FDA Releases Lab Results of NDMA/Metformin Investigation

The US Food and Drug Administration (FDA) concluded that the levels of N-Nitrosodimethylamine (NDMA)–a likely human carcinogen–are low to undetectable in metformin products the agency has tested to date.

Thus far, no sample of metformin tested by the FDA has exceeded the acceptable daily intake for NDMA, and no metformin recalls have been recommended by the FDA in the United States, the agency said.

The FDA first began investigating NDMA levels in metformin following reports that diabetes drugs outside the United States contained low levels of NDMA, but that these levels fell within the range that is naturally occurring in some foods and in water.

The most recent update can serve as reassurance to health care professionals and patients alike that metformin remains safe for use. In its announcement, the FDA noted that patients prescribed metformin should continue to take the drug for control of their diabetes.

The FDA said it will continue to monitor NDMA in metformin and other drug products.

—Christina Vogt

Reference:
FDA updates and press announcements on NDMA in metformin [press release]. US Food and Drug Administration. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin. February 3, 2020. Accessed February 5, 2020.