FDA Update on Investigation of NDMA in Metformin Products

The FDA is continuing to investigate the presence of N-Nitrosodimethyalmine (NDMA) in metformin products in the United States, following metformin recalls due to the carcinogenic impurity in products outside of the country.

On February 3, the agency posted the results of its laboratory analysis showing NDMA levels in some samples of the metformin products it tested. Overall, the levels of NDMA found in metformin ranged from “not detectable to low levels.” According to the agency, no sample of metformin that was tested by the FDA exceeded the acceptable daily intake of NDMA.

In December, regulatory agencies outside of the United States recalled some metformin drugs due to low levels of the impurity, prompting FDA officials to test samples of metformin sold in the United States. To date, the FDA has not recommended metformin recalls in the United States.

Related: FDA Investigating NDMA in Metformin

According to the FDA, consuming up to the acceptable daily intake limit, 0.096 micrograms, of NDMA per day is considered reasonably safe for humans, based on lifetime exposure. In metformin products that did have low levels of NDMA, the FDA noted that levels were similar to what you would expect to be exposed to “if you ate foods like grilled or smoked meats.”

The agency is collaborating with international regulators to share testing results for metformin, along with testing results for other drugs.

The laboratory results can be found on the FDA’s website.

References:

1. FDA posts laboratory testing results for NDMA levels in metformin [statement]. FDA’s website. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin. Accessed February 4, 2020.