NDMA Impurities in Metformin Products
FDA publishes a recalled metformin list including details about metformin products that have been recalled. Patients taking recalled ER metformin 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. FDA recommends that health care professionals continue to prescribe metformin when clinically appropriate; FDA testing has not shown NDMA in immediate release (IR) metformin products (the most commonly prescribed type of metformin).
Important information about the NDMA impurity in metformin products
- The U.S. Food and Drug Administration has recommended recalls of certain metformin products that may the impurity N-nitrosodimethylamine (NDMA) above the acceptable intake limit.
- Patients taking recalled metformin 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.
- The agency is also asking all manufacturers of extended release versions of metformin to evaluate their risk of excessive NDMA and to test at-risk product before each batch is released onto the U.S. market. If testing shows NDMA above the acceptable intake limit, the manufacturer must inform the agency and should not release the batch to the U.S. market.
- FDA’s testing has shown elevated levels of NDMA in some extended release (ER) metformin formulation but not in the immediate release (IR) formulation or in the active pharmaceutical ingredient.
How long has the NDMA been in metformin?
FDA does not have scientific evidence to determine how long NDMA has been present in metformin products and we are investigating the root cause of its presence.
What is the cancer risk to someone who has been taking affected metformin?
We do not know how long patients may have been exposed to higher NDMA levels in ER metformin. FDA does not expect nitrosamines to cause harm when ingested at or below the acceptable intake limit levels (such low levels of nitrosamines are present in foods in low levels and ingested as part of usual diets) even over a long period of time (such as a 70-year lifespan). Nitrosamine impurities may increase the risk of cancer if people are exposed to them at above acceptable levels over long periods of time, but we do not anticipate that shorter term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer. We are working to ensure medicines on the U.S. market do not exceed the acceptable intake limit.
How do I know if my metformin has been recalled?
Please see the FDA’s Drug Recalls page for information about any recalled metformin products.
What should I do with my recalled metformin?
Patients taking recalled metformin 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. Patients should return unused recalled metformin to their pharmacist when they get their new medication.
Will these recalls cause a shortage of ER metformin?
FDA has recommended five manufacturers of metformin ER recall lots of their metformin ER tablets. There are additional manufacturers of the metformin ER formulation that supply the bulk of the US market, and their products are not being recalled. The agency will work closely with manufacturers to prevent or reduce any potential impact of shortages.
Does the agency believe manufacturers can make ER metformin without NDMA, or is it like ranitidine and will always be there?
Because the agency has tested samples of ER metformin and found no NDMA in many samples, we believe it is possible to manufacture metformin without the NDMA impurity. FDA reminds manufacturers that it is their responsibility to develop and use suitable methods to detect impurities, including when they make changes to their manufacturing processes. If a manufacturer detects new or higher levels of impurities, they should fully evaluate the impurities and take action to ensure the product is safe for patients.
What is the source of NDMA in metformin?
This is an ongoing investigation. The agency has determined the NDMA does not come from the active pharmaceutical ingredient in metformin but is investigating the root cause of the impurity.
Are both immediate release and extended release metformin affected?
No. The agency has only detected levels of NDMA above the acceptable intake limit in some extended release metformin but not in any tested immediate release metformin.
Will the FDA post the testing method it used?
Yes. The agency has posted its testing method on the public website for use by industry, third party laboratories and our international regulatory partners. Manufacturers may use their own testing method or use the FDA’s posted method, but any testing method should be validated by the user if the resulting data are used to support a required quality assessment of the active pharmaceutical ingredient or drug product, or if the results are used in a regulatory submission.
- FDA article NDMA impurities in metformin products
- Liquid Chromatography-High Resolution Mass Spectrometry (LC-HRMS) Method for the Determination of NDMA in Metformin Drug Substance and Drug Product
- List of recalled metformin products
- Information about Nitrosamine Impurities in Medications
- FDA Recalls of Extended Release (ER) Metformin Several Companies
- FDA approved a new vaginal gel for the prevention of pregnancy in women
- 50 Interesting Medicine Information Every Pharmacist Need to Know
- List of Banned Medicines in Nepal for Production,Sale- Distribution and Import
Pharma Info Nepal (Nabin’s Blog) is Popular Pharmacy information sharing online platform initiated by Nabin Bist since 2019. Thousands of Pharmacy professionals have trusted Pharma Info Nepal as a right blog to find the latest Pharma opportunities, information & resources for pharmacy updates in Nepal . If you have any complaints, information, or suggestions about the content published on Pharma Info Nepal/If you also like to write an article, please feel free to contact at email@example.com. Thanks for visiting us.
Nepal’s Leading Pharma Portal | Complete Pharma Updates