Effect of Oral Ranitidine on Urinary Excretion of N-Nitrosodimethylamine (NDMA): A Randomized Clinical Trial.

ABSTRACT:

Importance

In 2019, the US Food and Drug Administration (FDA) received a citizen petition indicating that ranitidine contained the probable human carcinogen N-nitrosodimethylamine (NDMA). In addition, the petitioner proposed that ranitidine could convert to NDMA in humans; however, this was primarily based on a small clinical study that detected an increase in urinary excretion of NDMA after oral ranitidine consumption.

Objective

To evaluate the 24-hour urinary excretion of NDMA after oral administration of ranitidine compared with placebo.

Design, setting, and participants

Randomized, double-blind, placebo-controlled, crossover clinical trial at a clinical pharmacology unit (West Bend, Wisconsin) conducted in 18 healthy participants. The study began in June 2020, and

SUBMITTER: Florian J 

PROVIDER: S-EPMC8240005 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature