NDMA has attracted wide attention as being highly hepatotoxic and a known carcinogen in laboratory animals.
[6] The United States Environmental Protection Agency (EPA) determined that the maximal admissible concentration of NDMA in drinking water is 7 ng/L.
[8] As of July 2020, the EPA has not set a regulatory maximal contaminant level (MCL) for drinking water.
The limits for nitrosamines in medicines have been set using internationally agreed standards (ICH M7(R1)) based on lifetime exposure.
[15] In the laboratory, NDMA can be synthesised by the reaction of nitrous acid with dimethylamine: The mechanism of its carcinogenicity involves metabolic activation steps resulting in the formation of methyldiazonium, an alkylating agent.
In 1978, a teacher in Ulm, Germany, was sentenced to life in prison for trying to murder his wife by poisoning jam with NDMA and feeding it to her.
[16][17] That same year, Steven Roy Harper spiked lemonade with NDMA at the Johnson family home in Omaha, Nebraska.
[22] In December 2019, the FDA began testing samples of the diabetes drug metformin for NDMA.
[23] The FDA announcement followed a recall of three versions of metformin in Singapore, and the European Medicines Agency's request that manufacturers test for NDMA.
[28][32][33][34][35] In August 2021, a class 2 medicines recall was issued for a batch of metformin hydrochloride 500 mg/5ml Oral Solution from Rosemont Pharmaceuticals Limited, which was first distributed in December 2020, due to the identification of higher than acceptable levels of NDMA.
[36] A study has shown that NDMA perturbs arginine biosynthesis, mitochondrial genome maintenance, and DNA damage repair in yeast.