Recall of medicines diabetes due to carcinogenic substance

The Health and Youth Care Inspectorate is recalling batches of diabetes medicines because they contain carcinogenic substances. The inspection confirms this Wednesday morning after questions from NRC and research program Zembla.

These are diabetes medications from three manufacturers – Centrafarm, Consilient Health and TEVA – that contain the active ingredient metformin. The pills are used in the treatment of type 2 diabetes. In the Netherlands 655,000 patients take metformin.

Pharmacists will ask their patients to return the contaminated medicines to the pharmacy.

Research by the manufacturers, commissioned by the European Medicines Agency (EMA), has shown that the pills have a too high concentration N-nitrosodimethylamine, abbreviated NDMA. Animal studies have shown that NDMA is carcinogenic.

According to the inspectorate, there is “no acute risk” to patients who have used the contaminated metformin and a replacement drug is available.

One of the diabetes drugs that patients will have to hand in in the coming days is Glucient SR 500 mg from Consilient Health. Singapore took batches of Glucient from the market a year ago because of too high concentrations of NDMA.

Third drug pollution

It is the third major drug contamination with NDMA in two years. At least five million pills have been recalled in the Netherlands so far. In the summer of 2018, 180,000 patients with heart disease and high blood pressure were found to be taking contaminated valsartan. Ultimately, 3.6 million boxes of valsartan had to be returned to the pharmacy to be destroyed. The blood pressure lowering drug losartan, also contaminated with NDMA, involved 321,000 packages.

Read more about the recovery of contaminated medicines: Hundreds of thousands of people were given contaminated pills. How could that be?

In 2019, hundreds of thousands of users of the antacid ranitidine had to stop taking their pills. More than one million packages have been retrieved. Almost all ranitidine contained NDMA.

At the end of 2019, it turned out that metformin could also be contaminated with NDMA. While metformin was recalled in a number of countries, this did not happen in the Netherlands. In Europe, pharmaceutical companies were given the opportunity to test their metformin for nitrosamines themselves before November 15 this year. The test results are now triggering this recall.

Laboratory research

Dutch regulators have also been investigating the contamination of Mylan brand metformin since last month. The investigation had to determine whether a recall is necessary. The reason is the result of American laboratory research commissioned by NRC in Zembla. It turned out that four batches of Mylan pills contained too high a concentration of NDMA.

According to Mylan, there was nothing wrong. Own test results would not have shown increased concentrations. One of the batches that Mylan examined was also tested by NRC in Zembla. According to Mylan, the NDMA value was below the allowable limit, according to the study it was above it.

The inspection says in a response that it sees no reason for an independent investigation into the contamination of the pills from Mylan.

Also read the article about Mylan

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