Statement alerting patients and health care professionals of NDMA found in samples of ranitidine
For Immediate Release:
September 13, 2019
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.
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.
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.
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.
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 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.
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.
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:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm
- Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178
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.
EMA to review ranitidine medicines following detection of NDMA
13 September 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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.