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"Sometimes echocardiograms in certain patients are difficult for physicians to see and interpret," said Libero Marzella, M.D., Ph.D., director of the Division of Medical Imaging Products in the FDA's Center for Drug Evaluation and Research, in a . "Today's approval provides doctors with another option when performing contrast enhanced ultrasound."
The safety and effectiveness of the drug was tested in three clinical trials, which included 191 patients. All of them had suspected cardiac disease and their echocardiograms were difficult to read and interpret.
Researchers noted that in all three trials, doctors were able to clearly see the lining of the left ventricle. Lumason also aided in visual improvement observed in the majority of the patients who received a 2 milliliter dose of the agent.
The ultrasound imaging agent comes with a boxed warning, alerting people of the risk of serious cardiopulmonary reactions, including fatal cardiac or respiratory arrest. The risk of these reactions is high among patients with certain heart conditions; most serious reactions occur within 30 minutes of administration.
The most commonly reported side effects associated with Lumason were headache and nausea.
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