Table 2.

Contraindications for hydroxyethyl starch products before and after 2013 in the European Union (EMA) and United States (FDA).

EMA	FDA
Contraindications before 2013 Renal failure (with oliguria or anuria) Patients on dialysis Hypersensitivity Congestive heart failure Hyperhydration states (including pulmonary edema) Intracranial bleeding Severely impaired hepatic function Hyperkalemia Severe hypernatremia or hyperchloremia Clinical conditions with volume overload	Contraindications before 2013 Renal failure (with oliguria or anuria) Hypersensitivity Congestive heart failure Treatment of lactic acidosis Patients on dialysis Clinical conditions with volume overload
Additional contraindications in 2013 Critically ill patients Sepsis Burn injuries Renal impairment Renal replacement therapy Severe coagulopathy and bleeding Organ transplant patients	Additional contraindications in 2013 Critically ill adult patients Sepsis Renal dysfunction Severe liver disease Pre-existing coagulation/bleeding disorders Patients undergoing open heart surgery in association with cardiopulmonary bypass
Additional contraindications in 2018 Fluid maintenance therapy Dehydrated patients Cerebral hemorrhage	No update

EMA, European Medicines Agency; FDA, United States Food and Drug Administration.