U.S. regulators are notifying drug companies that make Metformin, a popular diabetes drug, that they contain high levels of a cancer-causing chemical. According to a Bloomberg news report, the Food and Drug Administration (FDA) discovered N-Nitrosodimethylamine, or NDMA beyond acceptable amounts in some extended-release versions of metformin. The World Health Organization (WHO) classifies NDMA as a possible human carcinogen.
Metformin is a popular drug among those with type 2 diabetes to control high blood sugar. About 21 million prescriptions for the extended-release version were written in the United States last year, according to data compiled by Bloomberg. Some metformin recalls are expected as soon as this week although it wasn’t clear when companies were planning to remove these products from pharmacy shelves. Metformin is made for the U.S. market by a number of drug companies that make generic drugs worldwide.
Problems with NDMA
The FDA first began looking into issues with metformin and NDMA in December after some versions of the drug sold in other countries were discovered to be tainted with NDMA. In February, the agency said it had not found unacceptable levels of NDMA. Metformin would be the third widely used medication in recent years to face recalls related to NDMA.
Back in July 2018, millions of blood pressure pills were recalled after being contaminated with the chemical during the manufacturing process, primarily in factories in India and China. Last month, the FDA initiated a recall of all versions of Zantac (generic name ranitidine), after the agency determined that the chemical makeup of the stomach can cause NDMA to form and increase when stored in high temperatures.
Valisure, an online pharmacy that tests all the drugs it sells, performed an analysis of regular and extended-release metformin and found that of 128 samples, 36% contained unacceptable NDMA levels. Metformin was recalled in Singapore late last year and in Canada earlier this year because of concerns about NDMA contamination.
Product Liability Issues
Drug makers, just like manufacturers of other products, have the responsibility to put products in the markets that are safe for consumers. When contaminated drugs cause adverse side effects, drug manufacturers can be held liable for the damages and losses caused. An experienced pharmaceutical liability lawyer will be able to advise victims and their families to better help understand their legal rights and options.