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Health regulators investigating low-level risk of contaminant in metformin

Health regulators are investigating whether any EU batches of metformin are affected by a contamination of N-nitrosodimethylamine (NDMA).

The regulatory agencies state that the risk on health is very low and has reassured patients that they can continue to take their medication as usual.

The investigations come after a small number of brands of metformin in Singapore were found to contain NDMA.

NDMA is a possible carcinogen but does not present a significant risk of cancer at very low levels. Three forms of metformin medication were recalled in Singapore after tests found that they contained levels of NDMA that were above the internationally acceptable level.

There are 46 versions of the drug in Singapore and therefore the three types recalled represent a minority of the metformin available.

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) are investigating whether any forms of metformin are affected within Europe or the US respectively.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) states that it 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 MHRA advises patients on metformin to continue taking the medication, stating 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.”

The statement from the MHRA adds: “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.”

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