Urine derived clot busters do not pose Zika risk says EMA
The European Medicines Agency (EMA) shared details of its findings this week, explaining that processing and viral inactivation techniques used to produce urine and plasma derived medicines are effective at removing viruses, including Zika.
Urokinases are used to break up blood clots. They are made either from enzymes extracted from human urine or in genetically engineered cell lines in culture.
According to the EMA, the Zika virus outbreak in South America last year prompted regulators to question the safety of extracted urokinases on the basis that many are made from urine sourced outside the European Union (EU).
The EMA’s Committee for Medicinal Products for Human Use (CHMP) – which reviewed urokinase safety – concluded that “manufacturing processes for these products contain complementary steps with inactivation/removal capacity for enveloped viruses.”
The Committee also concluded plasma-derived medicines – such as coagulation factors – are also safe, explaining that manufacturing processes like pasteurisation, filtration and solvent based inactivation are sufficient to remove Zika virus.
