GovWire

Press release: Metformin diabetes medicines MHRA Update

Medicines Healthcare Products Regulatory Agency

December 6
20:23 2019

The Medicines and Healthcare products Regulatory Agency (MHRA) is aware that outside the UK very low amounts of an impurity, N-nitrosodimethylamine (NDMA), have been found in some metformin diabetes medicines.

Patients in the UK are advised to continue taking their metformin medicines as usual. 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 UK.

As these metformin medicines are also available in Europe and outside the EU, the MHRA is working closely with the European Medicines Agency (EMA) and other regulatory authorities to determine whether any further action is required and will continue to keep patients updated as more information becomes available.

The levels of NDMA seen in the affected non-UK metformin medicines are very low and appear to be within or even below the range that people would normally be exposed from other sources, including food and water.For more information, read the EMAs update on detection of impurities in metformin diabetes medicines and the ongoing investigation by EU regulators here. If patients ha

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