April 22, 2021

FDA Warns Against Some Ultrasound Contrast Agents in Patients with PEG Allergy

The federal Food and Drug Administration (FDA) is notifying healthcare professionals that the ultrasound contrast agents Definity, Definity RT and Lumason contain polyethylene glycol (PEG) and should not be administered to patients with known or suspected allergies to PEG. Following the FDA’s review of scientific literature, reports submitted to the FDA Adverse Event Reporting System (FAERS), and the drug sponsors’ safety analyses, a contraindication for PEG hypersensitivity has been added to the prescribing information for the respective drugs.

The FDA is aware of immediate hypersensitivity reactions, including 11 cases of anaphylaxis and two deaths, which appear related to the administration of either Definity or Lumason among patients with a reported history of PEG allergy.

Healthcare professionals should clinically assess patients to confirm they do not have a known or suspected allergy to PEG before administering Definity, Definity RT and Lumason. Since patients may be unaware of a specific allergy to PEG, healthcare professionals should inquire about allergies to common PEG-containing products such as certain colonoscopy bowel preparations and laxatives. As noted in the prescribing information for these drugs, cardiopulmonary resuscitation personnel and equipment should also be readily available prior to ultrasound contrast agent administration, and all patients should be monitored for hypersensitivity reactions.

As part of the FDA’s routine monitoring, we will continue to monitor ultrasound contrast agents for safety issues and will take appropriate action to protect public health. The FDA encourages healthcare professionals and patients to report adverse events, medication errors or quality problems experienced with the use of any medication to the FDA’s MedWatch Adverse Event Reporting program:

  • Complete and submit the report online; or
  • Download and complete the form, then submit it via fax at 1-800-FDA-0178.