FDA finds likely carcinogen in common diabetes drug metformin. Will recalls follow?

FDA Lab
The FDA declined to comment on whether metformin recalls were likely. (FDA)

On the hunt for drugs contaminated with a likely carcinogen, the FDA initially tested and cleared generic diabetes med metformin. But now, after an independent lab challenged those findings, the FDA has identified that carcinogen in the widely used med, and broad recalls could be in the offing. 

The FDA found carcinogen contamination in extended-release formulations of metformin, supporting outside laboratory Valisure's findings in early March, a spokesman said Thursday. 

Tested lots of extended-release metformin showed levels of N-Nitrosodimethylamine (NDMA)—a likely human carcinogen that's led to recalls of "sartan" blood pressure drugs and the heartburn remedy Zantac—above acceptable limits, the FDA said. Those elevated levels weren't found in samples of metformin's immediate-release formula. 

Featured Webinar

How to Streamline Your Clinical Research Organization's Processes End to End

Learn how implementing one platform leads to data consistency and ultimately facilitate faster clinical trials while reducing overall trial costs, leave behind spreadsheets and home-grown tools for a predictable trial and the ability to forecast unit delivery resulting in the optics you need to ensure a successful trial, and hear experts share industry trends of what is affecting the Clinical Research Organization industry today.

The FDA is contacting companies that sell extended-release metformin with NDMA levels that surpass the acceptable limit, a spokesman said. The agency declined to comment on whether recalls are likely for those products. 

The agency's newest findings come months after the FDA found no instances of NDMA contamination during generic metformin testing. 

RELATED: Testing lab challenges FDA findings that carcinogens in metformin do not exceed acceptable levels

Suggested Articles

Three facts about how distributors are managing in-demand inventory.

Novartis’ latest campaign with a celebrity dance partner asks people to bust a move to raise awareness around sickle cell anemia and therapy Adakveo.

Purdue has reached an $8 billion settlement with the U.S. government to settle criminal and civil charges for its role in the U.S. opioid crisis.