The U.S. Food and Drug Administration recently announced that certain types of Metformin have exceeded agency safety standards for the chemical N-Nitrosodimethylamine (NDMA). Metformin is a common prescription drug used to control high blood sugar levels in people with type 2 diabetes and prediabetes. The type of Metformin identified is the extended-release (ER) formulation.
As a result, the FDA has recommended that five manufacturers of Metformin (ER) voluntarily recall their products in the U.S.
There are additional manufacturers that supply a significant amount of Metformin ER in the U.S., and their products are not being recalled at this time. However, the FDA is asking all manufactures of this drug to test each batch. If NDMA is above the acceptable intake limit, the manufacturer should inform the FDA and not release the batch to the U.S. market.
What exactly is NDMA?
NDMA is a type of nitrosamine and is a common contaminant found in water and foods including cured and grilled meats, vegetables and dairy products. In fact, everyone is exposed to some level of NDMA in the food supply. According to the FDA and the international scientific community, NDMA should not cause harm when ingested at low levels, even over a whole lifespan. Nitrosamine impurities may increase the risk of cancer if people ingest them at above-acceptable levels over long periods of time, but not with shorter term exposure.
The FDA has also been working to identify other medicines with nitrosamines above the acceptable intake limit. Improved technology and testing methods allow for better detection of this substance, and a better understanding of the specific manufacturing steps that may increase the risk of nitrosamines being present in the drug.
What should you do if you take Metformin ER?
Patients should continue taking Metformin, even after recalls occur, until they consult with their health care provider who can prescribe a replacement. That’s because patients could have dangerously low levels of blood sugar if they stop taking the drug. So far, FDA testing has not shown NDMA in Metformin that is an immediate release (IR) formulation.
To see the company recall notices that the FDA have recommended visit www.fda.gov/safety/recalls-market-withdrawals-safety-alerts and search “metformin.” To date, two brands of Metformin ER have been identified: Amneal and Apotex Corp.