GE Healthcare Announces Updates To Optison Prescribing Information

Main Category: MRI / PET / Ultrasound
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 12 Jun 2008 - 0:00 PDT

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GE Healthcare announced significant updates to the Prescribing Information (PI) for its ultrasound contrast medium OPTISON TM (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 U.S. 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 8 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 U.S. 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 http://www.gehealthcare.com. This information is also being provided in a letter to healthcare providers.

About Optison

OPTISONTM, an ultrasound contrast agent based on a natural protein shell filled with the inert gas perflutren, is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular borders. The safety and efficacy of OPTISON with exercise stress or pharmacologic stress testing have not been established .

Important safety information about Optison

Warning: Serious Cardiopulmonary Reactions

Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutrencontaining microsphere administration. Assess all patients for the presence of any condition that precludes OPTISON administration (see CONTRAINDICATIONS). 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 (see WARNINGS). Always have resuscitation equipment and trained personnel readily available.

Contraindications:

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, blood, blood products or albumin (see WARNINGS)
Do not administer OPTISON by intra-arterial injection.

Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutren-containing microsphere administration. The risk for these reactions may be increased among patients with pulmonary hypertension or unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias or respiratory failure, including patients receiving mechanical ventilation). In these patients, monitor vital signs, electrocardiography, and cutaneous oxygen saturation during and for at least 30 minutes after OPTISON. In the absence of these underlying conditions, observe patients closely during and following OPTISON administration.

In postmarketing use, uncommon but serious reactions observed during or shortly following perflutren-containing microsphere administration included cardiac or respiratory arrest, loss of consciousness, convulsions, symptomatic arrhythmias (atrial fibrillation, supraventricular tachycardia, ventricular tachycardia or fibrillation), hypotension, respiratory distress or cardiac ischemia (see ADVERSE REACTIONS).

For full prescribing information, and to read the boxed warning, please visit http://www.gehealthcare.com

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.

GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries.

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