Statement alerting patients and health care professionals of NDMA found in samples of ranitidine
FDA警示在雷尼替丁樣品中檢出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發(fā)現(xiàn)有些雷尼替尼藥品（包括通常稱為善胃得的一些藥品）中含有低水平亞硝胺雜質(zhì)NDMA。根據(jù)實驗室檢測結(jié)果，NDMA為人體可能致癌物質(zhì)。NDMA為已知環(huán)境污染物，在水中和食品包括肉類、奶制品和植物中均有發(fā)現(xiàn)過。
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對高血壓和心力衰竭藥品（稱為ARB）中的NDMA和其它亞硝胺類雜質(zhì)進行調(diào)查，F(xiàn)DA在發(fā)現(xiàn)亞硝胺類處于不可接受水平時已建議召回許多產(chǎn)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發(fā)現(xiàn)問題時，會快速采取適當(dāng)措施保護患者。FDA正在評估在雷尼替丁中低水平的NDMA是否會對患者有風(fēng)險。FDA在獲得這些信息時會在網(wǎng)上發(fā)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.
患者應(yīng)信任其藥品已盡可能安全，服用這些藥品的益處大于對其健康的風(fēng)險。盡管NDMA在高水平時可能導(dǎo)致傷害，F(xiàn)DA經(jīng)初步檢測在雷尼替丁中發(fā)現(xiàn)的水平僅比普通食品中可能出現(xiàn)的數(shù)量多一點。
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.
雷尼替丁為OTC和處方藥品。雷尼替丁為H2阻斷劑，其減少胃酸分泌。OTC雷尼替丁經(jīng)批準(zhǔn)用于預(yù)防和緩解因消化和胃酸引起的胃灼熱。處方雷尼替丁批準(zhǔn)用于多種癥狀，包括胃腸潰瘍和胃食管反流病治療。
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正與國際藥監(jiān)機構(gòu)與企業(yè)伙伴確定雷尼替丁中該雜質(zhì)的來源。FDA正在檢測雷尼替丁中的NDMA水平，評估對患者的所有可能風(fēng)險。FDA將根據(jù)持續(xù)調(diào)查的結(jié)果采取適當(dāng)措施。FDA將在獲得更多信息時向公眾發(fā)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并未號召所有人在目前停止服用雷尼替尼，但正在服用處方雷尼替丁且不希望繼續(xù)服用的患者應(yīng)與其醫(yī)生討論治療方案。正在服用OTC雷尼替丁的人們可考慮使用其它已批準(zhǔn)的治療其癥狀的OTC藥品。市場上有多個藥品被批準(zhǔn)用于與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:
患者與衛(wèi)生人員應(yīng)向FDA報告雷尼替丁不良反應(yīng)以幫助FDA更好了解問題發(fā)生范圍。
Complete and submit the report online at www.fda.gov/medwatch/report.htm
在線填寫并提交報告
Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178
下載并填寫適當(dāng)表格后通過傳真提交
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.
