"The U.S. Food and Drug Administration today cleared a new screening test that predicts a patient's risk of future coronary heart disease (CHD) events, such as heart attacks.
FDA cleared the test for use in all adults with no history of hear"...
Definity Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Definity (perflutren lipid microsphere) Injectable Suspension is a contrast agent used to brighten and clarify images of the heart during echocardiograms. Common side effects of Definity include injection site reactions, back and chest pain, headache, dizziness, nausea, and flushing.
The recommended dose of Definity is 10 microliters if given via bolus, and 1.3mL if given via infusion. Definity must be administered under a doctor's supervision. Other drugs may interact with Definity. Tell your doctor all medications you take. Before taking Definity tell your doctor if you have heart or lung conditions. If you are pregnant only use Definity if clearly needed. Exercise caution if taking Definity while breastfeeding.
Our Definity (perflutren lipid microsphere) Injectable Suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Definity FDA Prescribing Information: Side Effects
Clinical Trials Experience
A total of 1716 subjects were evaluated in pre-market clinical trials of activated DEFINITY®. In this group, 1063 (61.9%) were male and 653 (38.1%) were female, 1328 (77.4%) were White, 258 (15.0%) were Black, 74 (4.3%) were Hispanic, and 56 (3.3%) were classified as other racial or ethnic groups. The mean age was 56.1 years (range 18 to 93). Of these, 144 (8.4%) had at least one adverse reaction (Table 6.1). There were 26 serious adverse events and 15 (0.9%) subjects discontinued because of an adverse event.
Deaths and Serious Adverse Events
Among the 1716 activated DEFINITY® patients, 19 (1.1%) suffered serious cardiopulmonary adverse events including eight deaths. The deaths occurred several days after activated DEFINITY® administration and appeared to be related to the course of underlying disease. Of the 11 other serious adverse events, which appeared within days of the drug administration (2-15 days), all appeared to be a progression underlying cardiac and non-cardiac disease. However, a role for DEFINITY® in the initiation or course of these adverse events cannot be ruled out.
There were 15 discontinuations reported with a mean age of 41.5 years. Nine of these patients were discontinued after the first injection. One patient experienced a hypersensitivity reaction with urticaria and pruritus and all the other patients experienced dizziness, chest pain, dyspnea or back pain. These adverse reactions appeared within minutes (1 - 15 min) of the drug administration and were of moderate intensity resolving usually without treatment within minutes or hours after onset.
For all adverse reactions, the overall incidence of adverse experiences was similar for the < 65 year age group and the > 65 year age group, similar in males and in females, similar among all racial or ethnic groups, and similar for bolus and infusion dosing. Table 6.1 summarizes the most common adverse reactions.
Table 6.1: New-Onset Adverse Reactions Occurring in
≥ 0.5% of All Activated DEFINITY®-Treated Subjects
|All activated DEFINITY®
|Total Number of Adverse Reactions||269|
|Total Number of Subjects with an Adverse Reaction||144||(8.4%)|
|Application Site Disorders||11||(0.6)|
|Injection Site Reactions||11||(0.6)|
|Body as a Whole||41||(2.4)|
|Central and peripheral nervous system disorder||54||(3.1)|
|Vascular (extracardiac) disorders||19||(1.1)|
|N=Sample size 1716 subjects who
received activated DEFINITY®
n=Number of subjects reporting at least one Adverse Reaction
Other adverse reactions that occurred in ≤ 0.5% of the activated DEFINITY®-dosed subjects were:
Body as a Whole: Fatigue, fever, hot flushes, pain, rigors, and syncope
Platelet, Bleeding, and Clotting: Hematoma
Special Senses: Decreased hearing, conjunctivitis, abnormal vision and taste perversion
Skin: Pruritus, rash, erythematous rash, urticaria, increased sweating, and dry skin
In a prospective, multicenter, open-label registry of 1053 patients receiving DEFINITY® in routine clinical practice, heart rate, respiratory rate, and pulse oximetry were monitored for 30 minutes after DEFINITY® administration. No deaths or serious adverse reactions were reported, suggesting that these reactions are unlikely to occur at a rate of more than 0.3% when DEFINITY® is used according to recommendations.
The following adverse reactions have been identified during the post-marketing use of perflutren-containing microsphere products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Fatal cardiopulmonary and anaphylactoid events and other serious but non-fatal adverse reactions were uncommonly reported. These events typically occurred within 30 minutes of DEFINITY® administration. These serious events 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 [see WARNINGS AND PRECAUTIONS].
Reported Reactions Included
Fatal cardiac or respiratory arrest, shock, syncope, symptomatic arrhythmias (atrial fibrillation, tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia), hypertension, hypotension, dyspnea, hypoxia, chest pain, respiratory distress, stridor, wheezing.
Anaphylactic/anaphylactoid reaction, anaphylactic 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, erythema.
Read the entire FDA prescribing information for Definity (Perflutren Lipid Microsphere)
Additional Definity Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options.