Tinjauan atas N-Nitrosodimethylamine (NDMA)
DOI:
https://doi.org/10.55175/cdk.v47i10.555Keywords:
Agen karsinogenik, NDMA, N-NitrosodimethylamineAbstract
Beberapa jenis obat disinyalir telah terkontaminasi NDMA dalam konsentrasi yang berbeda-beda. N-Nitrosodimethylamine (NDMA) adalah salah
satu senyawa golongan karsinogen potensial, N-nitrosamine. NDMA, sebagai senyawa organik terbentuk secara alami dan sebagai produk sampingan industri, dapat tersebar di udara, air, dan tanah. Dalam kondisi tertentu NDMA bisa terbentuk di dalam tubuh makhluk hidup, termasuk manusia, dan terdegradasi secara alami. NDMA disinyalir dapat mengganggu kesehatan dan meningkatkan risiko pertumbuhan neoplasi, tergantung pada konsentrasi dan durasi paparan. Ambang batas keamanan kadar NDMA telah diatur dalam berbagai peraturan.
Several drugs were thought to have been contaminated by NDMA at different concentration. N-Nitrosodimethylamine (NDMA) is a compound of potential carcinogen group, N-nitrosamine. NDMA is formed naturally and as industrial byproducts, can be disseminated in air, water and soil. In certain condition, NDMA can be formed inside living organism including human, and will be naturally degraded. NDMA might cause health disturbance and increase risk of neoplastic growth, depending on concentration and exposure duration. Safety level of NDMA is stated on several regulations
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References
Minister of Public Works and Government Services Environment and Health Canada. Priority substances list assessment report: N-nitrosodimethylamine (NDMA) [Internet]. 2001 [cited 2019 November 26]. Available from: https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/ewh-semt/alt_formats/hecs-sesc/pdf/pubs/contaminants/psl2-lsp2/nitrosodimethylamine/ndma-eng.pdf
United States Environmental Protection Agency (EPA). Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA) [Internet]. 2014 [cited 2019 November 26]. Available from: https://www.epa.gov/sites/production/files/2014-03/documents/ffrrofactsheet_contaminant_ndma_january2014_final.pdf
World Health Organization (WHO). N-Nitrosodimethylamine. Geneva, World Health Organization, Guidelines for Drinking-Water Quality (3rd edition including 1st and 2nd addenda) [Internet]. 2008 [cited 2019 November 26]. Available from: https://www.who.int/water_sanitation_health/dwq/chemicals/ndmasummary_2ndadd.pdf?ua=1
Agency for Toxic Substances and Disease Registry (ATSDR). Toxicological profile for n-nitrosodimethylamine. Atlanta, GA: U.S. Department of Health and Human Services, Public Health Service [Internet]. 1989 [cited 2019 November 26]. Available from: https://www.atsdr.cdc.gov/toxprofiles/tp141.pdf
Liteplo RG. Meek ME. Windle W. Concise International Chemical Assessment Document 38 – N-Nitrosodimethylamine. United Nations Environment Programme, Labour Organization, World Health Organization; 2002 .p. 1-46
Loh YH, Jakszyn P, Luben RN, Mulligan AA, Mitrou NP, Khaw KT. N-nitroso compounds and cancer incidence: the European Prospective Investigation into Cancer and Nutrition (EPIC)–Norfolk Study. The American Journal of Clinical Nutrition. 2011;93:1053–61
Chowdhury S. N-Nitrosodimethylamine (NDMA) in food and beverages: A comparison in context to drinking water. Human and Ecological Risk Assessment: An International Journal. 2014;20:1291–312
Terracini B, Palestro G, Gigliardi MR, Montesano G, Montesano R. Carcinogenicity of dimethylnitrosamine in Swiss mice. Br J Cancer 1996;20:871–6
Velo-Gala I, Farre MJ, Radjenovic J, Gernjak W. N-Nitrosodimethylamine (NDMA) degradation by the ultraviolet/ peroxodisulfate process. Environmental Science & Technology Letters. 2019;6(2):106-11.
Mitch WA, Sharp JO, Rhodes RR, Valentine RL, Alvarez-Cohen L, Sedlak DL. N-Nitrosodimethylamine (NDMA) as a drinking water contaminant: A review. Environmental Engineering Science 2003;20(5):389-404
Food and Drugs Administration. FDA updates and press announcements on angiotensin II receptor blocker (ARB) recalls (valsartan, losartan, and irbesartan). Drug safety and availability [Internet]. 2019 [cited 2019 December 1]. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-pressannouncements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan
Food and Drugs Administration. DA updates and press announcements on NDMA in zantac (ranitidine). drug safety and availability [Internet]. 2019 [cited 2019 December 1]. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine
Badan Badan Pengawas Obat dan Makanan. Penjelasan Badan Pom RI tentang perkembangan lebih lanjut penarikan produk ranitidin yang terkontaminasi N-Nitrosodimethylamine (NDMA). Klarifikasi Badan POM [Internet]. 2019 [cited 2019 December 1]. Available from: https://www.pom.go.id/new/view/more/klarifikasi/103/PENJELASAN-BADAN-POM-RI--TENTANG-PERKEMBANGAN-LEBIH-LANJUT-PENARIKAN-PRODUK-RANITIDIN--YANG-TERKONTAMINASI-NNITROSODIMETHYLAMINE--NDMA-.html
Food and Drugs Administration. Questions and answers: NDMA impurities in ranitidine (commonly known as Zantac) drug safety and availability [Internet]. 2019 [cited 2019 December 1]. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-ndma-impurities-ranitidine-commonlyknown-zantac
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