Clinical use of hydroxyethyl starch and serious adverse effects: Need for awareness amongst the medical fraternity

摘要

Hydroxyethyl starch (HES) was developed between 1944 and 1962. Since then, HES has been used to treat or even prevent hypovolemia in thousands of patients. Contrary to the existing scenario, drugs or fluids developed before the eighties were simply registered without mandatory clinical trials. The legislation was changed only in the wake of the thalidomide tragedy, leading to the regulatory requirement of phase 1—3 clinical trials to demonstrate efficacy and safety prior to the approval of new drugs. HES, however, was never properly evaluated for the long term mortality and morbidity before it became available in the market.