Summary
- Since mid-2018, nitrosamines, which are "probable carcinogens", have been found worldwide as impurities in drugs containing valsartan, losartan or irbesartan. Their presence has resulted in the recall of many batches.
- In the European Union, while awaiting improved production safety, five sartan medicines containing a tetrazole ring (candesartan, irbesartan, losartan, olmesartan and valsartan) will be marketed until 2021 with potentially detectable levels of impurities. It would seem advisable to avoid them.
- This alert shows that the system which is intended to guarantee the pharmaceutical quality of drugs has weaknesses and needs to be improved.
Full text available for free download.
©Prescrire 1 September 2019
"Sartan medicines: contamination by impurities which are probable carcinogens" Prescrire Int 2019; 28 (207): 220-221. (Pdf, free).
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