FDA: Blood Volume Expanders Present Severe Risks for Patients

Searcy Denney Scarola Barnhart & Shipley
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Searcy Denney Scarola Barnhart & Shipley

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.”

Healthcare Providers Should Not Use HES Products “Unless Adequate Alternative Treatment is Unavailable”

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:

  • Mortality, acute kidney injury and excess bleeding for surgical patients treated with HES products; and,
  • Mortality and acute kidney injury for blunt trauma patients treated with HES products.

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:

  • Hespan
  • Hextend
  • Voluven

Patients Should Follow Up with Their Providers and Report Symptoms Immediately

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:

  • Blood in the urine
  • Changes in amount or color of urine
  • Difficulty urinating or changes in the frequency of urination
  • Nausea or vomiting
  • Swelling in the legs, ankles, feet, hands or face
  • Weakness, fatigue or shortness of breath

Filing a Claim for Injury or Death Resulting From an HES Blood Volume Expander

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. 

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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