Optison is the only FDA-approved ultrasound enhancing agent (UEA) in the United States that does not contain polyethylene glycol (PEG).
Recently PEG has been in the spotlight and we wanted to help answer some questions you may have.
The Food and Drug Administration (FDA) has notified healthcare professionals that three of the currently four available UEAs contain PEG and should not be administered to patients with known or suspected allergies to PEG. The companies that manufacture these PEG-containing UEAs have been required to add a contraindication and update the hypersensitivity reactions section of their UEA Prescribing Information.¹ The FDA is aware of immediate hypersensitivity reactions, including 11 cases of anaphylaxis and two deaths, which appear related to the administration of PEG-containing UEAs among patients with a reported history of PEG allergy.¹
The PEG contraindication is not a class effect for all UEAs. Optison is the only UEA in the United States that does not contain PEG.
Please see to the right Important Safety Information about Optison, including Boxed Warning. For further information about Optison, please see the Full Prescribing Information here.
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Reference:
1. American College of Radiology (ACR). https://www.acr.org/Advocacy-andEconomics/Advocacy-News/Advocacy-News-Issues/In-the-April-24-2021-Issue/FDA-Warns-Against-Some-Ultrasound-Contrast-Agents
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May 2021 JB05244US