Skip to main content

Some Metformin Extended-Release (eg, Fortamet, Glumetza) Products May Contain a Probable Carcinogen

Some metformin hydrochloride extended-release (ER) products, including brand-name Fortament and Glumetza, may contain low concentrations of a probable human carcinogen called N-nitrosodimethylamine (NDMA). N-nitrosodimethylamine is an environmental contaminant found in various foods and water. Concentrations of NDMA barely exceeded amounts found in common foods in preliminary tests conducted by FDA. FDA is evaluating whether these low concentrations pose a risk to patients; however, they are recommending that 5 different manufacturers voluntarily recall their metformin ER products. FDA is working with international regulatory agencies and manufacturers to identify the source of NDMA contamination, and will provide updated information when available.
Meformin is an oral antihyperglycemic medication used for improvement of glucose tolerance in patients with type 2 diabetes and is available by prescription. It helps to lower both basal and post prandial glucose levels, increases peripheral glucose utilization and insulin sensitivity. Patients taking metformin ER should discuss other treatment options with their health care provider before stopping therapy.
Patients and health care providers can report any adverse reaction related to metformin therapy to FDA's MedWatch Program in 1 of 2 ways.

Additional information is available at the following links:

Copyright 2020, Drug Information Service, University of Utah, Salt Lake City, UT.