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FDA Approves Labeling Changes for GE Healthcare’s Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)

Tue, 08/21/2012 - 8:00am
The Associated Press

PRINCETON, N.J.--(BUSINESS WIRE)--Aug 21, 2012--GE Healthcare today announced important changes to the U.S. product label for Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a contrast agent that may improve the visualization of the left ventricular border – an area of the heart that is critical to see 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.

Optison is not for use in patients with known or suspected: (1) Right-to-left, bi-directional, or transient right-to-left cardiac shunts, or (2) hypersensitivity to perflutren, blood, blood products or albumin. It should not be administered by intra-arterial injection.

BOXED WARNING: 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.

Assess all patients for the presence of any condition that precludes Optison administration. Always have resuscitation equipment and trained personnel readily available.

After a review of GE Healthcare’s March 2012 Supplemental New Drug Application for proposed label changes, the U.S. Food and Drug Administration (FDA) made revisions to 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 was also 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.” “GE Healthcare is committed to providing safe, innovative and effective medical products that aid in the detection of cardiovascular diseases, and we are pleased that the FDA label change supports this goal,” said Mark Gelder, Global Head, Medical Affairs and Clinical Development, GE Healthcare Medical Diagnostics. “The approved Optison labeling revisions are based on data from clinical and surveillance studies and more than 12 years of post-marketing clinical experience which found no statistically significant risks or safety signals. The revised label may increase access of Optison in critically ill patients who may receive the most benefit from contrast-enhanced echocardiography.” The most frequently reported adverse reactions following clinical trial use of Optison were headache, nausea and/or vomiting, warm sensation or flushing, and dizziness. Cardiac arrests and other serious, but non-fatal adverse reactions were uncommonly reported post-marketing. Most of these uncommon reactions included cardiopulmonary symptoms and signs such as cardiac or respiratory arrest, hypotension, supraventricular and ventricular arrhythmias, respiratory distress or decreased oxygenation. Reports also identified neurologic reactions (loss of consciousness or convulsions) as well as anaphylactoid reactions.

Optison remains an important diagnostic option for patients with suboptimal echocardiograms.

Additionally, Optison offers a unique, convenient value to clinicians and patients – it is stable at room temperature for up to 24 hours and takes less than 60 seconds to prepare, allowing for quick access to contrast in the lab, trauma situations or during transport from one hospital campus to another. Optison is for single use only. Follow labeled instructions for product handling and use and discard unused product properly.

"The revised product labeling for Optison better reflects the known safety profile of this agent, and should encourage ultrasound contrast agent use in patients most likely to realize the greatest incremental diagnostic benefit--hospitalized patients with critical illnesses, including those with known significant cardiopulmonary disease,” said Michael L. Main, MD Medical Director, Cardiovascular Ultrasound Imaging Laboratory, St. Luke’s Mid-America Heart Institute, Kansas City, MO.

About Optison™ Important Risk and Safety Information about Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) BOXED WARNING: 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. Assess all patients for the presence of any condition that precludes Optison administration. Always have resuscitation equipment and trained personnel readily available.

INDICATIONS: Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. CONTRAINDICATIONS: Do not administer Optison to patients with known or suspected: (1) Right-to-left, bi-directional, or transient right-to-left cardiac shunts, or (2) Hypersensitivity to perflutren, blood, blood products or albumin. Do not administer Optison by intra-arterial injection. WARNINGS:Anaphylactoid Reactions: In postmarketing use, uncommon but serious anaphylactoid reactions were observed during or shortly following perflutren-containing microsphere administration, including in patients with no prior exposure to perflutren-containing microsphere products. HighUltrasound Mechanical Index: High ultrasound mechanical index values may cause microsphere cavitation or rupture and lead to ventricular arrhythmias. Additionally, end-systolic triggering with high mechanical indices has been reported to cause ventricular arrhythmias. The safety of Optison at mechanical indices greater than 0.8 and the safety of Optison with the use of end-systolic triggering have not been evaluated. PRECAUTIONS: General: Optison contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral disease and Creutzfeldt-Jakob disease (CJD), no cases of which have ever been identified for albumin. Pregnancy: Adequate or well-controlled studies were not conducted in pregnant women. Optison should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when Optison is administered to a nursing woman. Pediatric Use: Safety and efficacy have not been established in pediatric patients, or in patients with congenital heart disease. ADVERSEREACTIONS: The most frequently reported adverse reactions following clinical trial use of Optison were headache, nausea and/or vomiting, warm sensation or flushing, and dizziness. PostmarketingExperience: Cardiac arrests and other serious, but non-fatal adverse reactions were uncommonly reported. Most of these uncommon reactions included cardiopulmonary symptoms and signs such as cardiac or respiratory arrest, hypotension, supraventricular and ventricular arrhythmias, respiratory distress or decreased oxygenation. Reports also identified neurologic reactions (loss of consciousness or convulsions) as well as anaphylactoid reactions.

Prior to Optison administration, please read the Full Prescribing Information available at . About GE Healthcare GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.

Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality and efficiency around the world. 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. For more information about GE Healthcare, visit our web site at www.gehealthcare.com.

CONTACT: GE Healthcare Aleisia Gibson 609 514 6046 (office) 201 289 3832 (mobile) Aleisia.Gibson@ge.com KEYWORD: UNITED STATES NORTH AMERICA NEW JERSEY INDUSTRY KEYWORD: HEALTH CARDIOLOGY PHARMACEUTICAL FDA SOURCE: GE Healthcare Copyright Business Wire 2012 PUB: 08/21/2012 08:00 AM/DISC: 08/21/2012 08:00 AM http://www.businesswire.com/news/home/20120821005520/

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