The Food and Drug Administration (FDA) is investigating whether metformin sold in the U.S. contains a possible carcinogen.
The U.S. Food and Drug Administration has been investigating the presence of impurities, called nitrosamines, such as N-Nitrosodimethylamine (NDMA) in some types of drugs.
Over the past year and a half, several other drug products including angiotensin II receptor blockers (ARBs) and ranitidine, commonly known as Zantac, have been found to contain small amounts of nitrosamines.
According to a statement from Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, the FDA is aware that some metformin diabetes medicines in other countries were reported to have low levels of NDMA.
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.
If high levels are found, the agency will recommend recalls and will provide timely updates to patients and health care professionals.
The FDA statement indicates patients should continue taking metformin to keep their diabetes under control in the meantime.
- U.S. Food and Drug Administration. (2019, Dec. 5). Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on impurities found in diabetes drugs outside the U.S., Retrieved Dec 9, 2019, from https://www.fda.gov/news-events/press-announcements/statement-janet-woodcock-md-director-fdas-center-drug-evaluation-and-research-impurities-found