A POPULAR drug prescribed to diabetes patients has been recalled over fears it contains large levels of a cancer-causing ingredient.
Metmorfin hydrochloride was this week announced to contain an unusually high level of N-Nitrosodimethylamine (NDMA), considered to be a human carcinogen, by the Food and Drug Administration (FDA).
Marksans Pharma Limited, the manufacturer of Metmorfin, have expanded a recall initially announced in June that now includes an additional 76 unexpired lots of the medication.
The recalled drugs are marketed as “extended-release tablets” under the brand name Time-Cap Labs, Inc.
The drug helps lower the blood glucose levels of those with type 2 diabetes, while the recall applies to metformin tablets between 500 mg and 750 mg.
According to CNN, the FDA is still investigating where NDMA comes from and how it ends up in metformin products.
Most levels found in medications are generally low and fall within the FDA's accepted daily intake,
A statement from the DFA read: “Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96ng/day.
“Therefore, out of an abundance of caution, an additional 76 lots are being recalled.”
The 500 mg tablets are embellished with “101” on one side while the 750 mg tablets are debossed with “102” on one side, the agency said.
The FDA advises users to continue taking the recalled tablets until a medical professional provides a replacement or alternative treatment option.
“It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional,” the FDA continued.
Consumers “should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.”
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