In June, the FDA announced that five pharmaceutical companies would be recalling certain metformin drugs (ERM) that are used to treat type 2 diabetes. The announcement follows their initial recall recommendation after testing of ERM revealed “unacceptable levels” of N-Nitrosodimethylamine (NDMA), a human carcinogen. Continue reading below to learn more.
What is NDMA?
NDMA is classified as a probable human carcinogen by the World Health Organization (WHO). N-nitrosamines are naturally occurring environmental toxins that generally form “when a secondary or tertiary amine reacts with a nitrosating agent.” Due to the fact that it is a carcinogen, NDMA has been associated with cancers of the liver, kidney, bladder, pancreas, stomach, colon, blood, and ovaries. It has also been linked to non-Hodgkin’s lymphoma and multiple myeloma.
What is Metformin?
Metformin is a prescription drug that aids high blood sugar regulation in patients who have type 2 diabetes. This disease impacts 1 in 10 Americans. The drug has been widely prescribed and considered to be safe on the market for managing diabetes. It comes in an extended release version to be taken once a day or an immediate release formulation to be taken twice a day.
The Recall Process
Before the FDA announcement to recall metformin, other countries began to monitor the safety of the drug. However, the FDA’s attention was caught by a private Connecticut-based laboratory company, Valisure, that observed more than 10 times the accepted level of NDMA in several batches of metformin. Further research led the company to petition the FDA to take metformin off the U.S. market. This led to the eventual recall.
The makers named in the recall include Apotex Corp., Amneal Pharmaceuticals, Marksans Pharma Limited’s Time-Cap Labs, Inc., Lupin Pharmaceuticals Inc., and Teva Pharmaceuticals USA< INc.’s Actavis Generics. These companies would be notifying wholesalers, distributors, and retailers to arrange for the return of the products. The FDA also asked all companies beyond these that manufacture the drug to carefully monitor its production and evaluate whether they contain NDMA above the acceptable intake levels. They recommend patients already using recalled ERM to continue taking it “until a doctor or pharmacist gives them a replacement or a different treatment option” to avoid any adverse effects from suddenly stopping their treatment.
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