GE Healthcare Receives FDA Approval for Change in Contraindications in Prescribing Information for OptisonTM
05 October 2021 - 10:15PM
Business Wire
GE Healthcare announced today that it has received approval from
the U.S. Food and Drug Administration (FDA) to remove
hypersensitivity to ‘blood and blood products’ from the
contraindications in its prescribing information for its product
OptisonTM (Perflutren Protein-Type A Microspheres Injectable
Suspension, USP).
Optison is an ultrasound enhancing agent (UEA) that can improve
the visualization of the left ventricular border ─ an area of the
heart that is critical to see in order to help assess heart
conditions. It 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.
As a result of the FDA decision, the contraindications on the
prescribing information for Optison have now been changed from:
- “Do not administer Optison to patients with known or suspected
hypersensitivity to perflutren, blood, blood products or
albumin”
To:
- “Do not administer Optison to patients with known or suspected
hypersensitivity to perflutren or albumin”
Marco Campione, General Manager Americas for GE Healthcare,
said: “More than three million patients have received Optison since
it was approved by the FDA in 1997. During that time, there have
been no reported cases of blood or blood product hypersensitivity
reactions. No other albumin products on the market have this
contraindication. We are pleased, therefore, that the FDA has made
this decision.”
Jonathan R. Lindner, MD, M. Lowell Edwards Professor of
Medicine, Chief, ONPRC Division of Cardiometabolic Health, Oregon
Health & Science University, said: “Ultrasound enhancing agents
(UEAs) have been shown to improve patient care through improved
diagnostic accuracy and greater confidence in interpretation of
echocardiograms. Accordingly, the peeling away of precautions or
contraindications for the use of UEAs that are not supported by
science removes unnecessary hurdles to employing this valuable
asset in cardiovascular imaging.”
Removing the need to screen for hypersensitivity to blood and
blood products will help to improve workflow efficiency for
clinicians. As the FDA has never classified Optison as a blood
product - it has always been classified as a medical imaging drug
product - there continues to be no related religious-based
objection, and no additional patient consent is required.
Please see additional Important Safety Information About Optison
on page 3, and Full Prescribing Information at
tinyurl.com/OptisonPI2021.
GE Healthcare has a legacy of industry-defining innovations in
ultrasound including having introduced the world’s first high
resolution 4D fetal ultrasound system, the first handheld
ultrasound and the world’s first ultrasound optimized for AI.
About GE Healthcare: GE Healthcare is the $18 billion
healthcare business of GE (NYSE: GE). As a leading global medical
technology, pharmaceutical diagnostics and digital solutions
innovator, GE Healthcare enables clinicians to make faster, more
informed decisions through intelligent devices, data analytics,
applications and services, supported by its Edison intelligence
platform. With over 100 years of healthcare industry experience and
around 47,000 employees globally, the company operates at the
center of an ecosystem working toward precision health, digitizing
healthcare, helping drive productivity and improve outcomes for
patients, providers, health systems and researchers around the
world.
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About Optison: Optison was the first ultrasound enhancing
agent (UEA) introduced to the market over 20 years ago. It helps
clinicians to better visualize the left ventricle in previously
suboptimal echocardiograms. It can enhance image quality of the
left ventricle and the endocardial borders compared to unenhanced
images. It also helps workflow efficiency related to preparation,
administration, portability and storage attributes. Optison is
stable at room temperature for up to 24 hours and is quick to
prepare, allowing for quick access to the UEA in hospital settings
like the echo lab, intensive care unit or emergency room. It has a
well-established safety profile, and is the only UEA in the US that
does not contain polyethylene glycol (PEG). PEG containing UEAs are
contraindicated for patients with hypersensitivity to PEG. Optison
does not contain preservatives and is for single patient use only.
Healthcare professionals should follow labelled instructions for
product handling and use and discard unused product properly.
Optison is not for use in patients with known or suspected
hypersensitivity to perflutren or albumin. As for all ultrasound
enhancing agents, Optison has a Boxed Warning indicating that
serious cardiopulmonary reactions, including fatalities, have
occurred uncommonly during or following perflutren-containing
microsphere administration. Most serious reactions occur within 30
minutes of administration. Healthcare professionals should assess
all patients for the presence of any condition that precludes
Optison administration and always have resuscitation equipment and
trained personnel readily available.
More information about Optison is available here:
https://www.gehealthcare.com/products/contrast-media/optison
………………………………………………………….
INDICATION AND USAGE
OPTISON (Perflutren Protein-Type A Microspheres Injectable
Suspension, USP) 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.
IMPORTANT SAFETY INFORMATION
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
- CONTRAINDICATION: Do not administer OPTISON to patients
with known or suspected hypersensitivity to perflutren or
albumin.
- WARNINGS AND PRECAUTIONS: Serious cardiopulmonary
reactions, including fatalities, have occurred uncommonly during or
shortly following administration. The risk for these reactions may
be increased among patients with unstable cardiopulmonary
conditions (acute myocardial infarction, acute coronary artery
syndromes, worsening or unstable congestive heart failure, or
serious ventricular arrhythmias).
- Serious anaphylactic reactions have been observed during or
shortly following perflutren-containing microsphere administration,
including shock, hypersensitivity, bronchospasm, throat tightness,
angioedema, edema (pharyngeal, palatal, mouth, peripheral,
localized), swelling (face, eye, lip, tongue, upper airway), facial
hypoesthesia, rash, urticaria, pruritus, flushing, and erythema
have occurred in patients with no prior exposure to
perflutren-containing microsphere products.
- When administering OPTISON to patients with a cardiac shunt,
microspheres can bypass filtering of the lungs and enter the
arterial circulation. Assess patients with shunts for embolic
phenomena following OPTISON administration.
- High ultrasound mechanical index values may cause microsphere
rupture and lead to ventricular arrhythmias. Additionally,
end-systolic triggering with high mechanical indices has been
reported to cause ventricular arrhythmias. OPTISON is not
recommended for use at mechanical indices greater than 0.8.
- This product 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.
- ADVERSE EVENTS: The most frequently reported adverse
reactions in clinical trials were headache, nausea and/or vomiting,
warm sensation or flushing and dizziness. Cardiac arrests and other
serious but nonfatal adverse reactions were uncommonly reported in
post-approval use. Reports also identified neurologic reactions
(loss of consciousness or convulsions) as well as anaphylactoid
reactions.
Please see the full Prescribing Information at
tinyurl.com/OptisonPI2021, including Boxed Warning for
additional important safety information.
To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare
at 800 654 0118 (option 2, then option 1), or the FDA at 800 FDA
1088 or www.fda.gov/medwatch
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Media Contact: Debbie Leven Debbie.Leven@ge.com +44 7785
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