Professor Thomson

The North American and European Societies of Paediatric Gastroenterology are aware of the recent FDA statement about Ranitidine and in particular the over the counter preparation made by one manufacturer. The societies have been in conversation with the FDA which is the drug regulation authority in the United States and the following is their statement:-

“The US Food and Drug Administration has learned that some Ranitidine medicines, including some products commonly know 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 know environmental contaminant and 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 medicines called Angiotensin II Receptor blockers (ARBs) since last year and when it discovered an acceptable levels of Nitrosamines, the ARBs have been recalled.

The FDA is evaluating whether the low levels of NDMA in Ranitidine (Zantac) pose a risk to patients and will post this 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 healthcare professional about other treatment options. People taking over the counter Ranitidine should consider using other over the counter medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as Ranitidine.

Consumer and healthcare professionals should report any adverse reactions to Ranitidine to the FDA. Medwatch Programme to help the agency better understand the scope of the problem. “

Professor Thomson and colleagues will keep patients fully informed as developments occur but at the present moment the advice is not to stop Ranitidine.