Some ranitidine medicines, including Zantac, contain low levels of an impurity called N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen, the FDA announced on Sept. 13.
The drug, an over-the-counter (OTC) and prescription histamine H2-receptor antagonist, is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease. The FDA has been investigating NDMA and other nitrosamine impurities in angiotensin II receptor blockers since last year, which has resulted in numerous recalls.
At this time, the FDA is not calling for individuals to stop taking ranitidine. However, those taking prescription ranitidine who wish to discontinue use should talk to their clinician about other treatment options, and those taking OTC ranitidine could consider other OTC medications approved for their condition, the agency said.