The U.S. Food and Drug Administration (FDA) is investigating whether a drug used to treat diabetes is contaminated with traces of a chemical thought to increase the risk of developing cancer.
The FDA is aware that some metformin diabetes medicines in other countries were reported to have low levels of NDMA.
Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes.
“The FDA has been investigating the presence of genotoxic impurities, called nitrosamines, in some types of drugs,” said Director of Center for Drug Evaluation and Research Janet Woodcock M.D. in a press release.
“Over the past year and a half, several drug products including angiotensin II receptor blockers (ARBs) and ranitidine, commonly known as Zantac, have been found to contain small amounts of nitrosamines such as N-Nitrosodimethylamine (NDMA).”
According to the press release, while the FDA is aware that some regulatory agencies outside the U.S. may be recalling some metformin drugs, there are no metformin recalls affecting the U.S. market at this time.
The FDA is investigating whether metformin in the U.S. market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms.
“The agency will also work with companies to test samples of metformin sold in the U.S. and will recommend recalls as appropriate if high levels of NDMA are found. If as part of our investigation, metformin drugs are recalled, the FDA will provide timely updates to patients and health care professionals.”
For more on the investigation, click here
“The FDA will communicate any information we have scientifically confirmed to ensure the public knows as much as possible as soon as possible,” said Woodcock.