FDA Warns Certain Ultrasound Contrast Agents Can Lead to Potentially Deadly PEG Allergic Reactions
WASHINGTON D.C. – The Food and Drug Administration (FDA) recently issued a warning to healthcare professionals that certain ultrasound contrast agents such as Definity, Definity RT, and Lumason, contain polyethylene glycol (PEG) and could cause life-threatening allergic reactions in patients with PEG allergies. After the agency reviewed scientific literature, FDA Adverse Event Reporting System (FAERS) reports, and the medication sponsors’ safety analyses, the FDA has added a contraindication for PEG hypersensitivity to the prescribing information for these ultrasound contrast agents.
According to the FDA’s notice, the agency is knowledgeable of immediate hypersensitivity reactions. Eleven of those cases included anaphylaxis and two people tragically passed away due to the administration of Lumason or Definity in patients who had a reported history of a PEG allergy. The FDA is requiring healthcare professionals to clinically evaluate patients for PED allergies prior to administering contrast agents such as Definity, Definity RT, and Lumason. Moreover, since some patients may not know of their PEG allergy, medical professionals are asked to “inquire about allergies to common PEG-containing products.” These products include laxatives and colonoscopy bowel preparations.
The FDA also added to the prescribing information for these contrast agents that both cardiopulmonary resuscitation equipment and personnel must be immediately ready and available prior to ultrasound contrast agent application, and patients must be observed for hypersensitivity reactions.
The FDA will also perform routine monitoring and will monitor ultrasound contrast agents for similar safety concerns. The agency will take the necessary actions to protect the public’s safety. The FDA is also encouraging medical professionals and patients to communicate all adverse events, quality problems, and medication errors experienced to the FDA’s MedWatch Adverse Event Reporting Program.
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