Metformin Hydrochloride Recall; Potential Carcinogen Found in Drug
The U.S. Food and Drug Administration (FDA) has announced the recall of a widely-used prescription drug used to treat diabetes as an ingredient may cause cancer.
Metformin hydrochloride extended-release tablets were recalled by the manufacturer based in India, Marksans Pharma Limited, after discovering that the drug contains higher than allowable levels of NDMA, a “probable human carcinogen.”
The drug is used to treat type 2 diabetes and has been effective in lowering glucose levels.
The recall applies to metformin tablets between 500 mg and 750 mg, sold under the brand name Time-Cap Labs, Inc.
According to an FDA Bulletin, “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant found in water and foods, including meats, dairy products, and vegetables. Marksans Pharma Limited has not received any reports of adverse events that have been related to this recall.”
This substance has also been found in other prescription drugs, and at unsafe levels. Valsartan was recalled in 2018 for the same reason.
Notification letters are being sent to the distributors and customers of Marksans Pharma and a press release is also in the works. The manufacturer is also arranging for the return/replacement of recalled product lots.
Patients taking metformin hydrochloride for type 2 diabetes or to lower blood sugar levels are advised to contact their health care provider for instructions on what to do or for replacement of their prescriptions.
The FDA bulletin provides a complete breakdown of the lots covered in the recall. Access the bulletin here.
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