Estimated Cancer Risks Associated with Nitrosamine Contamination in Commonly Used Medications

Autor: Feng C. Tsai, Kate Li, M. Elizabeth Marder, Karin Ricker, Martha S. Sandy, Sarah Elmore, Meng Sun, Rose Schmitz, Gwendolyn Osborne, ChingYi J. Hsieh
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: International Journal of Environmental Research and Public Health
International Journal of Environmental Research and Public Health, Vol 18, Iss 9465, p 9465 (2021)
ISSN: 1660-4601
1661-7827
Popis: Many nitrosamines are potent carcinogens, with more than 30 listed under California’s Proposition 65. Recently, nitrosamine contamination of commonly used drugs for treatment of hypertension, heartburn, and type 2 diabetes has prompted numerous Food and Drug Administration (FDA) recalls in the US. These contaminants include the carcinogens NDMA (N-nitrosodimethylamine) and NDEA (N-nitrosodiethylamine) and the animal tumorigen NMBA (N-nitroso-N-methyl-4-aminobutyric acid). NMBA and NDEA are metabolically and/or structurally related to NDMA, an N-nitrosomethyl-n-alkylamine (NMA), and 12 other carcinogenic NMAs. These nitrosamines exhibit common genotoxic and tumorigenic activities, with shared target tumor sites amongst chemicals and within a given laboratory animal species. We use the drug valsartan as a case study to estimate the additional cancer risks associated with NDMA and NDEA contamination, based on nitrosamine levels reported by the US FDA, cancer potencies developed by California’s Proposition 65 program and the US Environmental Protection Agency (EPA), and specific exposure scenarios. These estimates suggest that nitrosamine contamination in drugs that are used long-term can increase cancer risks and pose a serious concern to public health.
Databáze: OpenAIRE