Four companies have issued recalls of extended-release versions of the type 2 diabetes drug metformin due to unsafe levels of the likely human carcinogen NDMA, short for N-nitrosodimethylamine.
On May 28, the Food and Drug Administration (FDA) issued a press release warning the public that testing of some extended-release versions of metformin tablets from five different manufacturers revealed elevated levels of NDMA. The agency ordered the companies to issue recalls and all but one have obliged to date. The FDA did not reveal the names of the companies with affected products.
However, the recalled metformin products include all lots of extended release metformin hyrochloride tablets made by Apotex Corp., 14 lots by Actavis, one lot by Marksans Pharma Limited, and all lots by Amneal Pharmaceuticals. The fifth company has yet to announce a recall.
NDMA is an environmental contaminant that is often found in meats and water. The FDA says that human consumption of up to 96 nanograms of NDMA is safe for daily consumption, but that sustained higher levels of consumption of the impurity may increase the risk of cancer.
Last fall, NDMA was also detected at elevated levels in Zantac and generic version of the drug containing the active ingredient ranitidine. On April 1, the FDA announced it was calling for the withdrawal of all Zantac and ranitidine products because it determined that levels of NDMA could increase to unsafe levels under normal storage conditions.
Beasley Allen attorneys Frank Woodson and Lisa Courson are actively investigating potential claims involving regular Zantac/ranitidine use 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.