A recall of the widely-used diabetes drug metformin was announced by drug maker Apotex, due to possible high levels of N-Nitrosodimethylamine (NDMA), which is believed to cause cancer in people.
Metformin is one of the most commonly prescribed drugs in the United States and is often the first oral medication prescribed for people newly diagnosed with diabetes. According to the Agency for Healthcare Research and Quality, more than 78 million prescriptions for metformin were written in 2017, with extended-release versions of the drug accounting for about one-quarter of those prescriptions.
The recall for all lots of metformin hydrochloride extended-release tablets 500 mg from Apotex comes after one lot tested by the U.S. Food and Drug Administration had higher NDMA levels than allowed by the FDA.
This latest recall stems from a recent series of tests that revealed unacceptably high levels of N-nitrosodimethylamine, a probable human carcinogen, in several lots of metformin extended-release products.
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