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June 28, 2021

Ranitidine and Risk of N-Nitrosodimethylamine (NDMA) Formation

Author Affiliations
  • 1Health Outcomes, Policy, and Evidence Synthesis (HOPES) Group, School of Pharmacy, University of Connecticut, Storrs
  • 2Research Administration, Hartford Hospital, Hartford, Connecticut
  • 3Unidad de Revisiones Sistemáticas y Meta-análisis (URSIGET), Vicerrectorado de Investigación, Universidad San Ignacio de Loyola (USIL), Lima, Peru
JAMA. 2021;326(3):225-227. doi:10.1001/jama.2021.10043

The US Food and Drug Administration (FDA) limits the amount of the probable carcinogen N-nitrosodimethylamine (NDMA) in a daily dose of medication to 96 ng.1 Chronic NDMA exposure has been shown to induce liver and lung cancer in animals, while high-dose acute NDMA poisoning can damage the liver and induce gastrointestinal and hepatic bleeding.2 Since 2019, NDMA exceeding this amount was found in numerous lots of several medications—such as angiotensin receptor blockers, sustained-release metformin, and ranitidine—and led to widespread recalls of several products and concern among patients and clinicians.3 On April 1, 2020, based on an ongoing investigation of NDMA in ranitidine, the FDA requested manufacturers of ranitidine to remove all over-the-counter and prescription ranitidine products from the market.4