Late last year, the FDA put out a warning against the diabetes drug metformin after claims were made of low-level cancer-causing contaminants in the product.
Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes.
“The U.S. Food and Drug Administration has been investigating the presence of genotoxic impurities, called nitrosamines, in some types of drugs. 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). During this time, there has been an ongoing investigation into the presence of nitrosamines in other drug products. This effort is focused on ensuring the drugs used by Americans continue to meet strict quality standards,” stated the FDA in an official press release on Dec. 5, 2019.
Back in late Nov., reports were made that some metformin diabetes medicines in other countries had found to contain low levels of NDMA.
Now, after the FDA completed testing, their findings say that the type 2 diabetes drug is within the safe range for use.
“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.,” the FDA said in a recent statement.
Patients should continue taking metformin to keep their diabetes under control. It could be dangerous for patients with this severe condition to stop taking their metformin without first talking to their health care professionals.
FDA has posted the methods used in laboratory testing of metformin. FDA is also collaborating with international regulators to share testing results for metformin, along with testing results for other drugs.
They 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.
The FDA also strongly 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.
“Protecting patients is the FDA’s highest priority, and Americans can be confident in the quality of the products the agency approves. We are patients too, and we’re committed to maintaining our high standards for quality, safety and efficacy for all drugs we, our families, friends, colleagues and millions of fellow Americans rely on for their health,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research.
