FDA warns against impurities in Zantac and its generic versions

The US Food and Drug Administration has warned that the drug Zantac and its generic variants could contain a potentially carcinogenic nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels.

NDMA was classified as a probable human carcinogen based on results from laboratory tests and was known to be able to contaminate water and some foods.

The FDA opened an investigation into NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) last year and found unacceptable levels of nitrosamines.

According to Bloomberg, the review was triggered after an online pharmacy that tests every drug it dispenses alerted the U.S. Food and Drug Administration that it had found high levels of the compound in generic and name-brand versions of Zantac sold at major pharmacies operated by companies including Walgreens Boots Alliance Inc., CVS Health Corp. and Walmart Inc..

The FDA was reportedly still evaluating whether the low levels of NDMA in ranitidine - the name of the generic form of the drug - posed a risk to patients and working with international regulators and industry partners to determine the source of this impurity in ranitidine.