MHRA considering ‘further action’ after metformin diabetes drugs recalled in Singapore over impurities

Several metformin-containing medicines have been recalled in Singapore after reports of contamination with a probable human carcinogen, leading to testing of products in the EU.

Metformin pills

The Medicines and Healthcare products Regulatory Agency (MHRA) is considering whether to take “further action” after metformin products were recalled in Singapore over reports of contamination.

Some 3 out of 46 metformin diabetes medicines have been recalled by Singapore’s Health Sciences Authority because they contained “trace amounts” of N-nitrosodimethylamine (NDMA), which it said “are above the internationally acceptable level”.

NDMA is classified as a probable human carcinogen, but is not thought to cause harm when ingested at very low levels.

However, the MHRA said in a statement, published on 6 December 2019, that because ”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”.

The UK regulator advised patients to continue taking metformin as ”risks from not having adequate diabetes treatment far outweigh any possible effects of the low levels of NDMA” found in the medines.

It added that the levels of NDMA found in the recalled batches ”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 EMA said in a statement, published on the same day, that it has seen “no data indicating that EU metformin medicines are affected”.

But added: “Authorities in the EU are in the process of working with companies to test EU medicines and will provide further updates as more information becomes available.”

In September 2019, the EMA announced that it would start a review of ranitidine medicines after tests revealed that some products contained the impurity.

Then, in October 2019, the MHRA recalled some ranitidine products as a precautionary measure over the contamination.

In 2018, NDMA was also found in several blood pressure medicines, known as ‘sartans’, leading to recalls and an EMA review.

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Citation
The Pharmaceutical Journal, PJ, January 2020, Vol 304, No 7933;304(7933):DOI:10.1211/PJ.2019.20207448