Lab tests confirm low levels of NDMA in the popular heart burn medication, sparking a probe in the US and Europe.
The US Food and Drug Administration has announced a new probe into ranitidine (Zantac) due to low levels of a carcinogen.
The FDA called on the probe into the popular drug to treat heart burn after laboratory tests confirm low levels of a nitrosamine impurity called N-nitrosodimethylamine (NDMA), a known environmental contaminant found in water and foods such as meats, dairy products, and vegetables.
The FDA has been investigating NDMA, as well as other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers since 2018, resulting in numerous recalls.
The probe calls for the FDA to evaluate whether the low levels of NDMA in ranitidine pose a risk to patients. In preliminary tests, the levels of NDMA found barely exceed the amounts expected in common foods.
Ranitidine, an H2 blocker, is available both as a prescription for multiple indications including the treatment of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease and over-the-counter for heartburn. The drug decreases the amount of acid created by the stomach.
The FDA is not calling for individuals to stop taking ranitidine at this time, but suggest patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options.
The European Medicines Agency also released a statement calling for a probe into the medication at the request of the European Commission.
Officials from Sanofi, which produces Zantac, released a statement on the announcement.
"Sanofi takes patient safety seriously, and we are committed to working with the FDA," a spokesperson said in a statement. "Zantac OTC (over the counter) has been around for over a decade and meets all the specified safety requirements for use in the OTC market."