FDA Has No Plans to Recall Diabetes Drug Metformin

“To date, no sample of metformin that FDA has tested exceeds the acceptable daily intake for NDMA.”


The U.S. Food and Drug Administration (FDA) has said it has no plans to recall any medications containing metformin after tests failed to show any evidence of a cancer impurity called N-nitrosodimethylamine (NDMA).

Metformin is the first-line oral medication prescribed to treat type 2 diabetes, especially in overweight people.

The FDA said the medications containing metformin did not show NDMA at levels that would cause concern.

The agency started testing samples of metformin for NDMA in December 2019. https://www.myhealthyclick.com/fda-investigates-diabetes-drug-metformin-for-possible-carcinogen/

In the last couple of years, the FDA found NDMA contamination in certain blood pressure and heartburn medications, recalling them.

The FDA started investigating metformin after three versions of the drug in Singapore were recalled and the European Medicines Agency (EMA) requested the drugmakers to test their drugs for NDMA contamination.

This week, the FDA published lab results of some metformin products in which NDMA levels ranged from “not detectable to low.”

The FDA said, “To date, no sample of metformin that FDA has tested exceeds the acceptable daily intake for NDMA. FDA has not recommended metformin recalls in the US.”

In the United States, over 30 million people have diabetes, of which, 90 to 95 percent of people have type 2 diabetes.

Metformin is the fourth most-prescribed diabetes drug in the United States.

The U.S. health agency said, “Patients should continue taking metformin to keep their diabetes under control. It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.”

The FDA will post the methods used in the lab testing of metformin soon. It has been working with international drug regulatory bodies to share testing results of metformin products, as well as other drugs. The agency said it would continue monitoring NDMA in metformin and other drugs. It will also provide timely updates of developments and even product recalls.