FDA testing metformin for carcinogens
The FDA is testing metformin, a popular drug used to treat type 2 diabetes, for carcinogenic impurities.
Bloomberg was the first to report the news, writing on Dec. 4 that the federal agency, alongside other health regulators around the world, is testing the medication for the probable human carcinogen N-nitrosodimethylamine (NDMA). It’s the latest in a long list of CV drugs that have been thrust under the microscope in the past year, including three popular blood pressure medications.
Zantac, an over-the-counter histamine-2 blocker that’s prescribed to relieve heartburn and acid reflux, and its generic counterparts were also recently pulled from pharmacy shelves after a federal investigation revealed unsafe levels of NDMA in the drugs.
“The agency is in the beginning stages of testing metformin,” an FDA spokesperson told Bloomberg. “However, the agency has not confirmed if NDMA in metformin is above the acceptable daily intake limit of 96 nanograms in the U.S.”
Bloomberg also reported that another major group, the European Medicines Agency, is urging companies to test for high levels of NDMA in metformin. In Singapore, officials have recalled three of 46 locally marketed metformin medicines, citing nitrosamine impurities.
In a statement to Axios, though, former FDA commissioner Scott Gottlieb said the news isn’t all bad.
“There’s likely to be more reports of regulatory efforts to look for these risks, and perhaps additional findings,” he said. “Because we’re now more focused on mitigating these theoretical risks. That’s not necessarily a bad thing. Our expectation of safety and our ability to control for it has increased.”
After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.