The International Contrast Ultrasound Society (ICUS) urged physicians to use ultrasound contrast agents (UCAs) to enhance conventional ultrasound images where medically appropriate, with customary protocols in place to address rare allergic reactions that may occur in one out of ten thousand doses, announced the society.
The U.S. Food and Drug Administration (FDA) announced that UCAs (sometimes also known as “ultrasound enhancing agents”) should not be administered to patients who are sensitive to polyethylene glycol (PEG), an inactive ingredient in two UCAs approved for use in the United States and other countries throughout the world. PEG also is a component of numerous consumer and medical products.
“Based on the totality of UCA safety data now available, we conclude that UCAs have proven to be safe and beneficial for most patients and the potential for rare reactions, while serious, may be addressed with standard medical precautions,” according to an ICUS statement.
UCAs are radiation-free imaging agents that often improve a physician’s ability to detect heart disease, stratify a patient’s risk of heart attack or stroke, and help identify, characterize and stage tumors of the liver, kidney, prostate, breast and other organ systems. UCAs present no known risk of kidney or liver damage, and are expelled from the body within minutes. In addition, patients do not require sedation during the contrast-enhanced ultrasound (CEUS) exam.
“Contrast enhanced ultrasound, performed with an UCA, provides unique benefits for patients with tumors of their liver or kidney, providing high resolution and results that are often comparable to those obtained with more invasive imaging tests such as CT or MR scans,” according to Dr. Stephanie Wilson, CoPresident of ICUS and expert in the use of CEUS for general imaging. “These examinations provide a less expensive, less invasive and highly successful method of imaging all soft tissue tumors in the abdomen and pelvis.”
In an announcement, the FDA cited reports of adverse events associated with UCAs and PEG sensitivity, including two reported deaths, but information about the patients’ medical history, comorbidities and exposures was not provided. Three UCAs are currently used in the United States –Definity (Lantheus Medical Imaging), Lumason (Bracco) and Optison (GE Healthcare). PEG is an inactive ingredient in Definity and Lumason, and a PEG contra-indication has been added to their product labels.
Physicians are called upon daily to evaluate potential benefits and risks of any diagnostic procedure or therapy, according to the ICUS statement. The organization encourages physicians to carefully weigh the benefits and risks of using UCAs to enhance diagnostic ultrasound exams, along with the risks associated with alternate diagnostic imaging or foregoing diagnostic imaging.
