SILVER SPRING, Md. -- Hydroxyethyl starch solutions used to treat hypovolemia must carry a boxed warning about increased risk of kidney injury and death, the FDA said Monday.
The move comes 2 weeks after an expert advisory committee in the European Union recommended that these products be pulled from the market entirely.
Hydroxyethyl starch is a key component of infusion solutions used to expand blood volume in certain clinical situations, such as septic shock or open heart surgery with cardiopulmonary bypass.
At a public workshop held by the FDA last September, researchers presented data from a variety of studies indicating that mortality and renal impairment were greater in patients receiving hydroxyethyl starch solutions compared with other approaches.
Many of these studies were included in a meta-analysis published earlier this year, which found a relative risk of 1.09 (95% CI 1.02-1.17) for patients receiving hydroxyethyl starch versus other treatments such as Ringer's acetate, after excluding studies by a once-prominent researcher believed to have fabricated some or all of the data.
The FDA determined that hydroxyethyl starch products could remain on the market for blood volume expansion as long as patients and clinicians are aware of the risks.
The agency advised clinicians to avoid these products in all critically ill patients whatever the diagnosis, in patients undergoing open heart surgery with cardiopulmonary bypass, and in patients with existing renal impairment. Those groups appear to be at highest risk for serious adverse events, the FDA said.
The products should be stopped immediately at the first sign of renal injury, the agency added, and all patients should continue to be monitored for kidney injury for 3 months after discontinuing treatment.
Earlier this month, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee recommended that EU member nations suspend marketing authorizations for the products.
"The suspension should remain in place unless the marketing authorization holder can provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks," according to an EMA press release summarizing the committee's vote.