Metformin is a common diabetes drug in both Europe and the U.S. It’s taken by approximately 3 million people in the UK and millions more across the Atlantic. However, it’s currently under investigation by health authorities in the U.S., Canada, UK, and the EU after two suppliers from Singapore recalled the drug due to unsafe levels of a chemical called NDMA, which is a carcinogen.
This has lead to other national agencies such as the British Medicines and Healthcare products Regulatory Agency (MHRA) (1) and the US Food and Drug Administration (FDA) starting their own investigations not only on metformin but on other drugs such as Glucophage.
NDMA is a byproduct of chlorine and certain pesticides and has been deemed as “probably carcinogenic to humans”. Metformin isn’t the first drug to be recalled for this reason, either. Various heartburn and indigestion drugs such as Zantac have been recalled previously in the UK and the U.S. for the same reason. (2)
Despite this, diabetes patients are still urged to continue taking their drugs as they are essential for their well-being and the risk or lack thereof hasn’t been confirmed yet. Only 3 out of the 46 versions of metformin in Singapore were pulled from the market because of unsafe amounts of NDMA.
The MHRA was quick to issue a statement and calm people in the UK:
‘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.’
‘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.’
If more versions of metformin need to be recalled this will cause a huge stir in the market for diabetes drugs. Metformin, in all its forms, has been sold around 22.2 million times just in the UK in 2018 for a total cost of over £108.5 million.
A recent study showed that in 2013 around 84% of UK type 2 diabetes patients were prescribed metformin (3) – that’s almost 3 million people. The drug is also used to treat polycystic ovary syndrome but that’s not its intended purpose. The most common brand names of metformin in the UK include Bolamyn, Diagemet, Glucient, Glucophage, and Metabet. In the U.S. the brands to keep in mind include Fortamet, Glucophage, Glucophage XR, Glumetza, and Riomet.
However, there’s still no confirmation if any of these brands’ supplies have been contaminated. There are alternatives to these brands as well but they tend to be more expensive and have additional side effects.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (4), also issued a statement:
‘The FDA is investigating whether metformin in the U.S. market contains NDMA and whether it is above the acceptable daily intake limit of 96 nanograms. The agency will recommend recalls as appropriate if high levels of NDMA are found,’
As investigations continue across the developed world, American and European health organizations are banning doctors from prescribing the contaminated drugs and are recalling every product that’s found to be contaminated. They are also recommending both professionals and patients to steer toward alternative drugs that don’t contain metformin as well as to follow the situation’s development closely.