本新闻FDA官网链接https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine?utm_campaign=FDA%20releases%20add%20NDMA%20testing%20method%20%26%20alerts%20HCPs%20%26%20patients%20to%20mult%20vol%20recalls%20of%20ranitidine&utm_medium=email&utm_source=Eloqua

FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)

FDA更新发布：雷尼替丁中NDMA

10/23/19:UPDATE - FDA releases additional NDMA testing method and alerts health care professionals and patients to multiple voluntary recalls of ranitidine

20191023：FDA发布另一份NDMA检测方法，以及警示医护人员和患者多起雷尼替丁主动召回

Update [10/23/19] The U.S. Food and Drug Administration is releasing a second liquid chromatography-mass spectrometry (LC- MS) method for manufacturers and regulators to detect and quantify NDMA in ranitidine. The agency is using this method to test potential NDMA-containing ranitidine samples. The second LC-MS method for NDMA in ranitidine uses a more widely available technology than the first posted method. The agency is sharing the second method to provide alternatives to firms wishing to test their drug products for NDMA.

更新【20191023】美国FDA现发布第二个LC-MS方法，供生产商和药监检出和定量雷尼替丁中的NDMA。FDA目前正使用该方法检测可能含有NDMA的雷尼替丁样品。第二个LC-MS方法使用技术比第一个方法更为普及。FDA在此分享第二个方法，为想要检测其药品中NDMA的公司提供替代方法。

FDA is also alerting health care professionals and patients to two voluntary recalls of ranitidine:

FDA亦警示医护专业人员和患者以下两起雷尼替丁主动召回事件：

Dr. Reddy’s Laboratories Ltd is voluntary recalling all prescription and over-the-counter (OTC) ranitidine tablets and capsules manufactured by the company. The OTC medicines may be labeled by retailers such as Walgreens, Walmart, CVS, Target, and Kroger.

Dr. Reddy’s主动召回其生产的所有处方和OTC雷尼替丁片剂和胶囊。OTC药品可能由分销商如Walgreens、Walmart、CVS、Target和Kroger贴标。

Sanofi is voluntarily recalling OTC ranitidine due to possible NDMA contamination.

赛诺菲主动召回OTC雷尼替丁，因其可能被NDMA污染。（译注：赛诺菲（杭州）在中国持有雷尼替丁片剂和胶囊两份批件，召回通告称其在美国加拿大以外的国家地区所用原料药来自不同供应商，目前召回范围为美国与加拿大）

Patients taking prescription ranitidine who wish to stop should talk to their health care professional about other treatment options. Consumers taking OTC ranitidine, which is used to prevent and relieve heartburn associated with acid indigestion and sour stomach, may consider using other OTC products approved for their condition. FDA’s preliminary tests of alternatives such as Pepcid (famotidine), Tagamet (cimetidine), Nexium(esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole) show no NDMA in these tested medicines at this time.

正在使用处方雷尼替丁的患者如果希望停药，应与其医护人员商量其它治疗选择。正使用OTC雷尼替丁预防和缓解伴随胃酸消化和胃酸的胃灼烧症状的消费者，可考虑使用治疗相同症状的其它已批准药品。FDA对替代药品如法莫替丁、西米替丁、埃索美拉唑、兰索拉唑和奥美拉唑的初步检测显示目前这些被检药品中不含有NDMA。

FDA continues to evaluate the safety of ranitidine and will provide more information as it becomes available. See Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac) for more information.

FDA会继续评估雷尼替丁的安全性，并在获得更多信息时及时发布。

Dr. Reddy’s召回FDA官网链接 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-confirms-its-voluntary-nationwide-recall-all-ranitidine-products-us-market

赛诺菲召回FDA官网链接 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sanofi-provides-update-precautionary-voluntary-recall-zantac-otc-us

第二套LC-MS方法下载FDA官网链接 https://www.fda.gov/media/131868/download