The National Institute for Public Health and the Environment (RIVM) has found quantities of the harmful substance NDMA in a random sample of three variants of the diabetes drug metformin that are ‘close to the permitted limit’. Due to the margin of uncertainty, it is unknown whether the substance, which is likely to be carcinogenic, is just above or just below the maximum permitted dose in the drugs.
The Healthcare and Youth Inspectorate (IGJ) sees ‘no acute danger to safety’ and advises patients to continue to use their medication. A major European investigation that has been running for some time should provide more clarity about the drugs next month.
‘Keep taking metformin, there is no additional safety risk’
The Dutch College of General Practitioners (NHG) also advises its own constituents to continue prescribing and patients to use metformin. “With the information available now, there does not seem to be an additional security risk.”
At the same time, the NHG is ‘concerned about the lack of clarity about the safety of medication’. “This creates uncertainty for both GPs and patients and does not contribute to the safe use of medication by patients,” says the association.
Inspection had sample results as early as May
The reason for the report that the IGJ released on Thursday is reports by NRC and Zembla about contaminated medicines. The inspectorate already received the results of the RIVM sample in May, but did not make them known at the time because it was only intended to obtain a ‘first picture’ and was too small to be representative.
In nine of the products studied with metformin, the amount remained below the legal limit. It has been set so low that the risk is negligible. ‘When 100,000 patients use the maximum dose of a drug throughout their lives, which includes the maximum permissible limit of the impurity every day, then of these 100,000 people, 1 extra person will have a cancer at some point in their life. ‘, explains the IGJ.
No recall action
Metformin is mainly used by people with type 2 diabetes, the variant that often develops in middle age. The drug lowers blood sugar, which can prevent health damage.
This means that the benefits ‘outweigh the theoretical risk of a slight exceeding of the NDMA limit’, according to the inspectorate. There will therefore be no recall.
The NHG calls on people who use metformin via the medical website Thuisarts.nl not to stop. The drug is effective, safe and there are no comparable alternatives, according to the GP organization.
Source: ANP
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