On July 7, 2021, the U.S. Food and Drug Administration (FDA) issued new warnings regarding hydroxyethyl starch (HES) blood volume expanders. Specifically, the FDA is now requiring manufacturers to update the safety labels for these products, “to warn about the risk of mortality, kidney injury, and excess bleeding.”
Based on a review of clinical trials and other studies, the FDA has identified a number of serious risks associated with HES blood volume expanders. These include risks for surgical patients and patients seeking treatment for blunt trauma. According to the FDA, the data it reviewed showed an increased risk of:
In light of these risks, the FDA is advising health professionals not to use HES blood volume expanders, “unless adequate alternative treatment is unavailable.” This applies to all three brands of FDA-approved HES products:
In addition to issuing an advisory to HES product manufacturers and healthcare providers, the FDA is providing guidance to patients as well. It is encouraging all patients who have received HES blood volume expanders to follow up with their healthcare providers as requested and report “any unusual symptoms” immediately. This includes symptoms of acute kidney injury such as:
If you or a loved one has been diagnosed with complications from an HES blood volume expander following surgery or treatment for blunt trauma, you should speak with a Florida product liability lawyer about your legal rights. The FDA first required manufacturers to place a “black box” warning on HES products in 2013, and the risks associated with these products have been well-known for some time. Yet, manufacturers continue to produce them, and many healthcare providers continue to recommend them to their patients.
Patients and families that have suffered losses due to the well-known risks associated with HES blood volume expanders will be entitled to financial compensation in many cases.