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.
“Now that we have identified some metformin products that do not meet our standards,…
…we’re taking action, “said Patrizia Cavazzoni, M.D., acting director of the agency’s Center for Drug Evaluation and Research, in a press release. “As we have been doing since this impurity was first identified, we will communicate as new scientific information becomes available and will take further action, if appropriate.”
NDMA is an environmental contaminant that’s found in water and foods, including meats, dairy products, and vegetables.
Metformin hydrochloride extended-release tablets are prescribed to be used along with diet and exercise to improve blood sugar control in adults and children age 10 and older with type 2 diabetes.
NDMA contamination triggered numerous recalls of widely-used heart medicines last year.
All manufacturers of metformin-containing ER products are being asked to evaluate the risk of excessive NDMA in their products and to test each batch before releasing it into the U.S. market. If testing shows NDMA above the acceptable intake limit, the manufacturer should inform the agency and halt release of the batch.
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