Initially, two pharmaceutical companiesAmneal Pharmaceuticals and Apotexwere involved in the recall.
The FDA then requested other drug manufacturers evaluate their products and test for NDMA.
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What Is Metformin?
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Metformin is a prescription medication used first-line to treat jot down 2 diabetes.
It is prescribed frequently, with over 60 million prescriptions since 2012 in the United States.
The goal of treatingdiabetesis to decrease the amount of glucose, or sugar, in the blood.
Metformin works in a variety of ways to decrease glucose.
One way it works is by allowing muscle cells to use more glucose.
The increased use of glucose by the muscles lowers the glucose level in the blood.
Metformin can also be used off-label to treatpolycystic ovarian syndromeor as an aid to weight loss.
Metformin is generally well tolerated; the most common side effects include:
What Is NDMA?
N-nitrosodimethylamine (NDMA) is a chemical that is formed naturally and is a byproduct of some manufacturing processes.
NDMA can also form during the drug manufacturing process or may form when medications are stored.
These liver diseases then led to the development of liver cancer.
There are no specific studies of the carcinogenic effect of NDMA directly on humans.
Only extended-release products were found to have unacceptable levels of NDMA, and no immediate-release formulations were recalled.
How Does NDMA Form?
This suggests that NDMA may develop at some point in the manufacturing process.
Also, not all manufacturers were affected, which means metformin can be manufactured without the presence of NDMA.
Unlike other medicationslike ranitidine or valsartan, which have available alternativesthere is no substitute for metformin.
Recalled metformin medication should be taken to a pharmacy for proper disposal.
A Word From Verywell
Overall, the risk of developing cancer from NDMA exposure is very low.
Dont stop taking metformin until youve discussed it with your physician or another member of your healthcare team.
U.S. Food and Drug Administration.FDA updates and press announcements on NDMA in Metformin.
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