…we’re taking action, “said Patrizia Cavazzoni, M.D., acting director of the agency’s Center for Drug Evaluation and Research, in a press release. “As we have been doing since this impurity was first identified, we will communicate as new scientific information becomes available and will take further action, if appropriate.”
NDMA is an environmental contaminant that’s found in water and foods, including meats, dairy products, and vegetables.
Metformin hydrochloride extended-release tablets are prescribed to be used along with diet and exercise to improve blood sugar control in adults and children age 10 and older with type 2 diabetes.
NDMA contamination triggered numerous recalls of widely-used heart medicines last year.
All manufacturers of metformin-containing ER products are being asked to evaluate the risk of excessive NDMA in their products and to test each batch before releasing it into the U.S. market. If testing shows NDMA above the acceptable intake limit, the manufacturer should inform the agency and halt release of the batch.