Following a review of GE's supplemental new drug application (NDA) for proposed label changes, the U.S. Food and Drug Administration (FDA) has revised several elements of the prescribing information for Optison, including the following:
- Removal of the following 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." Similar language was also removed from the warning section of the label.
- Addition of the following statement to the boxed warning: "Most serious reactions occur within 30 minutes of administration," which is consistent with current information included in the warning section, GE said.
- Addition of language to the clinical trials section that describes the results of the Optison pulmonary hemodynamic study.
- Addition of a further qualifier in this statement in the warning section: "Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or shortly following perflutren-containing microsphere administration, typically within 30 minutes of administration."