[2/3/2020] The U.S. Food and Drug Administration posted laboratory results showing N- Nitrosodimethylamine (NDMA) levels in some metformin products approved in the U.S. FDA has determined that the levels of NDMA in metformin products tested range from not detectable to low levels. To date, no sample of metformin that FDA has tested exceeds the acceptable daily intake for NDMA. FDA has not recommended metformin recalls in the U.S.
Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes. Patients should continue taking metformin to keep their diabetes under control. It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.
FDA plans to post the methods used in laboratory testing of metformin in the near future. FDA is also collaborating with international regulators to share testing results for metformin, along with testing results for other drugs.
FDA will continue to monitor NDMA in metformin, along with other drugs products, and will provide timely updates of new developments, including product recalls. For more information about NDMA, visit FDA’s nitrosamines webpage.
FDA encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178
- LC-HRMS method: an LC-MS method for the detection of NDMA in metformin drug substance and drug products.
- Additional test methods will be posted when available.