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台灣:食藥署說明胃藥成分中ranitidine原料藥含NDMA不純物事件之調查現況 (Chinese only)
 
台灣衛生福利部食品藥物管理署(以下簡稱食藥署)於監視國際藥物安全訊息時,發現有關胃藥成分中ranitidine原料藥含有不純物「N-亞硝基二甲胺 (N-nitrosodimethylamine, NDMA)」成分,食藥署已立即啟動全面清查作業,針對台灣ranitidine藥品中健保用量較大的製劑及原料藥優先抽樣,以儘速釐清可能受影響之情況,且已於2019年9月18日要求業者針對市售效期內所有ranitidine成分原料藥及製劑進行檢驗,並於2019年10月18日前回報檢驗結果。
  
目前ranitidine產生NDMA之原因各國仍於調查階段中,台灣核可該成分之藥品許可證共38張,為保障民眾健康,食藥署已發函要求持有該類成分藥品許可證持有商(21家持有商)應立即主動調查及檢驗NDMA不純物,針對所有ranitidine成分原料藥進行檢驗,未檢出NDMA始得供製造使用,若製劑檢驗不符合規定者,應立即停止販售。

另該等藥品主要用於胃灼熱、消化不良(酸引起)、胃酸過多、十二指腸潰瘍等,若民眾對使用之藥品有任何疑慮,可洽鄰近藥局或回診諮詢醫師。後續,食藥署將持續與國際合作,以快速取得最新資訊,對於受影響藥品,將即時公布受影響藥品資訊,並透過多重管道提醒醫療人員及民眾注意,以保障民眾用藥安全。

詳情請按以下連結: http://www.fda.gov.tw/../newsContent.aspx?cid=4&id=t549065

在香港,有67種註冊藥劑製品含有雷尼替丁。這些產品包括口服製劑和注射劑型,分別屬於非處方藥物和醫生處方藥物。至今,衞生署未接獲任何涉及雷尼替丁的藥物不良反應個案。

歐洲藥物監管局、美國食物及藥物管理局、加拿大衞生局、新加坡衞生科學局和澳洲藥物管理局早前已公布有關在雷尼替丁產品中檢測到N-亞硝基二甲胺(NDMA)的消息,而相關資訊已在2019年9月16日、2019年9月17日和2019年9月18日刊登於藥物辦公室的網頁。衞生署已在2019年9月18日發信通知本地醫護專業人員。衞生署已聯絡有關海外藥物監管局以獲取在雷尼替丁產品中檢測到NDMA的進一步資料,並繼續對有關監管局公布的最新調查結果保持警惕。

衞生署一直聯絡所有註冊雷尼替丁產品的註冊證書持有人以跟進這事件的本地影響。衞生署會繼續對事件的發展和海外藥物監管局就此藥物發出的安全更新保持警惕,以考慮任何必要的行動。

正在服用含有雷尼替丁產品的病人不應自行停止服用藥物,他們應盡快向其醫護人員諮詢意見,以作適當安排,例如使用有類似用途的替代藥物。


2019年9月19日 (星期四)
香港時間17時正
 
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