The FDA has added a contraindication for use of ultrasound contrast in patients with PEG allergies to the labeling information for three commercially available agents: Lumason from Bracco and Definity and Definity RT from Lantheus Medical Imaging, according to the ACR.
The ACR said in a statement that the FDA was aware of over a dozen allergic reactions to ultrasound contrast, including 11 cases of anaphylaxis and two patient deaths. The agency believed the cases were related to the use of ultrasound contrast in patients with histories of PEG allergies.
The ACR went on to advise that healthcare professionals confirm that patients do not have a history of PEG allergies before administering ultrasound contrast to them. Many patients aren't aware of their PEG allergic status, so the ACR advised that providers ask if they have had reactions to products like colonoscopy bowel preparations and laxatives.
The FDA is encouraging providers to report adverse events to its MedWatch adverse event reporting page.
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