083

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、澳洲药物管理局和台湾卫生福利部食品药物管理署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,而相关资讯已从2019年9月16日起刊登于药物办公室的网页,最新的更新亦已于2019年9月25日刊登。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。

有关台湾卫生福利部食品药物管理署公布暂停销售雷尼替丁产品,有6个品牌的产品在香港注册,当中2个品牌已暂停销售,另外2个品牌的产品现时并无在港销售。至于新加坡卫生科学局公布回收8个雷尼替丁品牌,有5个品牌在香港注册,当中1个品牌已暂停销售,另外2个品牌的产品现时并无在港销售。

于二零一九年九月二十四日,卫生署同意持牌药物批发商葛兰素史克有限公司采取预防措施,从市面回收所有善胃得(雷尼替丁)产品,因产品含有杂质NDMA。于二零一九年九月二十五日,卫生署同意另外2个持牌药物批发商显荣行有限公司和五丰药业有限公司采取预防措施,分别从市面回收所有爱胃妥药片和Zantidon 150毫克药片产品,因产品可能含有杂质NDMA。善胃得和爱胃妥亦与台湾卫生福利部食品药物管理署和新加坡卫生科学局的公告有关。

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,并要求所有注册证书持有人提供产品内NDMA的含量低于可接受的水平的证据。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26日 (星期四)
香港时间16时正
 
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