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The US Food and Drug Administration has learned that certain ranitidine-based medicines, including certain products known as Zantac branded contain an impurity of nitrosamine called N-nitrosodimethylamine (NDMA) at low concentration. NDMA is classified as possibly carcinogenic to humans (a substance that can cause cancer) according to the results of laboratory tests. NDMA is a known environmental contaminant and is found in water and food, including meats, dairy products and vegetables.
The FDA has investigated NDMA inhibitors and other nitrosamine impurities in low blood pressure and heart failure medications, called angiotensin II receptor antagonists (ARBs), since last year. In the case of ARBs, the FDA has recommended many recalls as it has discovered unacceptable levels of nitrosamines.
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When the agency identifies a problem, it quickly takes the appropriate steps to protect the patients. The FDA is assessing whether low levels of NDMA in ranitidine pose a risk to patients. The FDA will publish this information when it becomes available.
Patients need to be confident that their medications are as safe as possible and that the benefits of taking them outweigh the health risks. Although NDMA can cause a lot of damage, the FDA concentrations in ranitidine from preliminary tests barely exceed the amounts you can expect to find in common foods.
Ranitidine is an over-the-counter and prescription medication. Ranitidine is an anti-H2 (histamine-2), which decreases the amount of acid created by the stomach. OTC Ranitidine is approved to prevent and relieve stomach burns associated with acid ingestion and stomach. Ranitidine Prescription is approved for multiple indications, including treatment and prevention of stomach and intestinal ulcers 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 reviewing NDMA levels in ranitidine and assessing potential risks to patients. The FDA will take appropriate action based on the results of the ongoing investigation. The agency will provide more information as soon as they are available.
The FDA does not call individuals to stop taking ranitidine for the time being; However, patients taking prescription ranitidine who wish to discontinue their use should consult their health care professional about other treatment options. People taking over-the-counter ranitidine may consider using other over-the-counter medications approved for their disease. There are several drugs on the market that are approved for the same or similar uses to ranitidine.
Consumers and health care professionals should report any adverse reactions caused by ranitidine to the FDA's MedWatch program to help it better understand the extent of the problem:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm.
- Download and complete the appropriate form and send it by fax 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 veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety of food products, cosmetics, food supplements, products emitting electronic radiation and the regulation of tobacco products.
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