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FDA Warns of Mortality, Kidney Risks Associated with Hydroxyethyl Starch (HES) Solutions

Jun 25, 2013

Federal health officials have added new warnings to labels of Hydroxyethyl starch (HES) solutions to indicate dangers posed to certain patients.

According to a communication from the U.S. Food and Drug Administration (FDA), using HES solution therapy in critically ill patients could result in mortality or kidney injuries that may require renal replacement therapy. A Boxed Warning has been added to the label of HES solutions to indicate these risks. The FDA has also added warnings to indicate a bleeding risk linked to patients treated with HES solutions who’ve undergone open heart surgery in association with cardiopulmonary bypass.

HES solutions are often prescribed to treat patients with a low blood volume, a condition known as hypovolemia.

The FDA says these added warnings are the result of a Public Workshop the agency convened last September that was investigating the safety of HES solutions. After analyzing the data collected at the workshop, the agency determined that HES solutions should not be used among critically ill patients, including patients with sepsis and those admitted to hospital intensive care units.

The Boxed Warning added to these HES solutions is the agency’s most serious. In addition to this warning, the results of that workshop also led the FDA to add more warnings to the Safety and Precautions section of the HES solution labels. These warnings note the risk of excessive bleeding when the solutions are used in patients who’ve undergone open heart surgery in association with cardiopulmonary bypass.

Regulators warn patients who use HES solutions to be alert for signs of kidney injuries and to discuss the safety concerns. Some symptoms of kidney injuries that could result from use of HES solutions include change in the frequency, amount, and color of their urine, as well as blood in the urine. Patients who have difficulty urinating may also be experiencing kidney injuries associated with use of an HES solution. Other symptoms of injury could include swelling of the legs, ankles, feet, face, or hands, as well as weakness and fatigue, nausea, vomiting, and shortness of breath.

For physicians who might prescribe an HES solution, the FDA recommends that they avoid using them in critically ill patients, including those with sepsis. Additionally, a pre-existing kidney dysfunction should disqualify someone from receiving an HES solution. The agency notes that renal replacement therapy is often needed within 90 days of starting an HES solution, and that physicians should monitor kidney function during this time in patients who receive the solution.

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