The FDA has analyzed recent data that indicate risk of mortality in critically ill patients and renal injury requiring renal replacement associated with the use of HES Solutions. Patients need to be made aware of these risks and discuss them with their healthcare providers. The FDA is recommending the following:

• Do not use HES solutions in critically ill adult patients including those with sepsis and those admitted to the ICU
• Avoid use in patients with pre-existing renal dysfunction
• Discontinue use of HES at the first sign of renal injury
• Need for renal replacement therpay has been reported up to 90 days after HES administration. Continue to monitor renal function for at least 90 days in all patinets.
• Avoid use in patients undergoing open heart surgery in association with cardiopulmonary bypass due to excess bleeding.
• Discontinue use of HES at the first sign of coagulopathy.