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Ranitidine and Risk of N-Nitrosodimethylamine (NDMA) Formation

Ranitidine and Risk of N-Nitrosodimethylamine (NDMA) Formation Opinion EDITORIAL C. Michael White, PharmD; Adrian V. Hernandez, MD, PhD The US Food and Drug Administration (FDA) limits the amount mingled with ranitidine in an acidic medium. According to of the probable carcinogen N-nitrosodimethylamine (NDMA) the World Health Organization, long-term total daily in- in a daily dose of medication to 96 ng. Chronic NDMA expo- gested NDMA amounts from all sources in an average male adult should remain below 200 ng, because the 70-year esti- sure has been shown to induce liver and lung cancer in animals, while high-dose mated risk of cancer for this ingested amount would be less acute NDMA poisoning can than 1 in 100 000. However, it is estimated that the average Related article page 240 damage the liver and induce adult consumes 100 to 110 ng of NDMA daily in the water gastrointestinal and hepatic and food supply. This means that exceeding 100 ng of Related article at bleeding. Since 2019, NDMA NDMA daily from prescription drugs (either in the product at jamanetworkopen.com exceeding this amount was ingestion or converted in the stomach) would increase the found in numerous lots of several medications—such as an- risk of cancer beyond negligible and supports the http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Ranitidine and Risk of N-Nitrosodimethylamine (NDMA) Formation

JAMA , Volume 326 (3) – Jul 20, 2021

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Publisher
American Medical Association
Copyright
Copyright 2021 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2021.10043
Publisher site
See Article on Publisher Site

Abstract

Opinion EDITORIAL C. Michael White, PharmD; Adrian V. Hernandez, MD, PhD The US Food and Drug Administration (FDA) limits the amount mingled with ranitidine in an acidic medium. According to of the probable carcinogen N-nitrosodimethylamine (NDMA) the World Health Organization, long-term total daily in- in a daily dose of medication to 96 ng. Chronic NDMA expo- gested NDMA amounts from all sources in an average male adult should remain below 200 ng, because the 70-year esti- sure has been shown to induce liver and lung cancer in animals, while high-dose mated risk of cancer for this ingested amount would be less acute NDMA poisoning can than 1 in 100 000. However, it is estimated that the average Related article page 240 damage the liver and induce adult consumes 100 to 110 ng of NDMA daily in the water gastrointestinal and hepatic and food supply. This means that exceeding 100 ng of Related article at bleeding. Since 2019, NDMA NDMA daily from prescription drugs (either in the product at jamanetworkopen.com exceeding this amount was ingestion or converted in the stomach) would increase the found in numerous lots of several medications—such as an- risk of cancer beyond negligible and supports the

Journal

JAMAAmerican Medical Association

Published: Jul 20, 2021

References