Levels of N-Nitrosodimethylamine (NDMA) in some metformin products approved for distribution in the US ranged from “not detectable to low,” based on laboratory test results announced by the Food and Drug Administration (FDA).
The investigation into metformin products produced in the US was prompted by reports of low NDMA levels found in the antidiabetic agent outside of the US. To date, the FDA has not recommended a recall of metformin products in the US due to the relatively low levels of NDMA identified in testing. According to the Agency, these levels were “similar to the levels you would expect to be exposed to if you ate foods like grilled or smoked meats.”
Moreover, the Agency has not identified a sample of metformin that has exceeded the acceptable daily intake for NDMA. Laboratory results for the tested metformin products can be found here. The Agency will continue to monitor NDMA in metformin as well as other drug products.
Metformin, a biguanide, is indicated to improve glycemic control in patients with type 2 diabetes, as an adjunct to diet and exercise.
Additional information regarding NDMA can be found on the FDA’s nitrosamine impurities webpage. Healthcare professionals and patients are encouraged to report any adverse events associated with these products to the FDA’s MedWatch Program.
For more information visit fda.gov.