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Updated: Oct 18, 2025

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Estimated Cancer Risks Associated with Nitrosamine Contamination in Commonly Used Medications

Kate Li1, Karin Ricker1, Feng C Tsai1

  • 1Office of Environmental Health Hazard Assessment (OEHHA), California Environmental Protection Agency, Oakland, CA 94612, USA.

International Journal of Environmental Research and Public Health
|September 28, 2021
PubMed

Insights

Nitrosamine contamination in medications like valsartan, including NDMA and NDEA, poses significant cancer risks. Long-term drug use with these contaminants raises public health concerns due to their carcinogenic properties.

Area of Science:

  • Environmental Health
  • Toxicology
  • Pharmaceutical Science

Background:

  • Nitrosamines are potent carcinogens, with over 30 listed under California's Proposition 65.
  • Recent contamination of drugs for hypertension, heartburn, and diabetes has led to FDA recalls.
  • Key contaminants include N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA), and N-nitroso-N-methyl-4-aminobutyric acid (NMBA).

Purpose of the Study:

  • To estimate the additional cancer risks from NDMA and NDEA contamination in commonly used drugs.
  • To utilize valsartan as a case study for risk assessment.
  • To highlight the public health implications of nitrosamine contamination in pharmaceuticals.

Main Methods:

  • Utilized US FDA reported nitrosamine levels.
  • Incorporated cancer potencies from California's Proposition 65 and US EPA.
  • Applied specific exposure scenarios for risk estimation.

Main Results:

  • Nitrosamine contaminants like NDMA and NDEA share genotoxic and tumorigenic activities.
  • These contaminants exhibit common target tumor sites.
  • Estimates indicate increased cancer risks associated with long-term use of contaminated drugs.

Conclusions:

  • Nitrosamine contamination in pharmaceuticals is a serious public health concern.
  • Long-term exposure to contaminated drugs can elevate cancer risks.
  • Regulatory oversight and monitoring are crucial for drug safety.
Keywords:
cancernitrosaminesrisk assessment

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