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‘Inspection was not open about contaminated pills’

Over the past two years, patients have been incompletely informed by the Healthcare and Youth Care Inspectorate (IGJ) about carcinogenic substances in three commonly used medicines, according to research by NRC in Zembla.

The drugs turned out to be contaminated with, among other things, N-nitrosodimethylamine (NDMA). Animal studies have shown that NDMA is carcinogenic. Hundreds of thousands of patients with heart disease, high blood pressure or stomach acid problems had to return at least five million pills and drinks contaminated with NDMA to their pharmacies. In 2018 and 2019 it concerned the antihypertensive valsartan and the gastric acid inhibitor ranitidine.

“Two types of pills of the diabetes drug metformin appear to be contaminated with NDMA. These drugs have not (yet) been recalled,” NRC writes. “The RIVM investigated metformin pills from twelve batches. In two of them, the contamination appeared to be higher than the safety limit.” The IGJ tells the newspaper that the investigation was not intended for publication, “but to get a rough picture of the situation in the Netherlands”.

Big overrun

Valsartan did not test for a large batch of recalled pills to determine the degree of contamination. “The first signs were that it was a major exceedance and that is why we immediately focused on recalling these drugs as soon as possible,” the IGJ told NRC.

Emeritus professor of toxicology Martin van den Berg of the University of Utrecht tells the newspaper that he finds this incomprehensible. “As a result, a retrospective risk analysis is no longer possible for patients who have often taken the drug for years.”

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