New Testing Prompts New Finding Of NDMA, Cancer Risk In Metformin Products

The US FDA requests several manufacturers recall extended-release metformin based on studies confirming a higher NDMA impurity threshhold; previous testing found no significant risks. 

Close up of Metformin prescription bottle with glucometer and testing strip container.
FDA issues new findings about NDMA in metformin. • Source: Shutterstock

The US Food and Drug Administration is advising that certain extended-release formulations of metformin made by five manufacturers have high levels of the potential carcinogen N-Nitrosodimethylamine (NDMA) and has requested these products be recalled. Earlier evaluations led the agency to conclude these products posed negligible cancer risks.

Valisure, the online pharmacy that challenged the agency's initial test findings, asserts that the FDA continues to underestimate the carcinogenic risks in metformin drugs and needs better testing methods to evaluate these risks

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