ST. LOUIS A Saint Louis University cardiologist called upon the U.S. Food and Drug Administration (FDA) today to reconsider a strong warning it recently placed on a diagnostic tool, stating that the warning could prevent doctors from detecting life-threatening cardiac events.
In October 2007, the FDA placed a black box warning on ultrasound contrast agents, which are used to improve the quality of echocardiography images in patients who do not otherwise have optimal images, after receiving reports of four deaths and serious reactions shortly after or during the infusion.
A black box warning is given to drugs that carry a significant risk of serious or even life-threatening adverse effects. The warning placed on ultrasound contrast agents was issued without a formal examination of the risks and benefits of using them, says Melda Dolan, M.D., associate professor of cardiology at Saint Louis University School of Medicine.
Dolans research shows that the contrast agents are indeed safe, and withholding their use, which has occurred since the FDA warning, would make diagnosis of life-threatening heart disease more difficult.
Based on the results of our study, we believe the FDA should reconsider its stance on contrast agents because the benefits outweigh the potential, although not established, risk, says Dolan, who is the primary investigator of the study.
Dolan presented the research findings today at the 57th annual American College of Cardiology Scientific Session in Chicago, Ill.
Routinely used to determine the strength of the heart, echocardiography enables cardiologists to monitor a patients cardiac function, determine if treatment plans are working and can be used to pursue further modes of therapy. However, various factors can prevent the echocardiogram from obtaining optimal images.
In 1997, after significant scrutiny, the FDA approved the use of ultrasound contrast agents, which are ga
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Saint Louis University