Naslov
Presence of nitrosamine impurities in medicinal products

Autori
Sedlo, Ilijana ; Kolonić, Teo ; Tomić, Siniša

Izvornik
Arhiv za higijenu rada i toksikologiju (0004-1254) 72 (2021), 1; 1-5

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, pregledni rad, znanstveni

Ključne riječi
carcinogenicity ; metformin ; NDEA ; NDMA ; ranitidine ; sartans

Sažetak
In 2018, some sartan medicinal products were reported to be contaminated with nitrosamine compounds, which are potent mutagenic carcinogens. Two nitrosamines received particular attention: N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA). These have since been confirmed in different types of medicinal products, including ranitidine and metformin. Consequently, the European Medicines Agency (EMA) started an investigation into the cause of contamination and an assessment of the risk to patients taking contaminated medicinal products. The main source of contamination were changes in production, which involves combinations of amines and nitrogen compounds and the use of specific catalysts and reagents. Withdrawals of medicinal products that took place in Croatia did not lead to a shortage of sartan- or metformin-containing medicines. Moreover, ranitidine had been preventively withdrawn all over the EU, including Croatia, creating shortages at the time, but was subsequently replaced with therapeutic alternatives.

Izvorni jezik
Engleski

Znanstvena područja
Farmacija

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