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FDA Date: 7/17/08
Optison (perflutren protein-type A microspheres for injection) FDA Drug Safety Communication
Information for Healthcare Professionals: Micro-bubble Contrast Agents (marketed as Definity and Optison)
FDA is issuing this alert to update healthcare professionals about changes that were made to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information for micro-bubble contrast agents in May and June 2008. These agents include Definity (perflutren lipid microsphere) Injectable Suspension and Optison (perflutren protein-type A microspheres for injection). The revised labeling changes include:
- Boxed Warning and Warnings specifically recommend intensive monitoring for patients with pulmonary hypertension or unstable cardiopulmonary conditions and close observation of patients without these underlying conditions.
- Boxed Warning identifies a risk for serious cardiopulmonary reactions.
- Warnings section also identifies a risk for serious cardiopulmonary reactions that have occurred during or within 30 minutes following administration of the products. Patients with pulmonary hypertension or unstable cardiopulmonary conditions should be monitored with vital sign measurements, electrocardiography and cutaneous oxygen saturation during and for at least 30 minutes after administration of the products. All other patients should be observed closely during and following administration of the products. Resuscitation equipment and trained personnel should always be readily available during the drug administration and monitoring period.
- Contraindications currently state that the products are contraindicated among patients with either known hypersensitivity to the products or have fixed right-to-left, bi-directional cardiac shunts or transient right-to-left shunts. The Contraindications section also notes that the products are not for intra-arterial injection.
The following Contraindications were removed from the labeling:
- Worsening or clinically unstable congestive heart failure.
- Acute myocardial infarction or acute coronary syndromes.
- Serious ventricular arrhythmias or high risk for arrhythmias due to prolongation of the QT interval.
- Respiratory failure.
- Severe emphysema.
- Pulmonary emboli or other conditions that cause pulmonary hypertension.
This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this when additional information or analyses become available.