Amneal Pharmaceuticals LLC is recalling all lots of extended release metformin tablets — medication used to treat type 2 diabetes — after testing by the Food and Drug Administration (FDA) showed the tablets contained unsafe levels of NDMA, short for N-Nitrosodimethylamine, a probable carcinogen. The recall does not include Amneal’s immediate release metformin tablets.
NDMA is a known environmental contaminant found in water and foods, including meats, dairy products, and vegetables. The FDA has determined that up to 96 nanograms of NDMA per day is safe for daily consumption but that sustained exposure to higher levels could increase the risk of cancer in humans. NDMA has been found in studies to cause the growth of tumors in laboratory animals, according to the U.S. National Library of Medicine.
On April 1, the FDA called for the removal of all heartburn and acid reflux drugs that contain ranitidine, the active ingredient in Zantac, after finding levels of NDMA in Zantac could increase to unsafe levels under normal storage conditions.
On May 28, the FDA issued a press release saying it had detected NDMA at unacceptable levels in several lots of extended-release metformin, and urged five companies to issue recalls of their extended-release metformin products due to health concerns. That same day, Apotex Corp. issued a recall of all its extended-release metformin tablets. The three remaining companies singled out by the FDA have yet to issue recalls.
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 attorney Frank Woodson is 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.