Metformin is a popular drug used to control blood sugar levels in individuals with type 2 diabetes. Tests revealed high levels of a probable carcinogen known as NDMA in the U.S. supply of metformin. The online pharmacy that conducted the tests requested that the U.S. Food and Drug Administration (FDA) investigate contaminated Metformin and initiate a recall of the drug.

What is Metformin?

Metformin is an oral medication used in conjunction with diet and exercise to reduce blood sugar levels in type II diabetics.  Proper control of high blood sugar may prevent kidney damage, blindness, and nerve problems, and lessen the risks of heart attack and stroke.

What is Happening with Metformin?

Online pharmacy, Valisure, has found NDMA in sixteen different batches of Metformin manufactured by eleven drug companies. NDMA is a type of nitrosamine that has been classified as a probable human carcinogen. The batch produced by Amneal Pharmaceuticals Inc. contained sixteen times the acceptable daily limit of NDMA.  The contamination of Metformin may occur as a result of production, storage, or as a feature of the drug itself.

Following requests by Valisure to investigate the drug, in December the FDA reported that it was testing samples of Metformin sold in the United States.  The FDA’s tests detected low levels of NDMA in several batches of Metformin with none of those samples exceeding the acceptable limit of 96 nanograms per day. It is not clear why Valisure and the FDA obtained different results in their testing.

The FDA declined to recall Metformin based on its data despite recalls in Singapore and Canada. The World Health Organization and the International Agency for Research on Cancer have classified Metformin as “probably carcinogenic to humans.”

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