Diabetes Drug Recalled Due to High Levels of Substance that 'Could Cause Cancer,' FDA Says
A drug commonly used to treat type 2 diabetes has been recalled due to cancer concerns.
This week the Food and Drug Administration announced that Marksans Pharma Limited has expanded its voluntary recall of metformin hydrochloride sustained release tablets. It has been determined that an additional 76 unexpired lots may contain NDMA levels - classified by the FDA as a "probable human carcinogen (a substance that can cause cancer)" - in excess of acceptable daily levels.
The recall applies to metformin tablets in packs of 500 mg and 750 mg, both cream-colored and embossed with either “101” or “102” on one side and plain on the other. Please visit the FDA website for more information.
FDA metformin hydrochloride prolonged-release tablets
While the FDA does not know how long patients may have been exposed to higher levels of NDMA, they do not believe that "short-term exposure" would "increase the risk of cancer".
They also say the recall was initiated "out of caution" and the pharmaceutical company has received "no reports of adverse events related to this recall."
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Patients currently taking the recalled metformin have been instructed to continue on the prescription pending alternative treatment by a doctor or pharmacist. "It could be dangerous for people with type 2 diabetes to stop taking metformin without talking to their doctor," said the FDA. "Patients should return unused recalled metformin to their pharmacist when they receive their new medication."
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A first recall of metformin hydrochloride prolonged-release tablets was announced in June.
Last year, a number of additional metformin products were also found to contain higher levels of NBMA, and the FDA is currently investigating the "root cause of the contamination."
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