Traces of the probable carcinogen nitrosamine impurity N-Nitrosodimethylamine, or NDMA, have been found in the first-line type 2 diabetes drug metformin outside the United States, prompting an investigation by the U.S. Food and Drug Administration (FDA) to determine if metformin sold in the U.S. contains any NDMA and whether the impurity is above the daily intake limit of 96 nanograms.
“The agency will also work with companies to test samples of metformin sold in the U.S. and will recommend recalls as appropriate if high levels of NDMA are found,” said Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
Metformin is a prescription drug used as a first-line treatment to control high blood sugar in type 2 diabetics. NDMA is a common contaminant found in water and foods including cured and grilled meats, dairy products and vegetables.
“Everyone is exposed to NDMA,” Woodcock said. It is not believed that ingesting low levels of NDMA causes harm, she said. However, “genotoxic substances such as NDMA may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time,” she said, adding, “but a person taking a drug that contains NDMA at-or-below the acceptable daily intake limit every day for 70 years is not expected to have an increased risk of cancer.”
NDMA was identified a year and a half ago in several active drug ingredients in medications used to treat high blood pressure and heart failure, known as angiotensin II receptor blockers, or ARBs. Earlier this year, NDMA was also found in both over-the-counter and prescription heartburn drugs containing ranitidine, such as Zantac. Both discoveries resulted in numerous recalls.
“Our investigations, including our current investigation of metformin, take into account the medical necessity of the drug, how many Americans may take it, and whether there may be alternative treatments available,” Woodcock said. “The American public can expect that we will act quickly to address any issue as soon as we find out about it.”
Beasley Allen attorney Frank Woodson is actively investigating potential claims of NDMA involving regular Zantac/ranitidine use that may have led to cancer of the stomach, colon, intestines, kidneys, bladder or pancreas. If you or a loved one may have been affected, please contact us.