Dutch regulators are investigating whether pills of the diabetes drug metformin of the Mylan brand contain too much NDMA, a carcinogenic substance. Zembla reports that. The research program, together with NRC, commissioned American laboratory research into pills.
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The media had fifty tablets of 500, 850 and 1000 milligrams of metformin from five brands analyzed for the presence of NDMA. Animal studies have shown this substance to be carcinogenic, which is why there is a strict international limit for NDMA.
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Safety limit
Half of the tablets studied do not contain traceable NDMA. In the other half the amount differs, but in most cases the concentrations remain below the safety limit. Only the pills from Mylan stand out negatively, says Zembla. According to Mylan, who also tested, NDMA values remained below the allowable limit.
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The Healthcare and Youth Inspectorate (IGJ) and the Medicines Evaluation Board (MEB) say in a statement to Zembla that the investigation by the regulators will have to determine whether a recall is necessary.
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In the Netherlands 655,000 patients use metformin. Mylan provides a quarter of all metformin used in the treatment of type II diabetes.
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No steps
The IGJ and the MEB tell Zembla that they cannot take any steps yet, although the findings raise questions. A recall could also lead to a metformin deficiency, they say. For now, patients are advised to continue taking their Mylan metformin.
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“We understand that the results of the Zembla / NRC study may cause unrest. The violations that we see in this are annoying and undesirable, but it is not a very big risk “, according to IGJ and MEB.
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