FDA MedWatch - All Ranitidine Products (Zantac): Press Release - FDA Requests Removal (1)
AUDIENCE: Consumer, Patient, Health Professional, Gastroenterology
ISSUE: The FDA announced it is requesting manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.
This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). NDMA is a probable human carcinogen (a substance that could cause cancer). FDA has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.
BACKGROUND: Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
RECOMMENDATION:
• Consumers: The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products.
美國FDA宣布已要求製造商立即下架所有含ranitidine的處方藥和非處方藥(over-the-counter , OTC)，這是對ranitidine(原廠藥名Zantac)產品中汙染物N-Nitrosodimethylamine (NDMA)審查的最新進度。NDMA為一種人類的致癌物，美國FDA已確定某些ranitidine產品中的不純物會隨著時間增加，且儲存在高於室溫的條件下可能導致消費者所接觸的不純物高於接受值。由於被美國FDA要求立即下市，ranitidine產品在美國將無法再作為處方藥或非處方藥使用。
Ranitidine為H2-blocker，可以減少胃酸的分泌量。Ranitidine核准用於多種適應症，包含治療和預防腸胃潰瘍、治療胃食道逆流疾病。
建議：
1. 美國FDA建議正在使用ranitidine之消費者，停止服用目前所擁有的任何OTC ranitidine錠劑或溶液劑，妥善地處理和丟棄，且切勿囤購。欲繼續治療疾病的病人應考慮使用其他核准的OTC產品。
（待續）
更多相關訊息與連結請參考FDA網址：https://reurl.cc/lVz6Kd
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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