NEW STUDY RAISES MORE CONCERNS ABOUT PATIENT SAFETY

CHICAGO, ILLINOIS -- An alarming new study published in the January 23 issue of Archives of Internal Medicine raises serious concerns about the apparent link between exposure to iodinated contrast media and changes in thyroid function, with a higher risk of developing hyperthyroidism.

The study is the largest of its kind and is especially concerning given the fact that contrast media use has soared in the past two decades. More patients than ever are being exposed to high iodide loads, as well as potentially harmful radiation The International Contrast Ultrasound Society (ICUS) has been a relentless advocate for Contrast Enhanced Ultrasound (CEUS) as a safer alternative to the traditional types of diagnostic testing that expose patients to large amounts of ionizing radiation. “This study should be yet another wake-up for the medical community, government regulators and the patients they serve,” said Dr. Gary Goldberg, Co-President of ICUS.

Dr. Goldberg believes that the time has come for greater expansion of the use of CEUS. He added, “CEUS is safe, accurate, and eliminates exposure to ionizing radiation altogether. It is long past time for the medical world to pivot to this better imaging tool.”

Dr. Steve Feinstein, Co-President of ICUS added, “the shocking results of this study puts the issue of patient safety front and center. CEUS produces better imaging with significantly less risk to patients.” Feinstein went on to say “This study has to make the FDA sit up and take notice.” CEUS is used in Europe, Asia, Canada and Brazil for early detection of tumors and evaluating abnormalities throughout the body, including the heart, liver, brain, digestive tract, and kidneys. The United States Food and Drug Administration has only approved the use of ultrasound contrast agents for certain forms of cardiac imaging and are limited to the left ventricle of the heart and endocardial borders.

FDA approval of additional applications, including ultrasonic detection of liver tumors, is under consideration. Early safety concerns prompted the FDA to require boxed warnings on the two ultrasound contrast agents approved for use in the United States -- Definity, sold by Lantheus, and Optison, sold by GE Healthcare. However, since the boxed warnings were imposed in late 2007, an overwhelming amount of favorable safety data has been produced by medical centers worldwide, according to Dr. Feinstein.

"These new studies and data clearly show that CEUS is extremely safe, and that clearer ultrasound images improve the accuracy of diagnosis and treatment while reducing the need for riskier and more expensive downstream testing," Feinstein said. “This is clearly a case where reimbursement policy and politics has gotten out ahead of good medicine.”

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