FDA recalls multiple lots of extended-release metformin due to contamination
The FDA is pushing for a voluntary recall of certain lots of extended-release (ER) metformin after lab tests revealed unacceptable levels of N-nitrosodimethylamine (NDMA).
Metformin is a popular prescription drug for type 2 diabetes. NDMA is a common contaminant, and low traces can be found in water and a variety of foods. Ingesting too much NDMA has been associated with increasing a person’s risk of cancer.
The voluntary recall does not apply to immediate release metformin products.
“The FDA has strict standards for safety, effectiveness and quality, and the agency makes every effort based on science and data to help keep the U.S. drug supply safe,” Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “We understand that patients may have concerns about possible impurities in their medicines, and want to assure the public that we have been looking closely at this problem over many months in order to provide patients and health care professionals with clear and accurate answers. Now that we have identified some metformin products that do not meet our standards, we’re taking action. 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.”
Patients affected by the recall should continue taking the medication until they can receive a replacement prescription, according to the FDA. Also, healthcare providers can continue to prescribe metformin when appropriate.
In all, five pharmaceutical firms will be contacted about the voluntary recall. Toronto-based Apotex is the only firm currently listed on the FDA’s website. The company agreed to the recall, and its announcement is available online.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.