NRC / Zembla has had 50 pills tested, four of which are above the permitted limit. These are pills from the manufacturer Mylan. The analysis data from NRC / Zembla raise questions. Mylan has informed the MEB that batches they have tested are below the permitted limit. One batch was tested by both Mylan and NRC / Zembla. According to Mylan, that batch is below the limit of NDMA, according to NRC / Zembla above the limit. IGJ and MEB are going to find out where this difference comes from.
Overruns limited but undesirable
The exceedances resulting from the NRC / Zembla study are limited but undesirable: IGJ and MEB assess the additional risk as small. The limit of NDMA in metformin is strict and has been set at a negligible risk: when 100,000 patients use the maximum dose of a drug throughout their lives, which contains the maximum allowable amount of the impurity daily, then of these 100,000 people will possibly 1 extra person will get a form of cancer at some point in his or her life.
The additional risk as a result of the limited exceedance of the four found batches above the limit does not outweigh the benefits of the use. Metformin is a critical drug for the treatment of diabetes. Patients cannot just stop doing this, because otherwise their blood sugars will be disrupted. In the event of a recall, it cannot be ruled out that a metformin deficiency will occur.
Major European research
A major European study is currently underway into metformin pollution. It is essential that the MEB receives complete test results from all market parties. Then there is a complete overview of the Dutch market situation and of the risk of shortages in the event of a recall.
By: Nationale Zorggids
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