The U.S. Food and Drug Administration (FDA) and other drug regulatory bodies have been investigating diabetes drug metformin for possible contamination with a carcinogenic called N-nitrosodimethylamine (NDMA).
Earlier this year, the FDA recalled a few lots of heartburn drug Zantac (ranitidine) because they were found to be tainted with NDMA. The agency added that the levels of contamination in Zantac “are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”
European Medicines Agency (EMA) officials said they have asked pharma companies to test metformin across Europe for a possible NDMA contamination because they found some metformin products tainted with NDMA in Singapore.
Health Sciences Authority (HSA) of Singapore recalled three lots of metformin products, according to EMA. The agency described the risk as very low so far and advised patients to continue taking the medication as the risk of uncontrolled diabetes is dangerous.
The Canadian drug regulatory body said it was unaware of any metformin products containing NDMA above acceptable limits in Canada. However, it said the officials have been working closely with internal drug regulatory bodies on the current issue.
Metformin is one of the most commonly prescribed drugs for people with type 2 diabetes.
Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock said, “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.” “FDA recommends recalls as appropriate if high levels of NDMA are found,” she added.
