Ultrasound companies say ‘no change’ to contrast agent policy


The American Institute of Ultrasound in Medicine (AIUM), the American Society of Echocardiography (ASE) and the International Contrast Ultrasound Society (ICUS) have issued statements in response to the FDA following a warning issued by the ‘agency after 11 reported cases of anaphylaxis and two deaths in patients, apparently as a reaction to polyethylene glycol, an ingredient in Definity and Lumason.

The companies wrote that such reactions are “extremely” rare and that the 13 cases identified by the FDA were derived from historical data representing millions of doses of ultrasound contrast agents administered over more than a decade.

They also highlighted the clinical benefits of using contrast agents. These include helping detect heart disease, classifying the risk of heart attack or stroke, identifying abdominal tumors, and monitoring the effectiveness of cancer therapies in adults and children.

“The FDA alert does not contain any information that would justify changes in the laboratory’s policy for monitoring patients or algorithms for treating hypersensitivity reactions,” the ASE said in its statement. “The use of these agents should continue in situations where they have been shown to have an impact.”

Ultrasound contrast agents are radiation-free and improve conventional ultrasound scans, often producing images with a higher resolution than more expensive imaging options such as CT or MRI, which come with their own risks, according to the company. ICUS.

The benefits of contrast enhanced ultrasound (CEUS) include reduced downstream testing, which can in turn reduce overall imaging costs, speed up patient diagnosis and treatment, and improve patient workflows. hospital, according to the AIUM response.

Polyethylene glycol is an inactive ingredient in contrast agents. It can also be found in “thousands” of enteral and parenteral drugs, including drugs commonly used in cardiovascular medicine, according to the ESA response, led by President Dr. Jonathan Lindner.

“It is also a component of the COVID-19 journal’s pre-sealed vaccines based on mRNA technology, and is present in many skin creams, cosmetics and household products,” wrote Lindner and his team. .

The companies also pointed out that there was no apparent confirmation or data in the FDA statement to show whether the 13 suspected reactions to polyethylene glycol were caused by other conditions or exposures.

Lindner and her team said training sonographers, nurses and doctors on hypersensitivity reactions is an established recommendation.

However, the companies also acknowledged that the FDA alert “improved” their understanding of the mechanism of reactions to contrast agents.

“Reactions to polyethylene glycol, although extremely rare, must be considered alongside the obvious benefits of CEUS,” AIUM said in a statement.

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