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GE Healthcare has announced significant updates to the prescribing information (PI) for its ultrasound contrast medium OPTISON™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP).

The company also announced that it will establish an external, independent safety monitoring board for Optison.

These changes come after a recent US Food and Drug Administration (FDA) safety review, in which the Agency revised the benefit/risk assessment for all perflutren microsphere contrast agents.

Changes to the prescribing information include removal of certain contraindications for the use of Optison in critically ill patients, which will enable physicians to use the agent to diagnose potentially life-threatening cardiac abnormalities. Additional changes include the removal of extensive monitoring requirements post-injection, in all but critically ill patients.

The contraindication section of the label has been revised to state: "Do not administer Optison to patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts, hypersensitivity to perflutren. Do not administer Optison by intra-arterial injection." All other contraindications have been removed from the Optison label. The boxed WARNING and WARNINGS sections have been revised to recommend monitoring in patients with pulmonary hypertension or unstable cardiopulmonary conditions only. The previous label had included language regarding monitoring in all patients.

More than one million doses of Optison have been administered in the past eight years. "New studies underscore the safety of contrast ultrasound, consistent with our clinical experience," said Dr. Steven Feinstein, professor of medicine and director of the echocardiography laboratory at Rush University Medical Center in Chicago.

"First and foremost, GE Healthcare is committed to the safety of patients receiving our products and in keeping our customers well-informed about using them safely and effectively," said Anders Wold, general manager of GE Healthcare's cardiovascular ultrasound business. "We are pleased with the FDA's decision, especially in light of the level of advocacy that was shown by medical professionals around the world."

Optison returned to the US market in October 2007 after a nearly two-year absence due to a voluntary recall related to manufacturing issues. GE Healthcare conducted a medical evaluation of the circumstances surrounding this recall and concluded, with FDA agreement, that the probability of serious adverse events related to the use of the product was remote.

More information about the label change can be found at www.gehealthcare.com. This information is also being provided in a letter to healthcare providers.