Public Citizen Seeks Ban on HES Intravenous Solutions

Public Citizen is questioning FDA’s delay in banning from the market all hydroxyethyl starch (HES) intravenous (IV) solutions, a move the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommended 1/12. Last year, the group petitioned the agency to remove HES IV solutions from the market, and a decision has not been made on the pettion.

In 2013, the EMA’s PRAC recommended a ban on HES solutions in response to evidence showing risks with the products’ use. It soon reversed its position shortly thereafter and recommended to keep the solutions on the market for use in certain patients. Now, in response to two studies confirming that the EMA’s restrictions on HES use of HES were not being adhered to, “the PRAC finally has brought its recommendations in line with the scientific evidence,” Public Citizen says. “The U.S. Food and Drug Administration (FDA) must now follow suit with an immediate ban on HES solutions in the U.S.”