Tag Archives: NDMA

FDA Statement alerting patients and health care professionals of NDMA found in samples of ranitidine

翻译:JULIA 来自:Julia法规翻译

还记得缬沙坦事件吗?NDMA(N-二甲基甲硝胺)又暴雷了,FDA、EMA纷纷发布了信息,在雷尼替丁样品中检出NDMA,以下是原文:

FDA官网链接

https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine?utm_campaign=Statement%20alerting%20patients%20and%20health%20care%20professionals%20of%20NDMA%20found%20in%20samples%20of%20ranitidine&utm_medium=email&utm_source=Eloqua

FDA Statement

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’s MedWatch programto 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.

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EMA官方链接

https://www.ema.europa.eu/en/news/ema-review-ranitidine-medicines-following-detection-ndma

EMA to review ranitidine medicines following detection of NDMA

因检出NDMA,EMA将审核雷尼替丁药品

13 September 2019

EMA/503622/2019

At the request of the European Commission, EMA is to start a review of ranitidine medicines after tests showed that some of these products contained an impurity called N-nitrosodimethylamine (NDMA).

根据EC的要求,由于检验显示有些药品中含有NDMA杂质,EMA将开始对雷尼替丁药品进行审核。

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) on the basis of animal studies. It ispresent in some foods and in water supplies but is not expected to cause harm when ingested in very low levels.

根据动物研究数据,NDMA被分类为可能的人体致癌物质。该物质出现在食品和水中,但预期在非常低水平摄入时不会造成伤害。

EMA is evaluating the data to assess whether patients using ranitidine are at any risk from NDMA and will provide information about this as soon as it is available.

EMA正在评估这些数据,以评估正服用雷尼替丁的患者是否处于NDMA风险中,并在获得相关信息时及时发布。

Ranitidine medicines are used widely to reduce the production of stomach acid in patients with conditions such as heartburn and stomach ulcers. They are available over-the-counter and on prescription.

雷尼替丁药品被广泛用于减少胃灼烧和胃溃疡症状患者的胃酸,有OTC和处方形式。

Patients who have any questions about their current treatment can speak to their doctor or pharmacist. There are several other medicines used for the same conditions as ranitidine that could be used as an alternative.

患者如果对其当前治疗有疑问,可询问其医生或药师。目前有几种和雷尼替丁相同作用的药品可替代使用。

In 2018, NDMA and similar compounds known as nitrosamines were found in a number of blood pressure medicines known as ‘sartans’, leading to some recalls and to an EU review, which set strict new manufacturing requirements for these medicines.

2018年,在大量沙坦类高血压药品中发现了NDMA和类似亚硝胺化合物,导致一些召回和EU审核,之后对这些药品的生产设置了新的严格要求。

EMA is currently working on guidance for avoiding nitrosamines in other classes of medicines. EMA will continue to cooperate with national authorities, EDQM and international partners to protect patients and ensure that effective measures are taken to prevent these impurities from being present in medicines.

EMA目前正在制订一份其它类别药品避免出现亚硝胺杂质的指南。EMA将继续与国家药监、EDMQ和国际伙伴合作以保护患者,确保采取有效措施预防这些杂质出现在药品中。

More about the medicine 关于该药品

Ranitidine belongs to a class of medicines known as H2 (histsamine-2) blockers, which work by blocking histamine receptors in the stomach and reducing the production of stomach acid.

雷尼替丁属于H2阻断剂类药品,其在胃中阻断组胺受体,减少胃酸产生。

It is used to treat and prevent conditions caused by excess acid in the stomach such as heartburn and stomach ulcers.Ranitidine-containing medicines are authorised by national authorities and are available as tablets and injectable formulations.

该药品用于治疗和预防由于胃酸过多引发的症状如胃灼烧和胃溃疡。含雷尼替丁的药品由国家药监批准,有片剂和注射剂两种剂型。

More about the procedure 关于程序

The review of ranitidine medicines was initiated on12 September 2019 at the request of the European Commission, under Article 31 of Directive 2001/83/EC.

对雷尼替丁药品的审核在EC今年EC指令2001/83/EC第31款要求下于2019-09-12启动。

The review will be carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt an opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.

审核将由CHMP执行,其负责关于人药的问题。CHMP的观点将提交EC,并由EC签发最终强制令,在全部EU成员国执行。