23.11.2018
The Swissmedic laboratory has tested the valsartan preparations recalled in July 2018 as a precautionary measure for contamination with the nitrosamine NDMA (N-nitrosodimethylamine). The concentration of impurities was found to be above the level considered safe. Thus the batch recalls were justified.
In July 2018, several manufacturers of medicinal products had been required to recall valsartan-containing products owing to contamination with the nitrosamine NDMA, which is considered to be carcinogenic. As part of worldwide investigations into the nitrosamine issue, a number of independent Official Medicines Control Laboratories (OMCL) have been examining finished medicinal products and active substances containing valsartan and other sartans for contamination with NDMA and the related substance NDEA (N-nitrosodiethylamine).
Swissmedic’s own laboratory (OMCL) initially tested all sartan-containing medicinal products currently on the Swiss market for possible contamination with nitrosamines and provided ongoing information on its findings.
NDMA contamination of recalled valsartan products now proven
As a result – and as announced at the end of August 2018 – the OMCL has now also examined the batches of antihypertensive medicines containing the active substance valsartan that were recalled in July for contamination with NDMA.
These tests have shown that concentrations exceeded safe levels in all samples examined and that the recalls were therefore justified. The average NDMA concentrations in the recalled products were similarly high to those in the valsartan-containing agents recalled in the EU (approx. 60 parts per million).
Tests continuing
As a precaution, Swissmedic is continuing to examine both finished medicinal products and active substances containing sartans that are currently authorised and available on the Swiss market for contamination with NDMA and NDEA.