FDA issues warning for brand-name drug Zantac
Statement alerting patients and health care professionals of NDMA found in samples of ranitidine.
Official response from NASPGHAN:
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, and when it discovered unacceptable levels of nitrosamines the ARBs have been recalled.
The FDA is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients and will post that information when it is available.
It is important to note that 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.
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 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 on the 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 program to 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
Click link below to FDA press announcement