The FDA has ordered that hydroxyethyl starch solutions used to treat hypovolemia must include a boxed warning about the risk of kidney injury and death. The risk appears to be highest among patients with renal impairment and those undergoing open heart procedures with cardiopulmonary bypass. The FDA's decision follows a recommendation of the European Medicines Agency's Pharmacovigilance Risk Assessment Committee to suspend marketing approval. The FDA said the products could remain on the U.S. market provided that patients and clinicians are aware of the risks.
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