Fatal Allergic Reactions Linked to Ultrasounds Contrast Agent Containing Polyethylene Glycol (PEG)
Washington, DC – The U.S. Food and Drug Administration issued a warning to ultrasound imaging providers following reports of fatal allergic reactions to certain ultrasound contrast agents. According to the FDA’s warning, the alert involves Definity, Definity RT, and Lumason and its “room temperature formulation,” Bracco’s Lumason.
The FDA has notified healthcare professionals that ultrasound contrast agents Definity, Definity RT and Lumason contain polyethylene glycol (PEG), a chemical that some patients have an immediate hypersensitivity reactions leading to anaphylaxis and death. The FDA has received 11 reports anaphylaxis and two fatalities that appear to be caused by the administration of either Lumason or Definity among patients who are allergic to PEG.
The FDA warns against administering Definity, Definity RT, Lumason, or Bracco’s Lumason to patients with a suspected or known allergy or hypersensitivity to polyethylene glycol (PEG). A new contraindication detailing the risk of anaphylaxis or death due to polyethylene glycol (PEG) allergy or hypersensitivity has been added to the prescribing information for Definity, Definity RT, Lumason, and Bracco’s Lumason ultrasound contrasts.
Ultrasound technicians and other healthcare professionals should clinically assess patients to verify that the ultrasound patient does not have a known or suspected allergy or hypersensitivity to polyethylene glycol (PEG) prior to administering Definity, Definity RT, Lumason, and Bracco’s Lumason ultrasound contrasts. Moreover, some patients may not know that they have a specific allergy to polyethylene glycol (PEG). Ultrasound professionals should ask their patients if they have allergies to common PEG-containing products such as laxatives, or colonoscopy bowel preparations. Furthermore, cardiopulmonary resuscitation (CPR) personnel and Advanced Cardiovascular Life Support (ACLS) equipment should be readily available before the administration of ultrasound contrast agents, and all patients should be watched for signs of a hypersensitivity reaction.
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