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In the September edition of Prescrire International: sartan medicines contaminated by impurities which are probable carcinogens

FREE DOWNLOAD The exposure of patients all around the world and over a period of several years to impurities which are known to be carcinogenic, and which were present in commonly used medicines, shows that the systems intended to guarantee pharmaceutical quality need to be improved.
Full text available for free download.

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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