Patients who take plasma or urine derived medicines have no risk of contamination from the Zika virus, according to assessments carried out by European Medicines Agency and authorities in the EU Member States.
Zika
Plasma and urine based medicines can be sources from parts of the world where the Zika virus is prevalent. The medicines are manufactured from human blood and urine, thus EU regulators sought reassurance that there was no risk of the virus contaminating final medical products.
Plasma-derived medicines are used to treat and prevent serious diseases and include coagulation factors and immunoglobulins. Urine-derived products are manufactured from pooled human urine and include certain hormone-based treatments and urokinase products (medicines used to break up blood clots).
At a meeting this month the EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that the manufacturing processes used for plasma-derived products, including pastuerisation and virus filtration remove the Zika virus and that no additional safety measures were needed.
Regading urine-derived products, the CMDh, a medicines regulatory body representing the EU, found that the manufacturing processes for the products contain sufficient steps for the inactivation or removal of enveloped virus, which includes the Zika virus.
The findings from these assessments on the viral safety of plasma-derived and urine-derived medicines are available in a report from the CHMP’s Biologics Working Party(BWP).