FDA loosens boxed warning on Optison

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Optison echocardiogram, echo - 36.92 Kb
Myocardial contrast echocardiography utilizing intermittent power Doppler imaging triggered at end systole, after injection of a 0.5 ml bolus of Optison. Apical 4 chamber views. Patient with anteroseptal MI treated successfully with thrombolysis. Source: Heart 2003;89:342-348.

The FDA has made product label changes for GE Healthcare's Optison (perflutren protein-type A microspheres injectable suspension), a contrast agent that can be used to visualize the left ventricular border of the heart during echocardiograms.

Currently, 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's March Supplemental New Drug Application for proposed label changes, the FDA revised the prescribing information for Optison including:

  • 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." Similar language also was removed from the Warning section of the label.
  • Addition of the 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.
  • Addition to the Clinical Trials section, describing the results of the Optison pulmonary hemodynamic study.
  • Addition of the further qualifier in the 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."

The current Boxed Warning states: Serious Cardiopulmonary Reactions: Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration.

Optison remains a diagnostic option for patients with suboptimal echocardiograms, according to GE's statement.

The ultrasound community has been advocating for changes to the labeling since a Black Box Warning was slapped on the contrast agents in October 2007. Thus, the International Contrast Ultrasound Society (ICUS) "applauded" the FDA’s decision to modify the U.S. product label for Optison in a statement. According to the society, the label change was supported by a Citizen Petition filed by ICUS, citing newer scientific studies showing the superior safety profile of ultrasound contrast agents along with their favorable risk-benefit ratios. The Citizen Petition also supported a prior modification of the label for Definity, an ultrasound contrast agent marketed by Lantheus Medical Imaging.

For historical perspective, please read our article in Cardiovascular Business from November 2008.