The U.S. Food and Drug Administration has launched an investigation to determine whether the diabetes drug metformin contains dangerously elevated levels of the carcinogen N-nitrosodimethylamine (NDMA). This FDA metformin probe is part of a larger movement to examine a wide spectrum of medications for unsafe levels of NDMA contamination.
In early December, the FDA investigation began after similar probes had been launched by the European Unions’ EMA into a range of drugs including the heartburn drug Zantac. During the announcement of the probe, FDA officials reassured consumers that the FDA had found NDMA levels in Zantac approximately equal to those found in grilled or smoked meat.
The FDA does expect to find trace amounts of NDMA as it is present in almost all food and water, but elevated levels of the chemical could pose a health risk to consumers. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, told consumers, "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."
There has been one investigation so far that has found elevated NDMA contamination in metformin. That was an investigation in Singapore that recalled three out of 46 metformin samples tested. Additionally, despite the FDA metformin probe’s actions, regulatory agencies have unanimously agreed that metformin is a vital medication for controlling the early stages of type 2 diabetes and it is more dangerous for patients to stop taking the drug.