Statement alerting patients and health care professionals of NDMA found in samples of ranitidine
FDA警示在雷尼替丁样品中检出NDMA
For Immediate Release:
September 13, 2019
Statement From:
Director - Center for Drug Evaluation and Research
Janet Woodcock M.D.
The U.S. Food and Drug Administration 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.
FDA发现有些雷尼替尼药品（包括通常称为善胃得的一些药品）中含有低水平亚硝胺杂质NDMA。根据实验室检测结果，NDMA为人体可能致癌物质。NDMA为已知环境污染物，在水中和食品包括肉类、奶制品和植物中均有发现过。
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.
FDA自去年至今年一直在对高血压和心力衰竭药品（称为ARB）中的NDMA和其它亚硝胺类杂质进行调查，FDA在发现亚硝胺类处于不可接受水平时已建议召回许多产品。
When the agency identifies a problem, it takes appropriate action quickly to protect patients. The FDA is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients. FDA will post that information when it is available.
如果FDA发现问题时，会快速采取适当措施保护患者。FDA正在评估在雷尼替丁中低水平的NDMA是否会对患者有风险。FDA在获得这些信息时会在网上发布。
Patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking themout weigh any risk to their health. Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.
患者应信任其药品已尽可能安全，服用这些药品的益处大于对其健康的风险。尽管NDMA在高水平时可能导致伤害，FDA经初步检测在雷尼替丁中发现的水平仅比普通食品中可能出现的数量多一点。
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.
雷尼替丁为OTC和处方药品。雷尼替丁为H2阻断剂，其减少胃酸分泌。OTC雷尼替丁经批准用于预防和缓解因消化和胃酸引起的胃灼热。处方雷尼替丁批准用于多种症状，包括胃肠溃疡和胃食管反流病治疗。
The agency is working with international regulators and industry partners to determine the source of this impurity in ranitidine. The agency is examining levels of NDMA in ranitidine and evaluating any possible risk to patients. The FDA will take appropriate measures based on the results of the ongoing investigation. The agency will provide more information as it becomes available.
FDA正与国际药监机构与企业伙伴确定雷尼替丁中该杂质的来源。FDA正在检测雷尼替丁中的NDMA水平，评估对患者的所有可能风险。FDA将根据持续调查的结果采取适当措施。FDA将在获得更多信息时向公众发布。
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 onthe market that are approved for the same or similar uses as ranitidine.
FDA并未号召所有人在目前停止服用雷尼替尼，但正在服用处方雷尼替丁且不希望继续服用的患者应与其医生讨论治疗方案。正在服用OTC雷尼替丁的人们可考虑使用其它已批准的治疗其症状的OTC药品。市场上有多个药品被批准用于与雷尼替丁相同的用途。
Consumers and health care professionals should report any adverse reactions with ranitidine to the FDA’sMedWatch program to help the agency better understand the scope of the problem:
患者与卫生人员应向FDA报告雷尼替丁不良反应以帮助FDA更好了解问题发生范围。
Complete and submit the report online at www.fda.gov/medwatch/report.htm
在线填写并提交报告
Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178
下载并填写适当表格后通过传真提交
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
