Skip to Main Content

An online pharmacy is calling for U.S. regulators to recall batches of the metformin diabetes medicine made by nearly a dozen companies after its tests found excessive amounts of a possible carcinogen, the same substance that has already prompted widespread recalls of blood pressure and heartburn pills. Metformin is used to control high blood sugar levels in people with Type 2 diabetes.

In a petition filed with the Food and Drug Administration, Valisure stated that independent laboratory testing detected NDMA above the daily acceptable intake level in 16 batches of the diabetes treatment made by 11 different manufacturers. And several batches contained more than 10 times the acceptable limit, with significant variations seen in batches made in some cases by the same company.

advertisement

NDMA is an organic chemical that was once used to make rocket fuel and is an unintended byproduct of certain chemical reactions. The World Health Organization and the U.S. Environmental Protection Agency consider the impurity to be a possible carcinogen, and its appearance in a growing list of medications has prompted regulators and manufacturers to scramble to understand the reasons.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!

GET STARTED

Comments are closed.