INDIANAPOLIS (WTHR) – After the presence of a carcinogen prompted recalls of several blood pressure medications and Zantac, the FDA is now looking into the possibility of the same carcinogenic impurity in a widely prescribed diabetes drug.
Low levels of N-nitrosodimethlyamine (NDMA) have been found in metformin medicines in other countries. The medication is widely used to treat diabetes.
Some regulatory agencies outside of the U.S. have already started recalling metformin, but there are not currently any active metformin recalls in the U.S.
According to a release by the FDA, the levels of NDMA seen in metformin drugs abroad are within the range that is naturally occurring in food and water.
The FDA is currently investigating whether the metformin used in the U.S. contains NDMA, and if it is present in levels higher than the acceptable daily intake.
NDMA is a common contaminant found in water, dairy products, vegetables and foods like cured and grilled meets. It does not cause harm when ingested at low levels, but may increase risk of cancer if one is exposed to it above acceptable levels over long periods of time.
Metformin is a prescription drug used to control high blood sugar in type 2 diabetes patients.
The FDA is urging people who use metformin not to discontinue taking the drug without talking to a health care professional
“These investigations take time,” Janet Woodcock, director of FDA’s center for Drug Evalaliatoin and Research said. “We understand that these issues affect patients’ health and well-being in many ways, and the FDA’s goal is to provide patients and health care providers as much clarity and as many answers as possible to inform their health care decisions.”