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N-nitrosodimethylamine (NDMA)

Uses: - primarily used in laboratory research to induce tumors in experimental animals [1] Adverse effects: - probable human carcinogen - hepatotoxic & causes liver cancer in rodents - after follow-up of 5 years, exposure to NDMA-contaminated valsartan was not associated with increased risk of cancer [3] Notes: - several drug products containing valsartan found to contain N-nitrosodimethylamine, NDMA July 2018. Voluntary recall for some, but not all valsartan-containing products. [2] - from July-Sept 2018 > 1/2 of valsartan products on the U.S. market have been recalled because of NDMA impurity, thought to be introduced during manufacturing [3] - found in some ranitidine products including Zantac [4] - NDMA not found in other heartburn medications, including famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), or omeprazole (Prilosec) [5] - levels of NDMA in ranitidine products similar to those in grilled or smoked meats [6] - paper alleging that rantidine increases urinary NMMA retracted [7] - rantidine does not increase urinary NMMA in normal healthy adults [8]

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N-nitrosodiethylamine (NDEA)

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amine

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PUBCHEM cid=6124

References

  1. PubChem: 6124
  2. FDA News Release. July 13, 2018 FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm
  3. Young K. Sadoughi S Physician's First Watch, Sept 13, 2018 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org - Pottegard A et al Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer: Danish nationwide cohort study. BMJ 2018;362:k3851 PMID: 30209057 Free full text https://www.bmj.com/content/362/bmj.k3851 - Banzi R, Bertele V Regulatory response to contaminated valsartan. BMJ 2018;362:k3855 PMID: 30209051 https://www.bmj.com/content/362/bmj.k3855 - Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA's ongoing investigation into valsartan impurities and recalls and an update on FDA's current findings. FDA Statement. Aug 30. 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619024.htm
  4. FDA Safety Alert. Sept 13, 2019 Zantac (ranitidine): Safety Information - NDMA Found in Samples of Some Ranitidine Medicines. https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/zantac-ranitidine-safety-information-ndma-found-samples-some-ranitidine-medicines - FDA Statement. Sept 13, 2019 Statement alerting patients and health care professionals of NDMA found in samples of ranitidine. https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine
  5. FDA News Release. Oct 23, 2019 FDA Updates and Press Announcements on NDMA in Zantac (ranitidine). https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine
  6. Woodcock J. Director - Center for Drug Evaluation and Research FDA News Release. Nov 1, 2019 Statement on new testing results, including low levels of impurities in ranitidine drugs. https://www.fda.gov/news-events/press-announcements/statement-new-testing-results-including-low-levels-impurities-ranitidine-drugs
  7. Retraction Watch Staff Widely Covered Paper on Ranitidine-Cancer Link Retracted. Medscape 2021. June 15 https://www.medscape.com/viewarticle/953118 - Zeng T, Mitch WA Retracted: Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine. Carcinogenesis, Volume 37, Issue 6, June 2016, Pages 625-634 https://academic.oup.com/carcin/article/37/6/625/1744630
  8. Florian J, Matta MK, DePalma R et al Effect of Oral Ranitidine on Urinary Excretion of N-Nitrosodimethylamine (NDMA). A Randomized Clinical Trial. JAMA. Published online June 28, 2021 PMID: 34180947 https://jamanetwork.com/journals/jama/fullarticle/2781670 - White CM, Hernandez AV. Ranitidine and Risk of N-Nitrosodimethylamine (NDMA) Formation. JAMA. Published online June 28, 2021 PMID: 34180953 https://jamanetwork.com/journals/jama/fullarticle/2781671