FDA: No HES Solutions for Critically Ill
The FDA is recommending that hydroxyethyl starch (HES) solutions should not be used in critically ill adult patients, including those with sepsis and those admitted to the ICU.
In addition, the FDA stated that a Boxed Warning to include the risk of mortality and severe renal injury is needed, as well as a warning about excessive bleeding in the Warnings and Precautions section of the package insert.
HES solutions are used for the treatment of hypovolemia when plasma volume resuscitation is desired.
These safety updates are a result of recent data analysis that indicated an increased risk of mortality and renal injury requiring renal replacement therapy in the critically ill; and excess bleeding particularly in patients undergoing open heart surgery in association with cardiopulmonary bypass.
The FDA is recommending the following:
- Do not use HES solutions in critically ill adults, including those with sepsis and those admitted to the ICU
- Avoid use in patients with preexisting renal dysfunction and in patients undergoing open heart surgery in association with cardiopulmonary bypass
- Discontinue HES at the first sign of renal injury or coagulopathy
- Continue to monitor renal function for >90 days in all patients
For more information call (800) 332-1088 or visit the FDA website.