News Category: Regulatory news
The HPRA has recently been made aware that trace amounts of an impurity, N-nitrosodimethylamine (NDMA), have been found in a small number of metformin diabetes medicines outside of Ireland and the EU. At this time, the HPRA is not aware of any metformin products in Ireland that are affected. The HPRA is working closely with the European Medicines Agency (EMA) and other regulatory authorities in the review of this issue.
The levels of NDMA seen in the affected metformin medicines outside of the EU are very low and appear to be within or even below the range that people would normally be exposed to from other sources, including food and water.
Metformin is widely used alone or in combination with other medicines to treat type 2 diabetes.
Patients are advised to continue taking their metformin medicines as usual. If they have any questions, they should speak to their healthcare professional. The risks from not having adequate diabetes treatment far outweigh any possible effects of the low levels of NDMA seen in metformin medicines outside the EU.
Healthcare professionals should continue to prescribe metformin medicines as normal and remind patients of the importance of keeping their diabetes under control.
Further information on this issue and the ongoing investigation by EU regulators, is available from the EMA website.