GE Healthcare, the healthcare business of General Electric Co. (GE), announced important changes to the U.S. product label for Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a contrast agent that may improve the visualization of the left ventricular border - an area of the heart that is critical to see in order to diagnose certain heart diseases such as hypertrophic cardiomyopathy.
Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve delineation of the left ventricular endocardial borders. Optison is not for use in patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts, or hypersensitivity to perflutren, blood, blood products or albumin. It should not be administered by intra-arterial injection.
After a review of GE Healthcare's March 2012 Supplemental New Drug Application for proposed label changes, the U.S. Food and Drug Administration, or FDA, made revisions to the Prescribing Information for Optison, including removal of the statement, "In patients with pulmonary hypertension or unstable cardiopulmonary conditions, monitor vital sign measurements, electrocardiography and cutaneous oxygen saturation during and for at least 30 minutes after Optison administration", from within the previous BOXED WARNING. Similar language was also removed from the WARNING section of the label.
FDA further added statement, "Most serious reactions occur within 30 minutes of administration", to the BOXED WARNING.
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