FDA Continues Recollects of Metformin ER
If you have type 2 diabetes and are taking the extended-release (ER) form of metformin to control your blood sugar levels, you should know that some metformin ER products continue to be available from the US Food and Drug due to Administration (FDA) will recall contaminants that may be higher than acceptable.
The impurity in question is N-nitrosodimethylamine (NDMA). It can be found in some foods and beverages, but the National Center for Biotechnology Information said it is also used in research to cause tumors to grow in animals and that “it is reasonably believed to be a human carcinogen is “- which means it can cause cancer.
In May 2020, the FDA announced that multiple batches of metformin ER had found higher NDMA levels to be acceptable. The companies that manufactured these lots of metformin ER have been asked to voluntarily recall them. The FDA noted that NDMA was not found in any metformin immediate release (IR) product.
The FDA continues to issue recalls of Metformin ER products. The latest update will be released on October 5th. The agency added 77 lots to the recall list. Medical Daily asked the FDA why the recalls continued nearly five months after the FDA first confirmed that some metformin ER lots were found to have higher than acceptable levels of NDMA.
The FDA responded in an email that they had asked all drug companies that make Metformin ER to test their “compromised” products before they were placed on the consumer market. If the NDMA value is found to be above the FDA accepted limit, the drug company must notify the FDA and not place the batch on the market.
NDMA is used in some manufacturing processes, but can form chemically as a by-product in some drug manufacturing processes. It was the subject of a major recall last year because it was found in some amounts of ranitidine or Zantac, a drug used to treat heartburn. In early 2020, the FDA also recalled some blood pressure medications because of the presence of NDMA.
The agency said NDMA can be introduced into a medicine during the manufacturing process, packaging of the medicine, or storage of the medicine. The FDA has denied any current metformin ER deficiency, according to the email sent to Medical Daily.
Take them home
“Patients taking the recalled ER-metformin should continue to take it until a doctor or pharmacist gives them a replacement or other treatment option. It could be dangerous for patients with type 2 diabetes to stop taking metformin without speaking to their doctor, ”the FDA wrote.
The list of recalled Metformin products can be found here.