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Comments to the EMA’s Pharmacovigilance Risk Assessment Committee Regarding the Safety of Hydroxyethyl Starch Solutions

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Public Citizen calls on the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) to follow the example of Sweden’s Medical Products Agency and require the immediate removal of hydroxyethyl starch (HES) solutions from the market in Europe because the solutions cause kidney failure, bleeding, and death and there are safer alternatives available. Recent drug utilization studies in 10 European Union countries indicate the futility of the PRAC’s 2013 decision to restrict the use of HES products in Europe.

See Public Citizen’s other work on HES solutions.