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UK metformin patients should continue with therapy

NDMA risk is insufficient to trigger medicines review

December 11th 2019

Tagged: Clinical guidance news MHRA alert

By MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) has reiterated EMA advice that patients using metformin should continue to take their medicines, despite ongoing investigation into possible contamination of non-UK product with N-nitrosodimethylamine (NDMA).

NDMA is classified as a probable human carcinogen on the basis of animal studies. It is present in some foods and in water supplies, but it is not expected to cause harm when ingested in very low levels. 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.

The MHRA states that 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.

If patients have any questions, they should speak to their healthcare professional.

 

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