EU and US regulators to review ranitidine medicines

Ranitidine, the active ingredient of prescription and over-the-counter drug Zantac, originated by legacy company Glaxo but now available as a generic, has come under scrutiny by both the European Medicines Agency and the US Food and Drug Administration as a result of findings of contamination with a carcinogen.

Ranitidine medicines are used widely to reduce the production of stomach acid in patients with conditions such as heartburn and stomach ulcers.

On Friday, the FDA said it had 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. 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.