Safety Label Changes for Optison Suspension
The FDA has approved updated labeling for GE Healthcare's Optison (perflutren protein-type A microspheres injectable suspension) that modifies the product's safety and patient monitoring requirements.
Major changes include:
- Removal of the statement from within the previous boxed warning: “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.”
- Addition to the boxed warning stating that most serious reactions occur within 30 minutes of administration
- Addition to the clinical trials section describing results of the Optison pulmonary hemodynamic study
- Addition to the warning section specifying that serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or shortly following perflutren-containing microsphere administration.
Optison is a contrast agent that may improve the visualization of the left ventricular border 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.
For more information call (866) 281-7545 or visit www.optisonimaging.com.