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Potential carcinogen in some versions of popular heartburn medicine Zantac »Heartbeat for the lake community



U.S. The Food and Drug Administration has learned that some ranitidine drugs, including some products commonly known as the Zantac brand, contain a low-level nitrosamine impurity called N-nitrosodimethylamine (NDMA). NDMA is classified as a probable carcinogen (a substance that can cause cancer) based on laboratory test results. NDMA is a well-known environmental pollutant and is found in water and foods, including meat, dairy products and vegetables.

The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medications called Angiotensin II Receptor Blockers (ARBs) since last year. For ARBs, the FDA has recommended a series of recalls when it detected unacceptable levels of nitrosamines.

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When the agency identifies a problem, it quickly takes the necessary steps to protect patients. The FDA evaluates whether the low levels of NDMA in ranitidine pose a risk to patients. The FDA will post this information when available.

Patients should be able to trust that their medications are as safe as they can be and that the benefits of taking them outweigh any risks to their health. Although NDMA can cause large amounts of damage, levels of FDA in ranitidine from preliminary tests hardly exceed those you might expect to find in regular foods.

Ranitidine is a non-prescription drug (OTC). Ranitidine is an H2 (histamine-2) blocker, which reduces the amount of acid that the stomach creates. Rapid cancer ranitidine is approved to prevent and relieve heartburn associated with acid intake and acidic stomach. Prescription ranitidine is approved for several indications, including treatment and prevention of ulcers 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 examines the levels of NDMA in ranitidine and evaluates the potential risk to patients. The FDA will take appropriate action based on the results of the ongoing investigation. The Agency will provide more information as it becomes available.

The FDA does not ask individuals to stop taking ranitidine at this time; However, patients taking prescription ranitidine who wish to discontinue use should talk to other health care providers about other treatment options. People taking OTC ranitidine may consider using other OTC medicines approved for their condition. There are several drugs on the market that are approved for the same or similar use as ranitidine.

Consumers and health professionals should report any ranitidine adverse reactions to the FDA's MedWatch program to help the agency understand the scope of the problem:

  • Complete and submit the report online at www.fda.gov/medwatch/report.htmebrit19659011achteDownload and fill in the appropriate form, then fax it to 1-800-FDA-0178

The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of human and human health. veterinary medicines, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety and security of the country's food supply, cosmetics, supplements, products that emit electronic radiation and for the regulation of tobacco products.

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