USA – FDA studies: No post-ingestion NDMA from ranitidine

An editorial that accompanied two recent studies examining the potential for nitrosamine formation from the antacid ranitidine welcomed reassuring news provided by the US Food and Drug Administration- (FDA-) led investigations.

The two FDA-led studies taken together “should serve to alleviate much of the previous concern about [N-nitrosodimethylamine] production of dimethylamine drugs in the human body,” according to C. Michael White of the School of Pharmacy at the University of Connecticut and Adrian Hernandez of Hartford (CT) Hospital and Lima, Peru’s Universidad San Ignacio de Loyola, writing in the 28 June online edition of JAMA.

In April 2020, FDA requested that all ranitidine be pulled from the market because of the risk of contamination with the potential carcinogen N-nitrosodimethylamine (NDMA)…