US FDA and EU Investigating Carcinogen Detected in Versions of Zantac Heartburn Drug

Bloomburg News reports that Food & Drug Administration officials in the United States and other health departments in the EU are looking into the widely-used heartburn medication Zantac and its generic versions after a carcinogen was found in the drugs, the same contaminant that sparked a worldwide recall of blood-pressure pills, including Losartan, starting last year.

Medication regulators announced Friday that they were looking at whether Ranitidine prescription drugs contained significant levels of the probable carcinogen NDMA that could represent a risk to patients. The investigation comes after an online pharmacy that tests every drug it dispenses alerted the U.S. F.D.A. to their discovery of high levels of the substance in generic and name-brand versions of Zantac sold through major pharmacies operated by corporations including Walgreens, CVS, and Walmart.

The US Federal Drug Administration’s statement:

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. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.

Janet Woodcock M.D. , Director – Center for Drug Evaluation and Research

More on this story as information becomes available.