Several companies have initiated recalls of extended release versions of the first-line type 2 diabetes treatment metformin due to unsafe levels of N-nitrosodimethylamine (NDMA), a probable human carcinogen.
On May 28, the Food and Drug Administration (FDA) informed the public that testing had revealed unacceptable levels of NDMA in some extended-release metformin products. The agency urged five companies to recall affected products. Recalls were initiated by the following manufacturers: Granules Pharmaceuticals, Lupin Pharmaceuticals, Avkare (repackager for Amneal), PD-Rx Pharmaceuticals (repackager for Amneal), PD-Rx Pharmaceuticals (repackager for Marksans), The Harvard Drug Group (repackager for Apotex), and Preferred Pharmaceuticals (repackager for Marksans).
The FDA has since created a searchable list of all recalled extended-release metformin products that includes manufacturer name, NDC numbers, lot numbers, and expiration dates for all affected products.
NDMA is a known environmental contaminant that is found in some meats, dairy products, and vegetables. The FDA considers it safe to consume up to 96 nanograms of NDMA per day based on lifetime exposure. But, sustained higher levels of NDMA exposure may increase a person’s risk of cancer. Some cancers that may be linked to NDMA ingestion include stomach, small intestine, kidney, colorectal, esophageal, prostate, and pancreatic cancers, as well as leukemia, non-Hodgkin’s lymphoma, and multiple myeloma. However, no studies have been published that can identify how great a person’s risk of developing cancer is or the specific tumors NDMA exposure may cause.
In April, the FDA recommended the removal of all heartburn medications that contain ranitidine, the active ingredient in Zantac, because levels of NDMA in Zantac were found to increase to unsafe levels under normal storage conditions.
The FDA is not recommending that anyone who used Zantac or affected metformin products undergo any special cancer screenings. However, patients who have had cancer in the past may want to discuss their concerns with their doctors.
Beasley Allen attorneys Frank Woodson and Lisa Courson are actively investigating potential claims involving regular Zantac/ranitidineuse that may have led to cancer of the stomach, colon, intestines, kidneys, or pancreas. If you or a loved one may have been affected, please contact us. Beasley Allen is not currently taking claims related to metformin.