BETHESDA, MD 25 June 2013—A June 24 safety communication from FDA warns clinicians against using hydroxyethyl starch solutions in seriously ill adults.
According to FDA, the agency's analysis of data on hydroxyethyl starch solutions found that they increase the risk of death and kidney failure in critically ill adults, including those who have sepsis or are admitted to an intensive care unit, and should not be used in these patients.
This information will be conveyed in a classwide boxed warning in the labeling of all hydroxyethyl starch solutions, the agency stated. And the "Warnings and Precautions" section of the labeling will bestate that the products should not be used in patients undergoing open-heart surgery in conjunction with coronary artery bypass procedures because excessive bleeding may occur.
FDA also stated that hydroxyethyl starches should not be administered to patients with preexisting kidney dysfunction. The products should be discontinued at the first sign of kidney injury or coagulopathy.
Because kidney injury can occur up to 90 days after the discontinuation of hydroxyethyl starch therapy, all patients should be followed for at least that time after treatment with the products.
These changes are related to information presented during a public workshop that FDA convened last September to assess the benefits of hydroxyethyl starches for fluid replacement and their effects on homeostasis and kidney function.
The workshop participants, in general, were not supportive of the use of hydroxyethyl starches for fluid replacement in patients with trauma.