Benefits Of Ultrasound Contrast Agents Outweigh Potential Risk To Heart Patients

A Saint Louis University cardiologist called upon the U.S. Food and Drug Administration (FDA) 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.

source: Medical News Today