April 29, 2017
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Optison

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Optison




Optison Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 3/21/2016

Optison (perflutren protein-type A microspheres) Injectable Suspension consists of microspheres of human serum albumin with perflutren for contrast enhancement used during certain ultrasound imaging procedures. Common side effects of Optison include:

  • headache
  • nausea
  • vomiting
  • warm sensation or flushing
  • dizziness
  • chills
  • fever
  • weakness
  • fatigue
  • malaise
  • chest pain
  • shortness of breath
  • redness
  • changes in taste.
The recommended dose of Optison is 0.5 mL injected into a peripheral vein. This may be repeated for further contrast enhancement as needed. Optison may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Optison should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

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.

Optison FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Optison was administered in clinical studies in 279 patients. Of these patients there were 192 (68.8%) men and 87 (31.2%) women. The racial demographics were 199 (71.3%) Caucasian, 52 (18.6%) Black, 24 (8.6%) Hispanic, and 4 (1.4%) other racial or ethnic groups.

In these patients, 47 (16.8%) reported at least one adverse reaction. Of these one reaction was serious and required treatment with antihistamines for hypersensitivity manifestations of dizziness, nausea, flushing and temperature elevation. Deaths were not reported during the clinical studies.

Of the reported adverse reactions following the use of Optison the most frequently reported were headache (5.4%), nausea and/or vomiting (4.3%), warm sensation or flushing (3.6%), and dizziness (2.5%). The most common adverse reactions observed in clinical studies of Optison are given in Table 1.

Table 1 :SELECTED ADVERSE REACTIONS REPORTED IN ≥ 0.5% OF THE SUBJECTS WHO RECEIVED OPTISON™ IN CONTROLLED CLINICAL STUDIES)

No. of Patients Exposed to Optison 279
No. of Patients Reporting on Adverse Reactions 47 (16.8%)
Body as a Whole 38 (13.6%)
Headache 15 (5.4%)
Warm Sensation/Flushing 10 (3.6%)
Chills/fever 4 (1.4%)
Flu-like Symptoms 3 (1.1%)
Malaise/Weakness/Fatigue 3 (1.1%)
Cardiovascular System 12 (4.3%)
Dizziness 7 (2.5%)
Chest Pain 3 (1.1%)
Digestive System 12 (4.3%)
Nausea and/or Vomiting 12 (4.3%)
Nervous System 3 (1.1%)
Respiratory System 5 (1.8%)
Dyspnea 3 (1.1%)
Skin & Appendages 11 (3.9%)
Injection Site Discomfort 3 (1.1%)
Erythema 2 (0.7%)
Special Senses 9 (3.2%)
Altered Taste 5 (1.8%)
(1) Patients are counted separately within each body system.
(2) The body system is reported if the aggregate is ≥ 0.5%. Details are not shown if the subsystem is not ≥ 0.5%.

Adverse reactions reported in < 0.5% of subjects who received Optison included: arthralgia, back pain, body or muscle aches, induration, urticaria, dry mouth, palpitations, paresthesia, photophobia, premature ventricular contraction, pruritus, rash, irritableness, hypersensitivity, tinnitus, tremor, visual blurring, wheezing, oxygen saturation decline due to coughing, discoloration at the injection site, and burning sensation in the eyes.

Postmarketing Experience

In a prospective, post-marketing safety surveillance study of Optison used in routine clinical practice, a total of 1039 subjects received Optison. Of these patients, 648 (62.4%) were male and 391 (37.6%) were female with average age of 59.9 years (min, max: 20, 97). The racial distributions were 864 (83.2%) White, 141 (13.6%) Black, 18 (1.7%) Asian, and 16 (1.5%) other racial or ethnic groups. Overall, 175 patients (16.8%) reported at least one adverse event. No serious adverse reactions, including deaths, were reported in this study.

The following adverse reactions have been identified during the postmarketing use of Optison. 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.

Cardiac arrests and other serious but non-fatal adverse reactions were uncommonly reported. Most of these reactions included cardiopulmonary symptoms and signs such as cardiac arrest, hypotension, supraventricular and ventricular arrhythmias, respiratory distress or decreased oxygenation. Reports also identified neurologic reactions (loss of consciousness or convulsions) as well as hypersensitivity reactions [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Optison (Perflutren Protein-Type A Microspheres)

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.


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