The European Medicines Agency (EMA) and the competent medicine authorities of the European member states, including the FAMHP, have been notified that in a small number of diabetes medicines based on metformin outside of the European Union, a nitrosamine contamination (NDMA, N-nitrosodimethylamine) has been detected. Currently, analyses are being performed on the medicines within the European Union.
Very small amounts of nitrosamine impurities have been found in the medicines with metformin from outside of the European Union. These are quantities smaller than those present in other sources to which people could be exposed, such as certain foodstuffs and water.
Currently there are data that indicate that medicines with metformin from within the European Union are also affected. The EMA and the competent medicine authorities from the European member states work together with companies to test the medicines from within the European Union.
Recommendations for patients
You can continue to use your diabetes medicines with metformin. The possible effects of the low amounts of nitrosamine contamination that have been shown in the tests do not outweigh the risk of not adequately treating your diabetes.
Health care providers must remind patients of the importance of keeping their diabetes under control.
Metformin is used on a large scale alone or in combination with other medicines to treat type 2 diabetes. In most cases this is a first line treatment and it works by lowering the glucose production in the body and the absorption of it from the intestine.
NDMA is classified as possibly carcinogenic for humans (a substance that could cause cancer) based on animal testing. It is present in some foodstuffs and in water sources, but is not expected to cause damage when ingested in very small quantities. Where nitrosamines are found in drugs, the risk of developing cancer is low.
In 2019, NDMA and other nitrosamine impurities were found in some blood-pressure reducing medicines: sartanen and in medicines with ranitidine. EMA started a review of the medicines with ranitidine and has launched a procedure that asks marketing authorisation holders of medicines to take specific measures to avoid the presence of nitrosamine contaminations in medicine for human use.
News report from the EMA