A diabetes drug used by many has been recalled because it was found to contain high levels of a cancer-causing contaminant. Metformin hydrochloride extended-release tablets, manufactured by Indian pharmaceutical company Marksans Pharma Limited, were found to have exceedingly high levels of “probable human carcinogen” NDMA, according to the Food and Drug Administration (FDA) recall.
The metformin tablets are used to lower glucose levels in people with type 2 diabetes, but they were found to have over the acceptable daily limit of 96 nanograms of NDMA. The company did not state how many nanograms of NDMA were in the metformin tablets.
The recall is an expansion of an earlier recall in June of this year and includes “an additional 76 unexpired lots,” the FDA recall states. The recall is for the metformin tablets between 500 mg and 700 mg distributed by Time-Cap Labs, Inc. across the U.S.
The Recalled Drugs Can Be Identified by the National Drug Code Numbers, but the FDA Warned Patients to Speak to Their Doctor Before Changing Their Medication
According to the FDA, the drugs in question are the Metformin Hydrochloride Extended-Release Tablets, USP 500mg and USP 750mg, identified below with their National Drug Code numbers. The tablets are “white to off white, capsule shaped, biconvex tablets, debossed with ‘101’ on one side and plain on the other side” or with “‘102’ on one side and plain on the other side.”
Metformin Hydrochloride Extended-Release Tablets, USP 500mg:
90 counts: 49483-623-09
100 counts: 49483-623-01
500 counts: 49483-623-50
1000 counts: 49483-623-10
Metformin Hydrochloride Extended-Release Tablets, USP 750mg:
100 counts: 49483-624-01
The FDA recall indicates that Type 2 diabetes patients who are currently taking this drug should consult their doctor before they stop taking it, as it could be more dangerous to stop taking metformin:
Consumers taking these recalled product lots of Metformin ER Tablets should continue taking it until a doctor or pharmacist gives them a replacement or a different 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. Consumer should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Many Other Metformin Products Were Recently Found to Have High Levels of NDMA & the FDA Is Investigating
Many metformin products were recalled in the past year for their levels of NDMA and the FDA isn’t sure why that carcinogen finds itself in metformin tablets, CNN reported. According to the outlet, many medications with NDMA usually have only low levels of the carcinogen and stay within the acceptable daily intake limits, however.
The FDA is exploring the connection and has asked all manufactures of extended-release metformin tablets to test all of those products for NDMA levels before releasing those drugs to the U.S. market. According to the FDA’s website, high levels of NDMA has been found in “some extended release (ER) metformin formulation but not in the immediate release (IR) formulation or in the active pharmaceutical ingredient.”
The agency also indicated that they are actively investigating the source of NDMA in metformin and they do not believe that the metformin active pharmaceutical ingredient is the main source of NDMA at this time.
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