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Effect of oral ranitidine on urinary excretion of N-nitrosodimethylamine (NDMA): A randomized clinical trial

JAMA Jul 24, 2021

Florian J, Matta MK, DePalma R, et al. - In this crossover, randomized clinical trial involving 18 healthy participants (median age, 33.0 [interquartile range {IQR}, 28.3 to 42.8] years; 9 women [50%]; 7 White [39%], 11 African American [61%]; and 3 Hispanic or Latino ethnicity [17%]), researchers sought to assess the 24-hour urinary excretion of N-nitrosodimethylamine (NDMA) after oral administration of ranitidine compared with placebo. Participants were randomly assigned to 1 of 4 treatment sequences and received ranitidine (300 mg) and placebo (randomized order) with a noncured-meats diet and then a cured-meats diet over four periods. Nitrites, nitrates (nitrate-reducing bacteria can convert nitrates to nitrites), and NDMA levels were increased in the cured-meats diet. When participants consumed noncured-meats or cured-meats diets, oral ranitidine (300 mg) did not significantly increase the 24-hour urinary excretion of NDMA when compared with placebo. The data refute the notion that ranitidine can be transformed to NDMA in a healthy population. There were no serious adverse drug events reported.

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