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TOPIC: Zantac (ranitidine): Safety Information - NDMA Found in Samples of Some Ranitidine Medicines
AUDIENCE: Consumer, Patient, Health Professional, Pharmacy
ISSUE: FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
BACKGROUND: Ranitidine is an over-the-counter (OTC) and prescription drug. Ranitidine is an H2 (histamine-2) blocker, which decreases the amount of acid created by the stomach. Over-the-counter Ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour 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. The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.
RECOMMENDATION: The FDA is not calling for individuals to stop taking ranitidine at this time; however, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/safety/medical-product-safety-information/zantac-ranitidine-safety-information-ndma-found-samples-some-ranitidine-medicines
美國FDA發現某些含ranitidine成分之藥品，包括廣為人知的Zantac，都含有少量稱為N-亞硝基二甲胺(NDMA)的亞硝胺不純物。NDMA為一種已知的環境污染物，存在於水和食物(包括肉，奶製品和蔬菜)中。根據實驗結果，NDMA被歸類為可能的人類致癌物。
Ranitidine是一種H2 (histamine-2) 阻斷劑，可減少由胃產生的胃酸量。在美國依其適應症分為非處方藥(over-the-counter, OTC)和處方藥。OTC ranitidine被核准用於預防和緩解因胃酸而引起的心灼熱。處方藥ranitidine被核准用於多種適應症，包括治療和預防胃和腸道潰瘍及治療胃食道逆流。自去年以來，美國FDA一直在進行血壓和心衰竭藥品angiotensin II receptor blockers (ARBs)中的NDMA和其他亞硝胺不純物之相關研究。就ARB而言，由於檢出亞硝胺之量超過可接受範圍，美國FDA已建議進行多次藥品回收。
美國FDA目前未要求病人停止服用ranitidine。但服用處方藥ranitidine的病人若希望停止用藥，應先與醫療專業人員討論其他適合的治療選擇。服用OTC ranitidine的人則可以考慮使用市面上其他經核准可用於與ranitidine相同或相似的適應症的OTC藥品。
更多相關訊息與連結請參考FDA網址：
https://www.fda.gov/safety/medical-product-safety-information/zantac-ranitidine-safety-information-ndma-found-samples-some-ranitidine-medicines
[Posted 09/13/2019]
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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