Estimated Cancer Risks Associated with Nitrosamine Contamination in Commonly Used Medications

Kate Li, Karin Ricker, Feng C. Tsai, ChingYi J. Hsieh, Gwendolyn Osborne, Meng Sun, M. Elizabeth Marder, Sarah Elmore, Rose Schmitz and Martha S. Sandy
Additional contact information
Kate Li: Office of Environmental Health Hazard Assessment (OEHHA), California Environmental Protection Agency, Oakland, CA 94612, USA
Karin Ricker: Office of Environmental Health Hazard Assessment (OEHHA), California Environmental Protection Agency, Oakland, CA 94612, USA
Feng C. Tsai: Office of Environmental Health Hazard Assessment (OEHHA), California Environmental Protection Agency, Oakland, CA 94612, USA
ChingYi J. Hsieh: Office of Environmental Health Hazard Assessment (OEHHA), California Environmental Protection Agency, Sacramento, CA 95812, USA
Gwendolyn Osborne: Office of Environmental Health Hazard Assessment (OEHHA), California Environmental Protection Agency, Oakland, CA 94612, USA
Meng Sun: Office of Environmental Health Hazard Assessment (OEHHA), California Environmental Protection Agency, Sacramento, CA 95812, USA
M. Elizabeth Marder: Office of Environmental Health Hazard Assessment (OEHHA), California Environmental Protection Agency, Sacramento, CA 95812, USA
Sarah Elmore: Office of Environmental Health Hazard Assessment (OEHHA), California Environmental Protection Agency, Oakland, CA 94612, USA
Rose Schmitz: Office of Environmental Health Hazard Assessment (OEHHA), California Environmental Protection Agency, Sacramento, CA 95812, USA
Martha S. Sandy: Office of Environmental Health Hazard Assessment (OEHHA), California Environmental Protection Agency, Oakland, CA 94612, USA

IJERPH, 2021, vol. 18, issue 18, 1-13

Abstract: 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.

Keywords: cancer; nitrosamines; risk assessment (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2021
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