FDA declares Pepcid, Nexium and others free of NDMA contamination

The bad news for heartburn sufferers, of course, is that Zantac and its ranitidine generics have, perhaps for years, contained a suspected carcinogen without the FDA knowing it. The good news is that the FDA has now declared a handful of branded antacid alternatives and their generics as safe for consumers.

The FDA Wednesday said that preliminary tests of alternatives including Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole) found no N-nitrosodimethylamine (NDMA), the suspected cancer-causing agent found in OTC ranitidine drugs including the popular Zantac.

The announcement came as the agency said more Zantac generic makers are voluntarily calling their meds. Dr. Reddy’s Laboratories confirmed that NDMA had been found in its ranitidine products, and Perrigo has joined the recall after testing its versions.

The recent discovery of NDMA in Zantac and its generics came after the finding last year that the impurity was being created during the manufacturing of many high blood pressure drugs like losartan and valsartan.

The online pharmacy Valisure, which tests all of the products it sells, notified the FDA earlier this year that it had found a similar manufacturing phenomenon was occurring in ranitidine drugs. Valisure filed a citizen petition seeking to have the FDA have drugmakers recall the suspected products, set an acceptable NDMA level and create tests for the suspected carcinogen.

While the FDA has rejected Valisure’s testing methods, the agency has set standards and informed drugmakers how to test for NDMA in ranitidine. It announced Wednesday a new test using what it called “a more widely available technology than the first posted method.”

https://www.fiercepharma.com/manufacturing/need-a-safe-antacid-for-heartburn-fda-declares-pepcid-nexium-and-others-free-ndma