Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection)

FDA ALERT [10/2007, updated 7/17/2008] - 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. The revised Boxed Warning and Warnings continue to highlight the risk of serious cardiopulmonary reactions during or within 30 minutes following the administration of these products and recommend that high risk patients with pulmonary hypertension or unstable cardiopulmonary conditions be closely monitored during and for at least 30 minutes post administration of these contrast agents. Concurrent with these labeling changes, FDA required that manufacturers of micro-bubble contrast agents conduct clinical studies to more thoroughly assess the risks for serious cardiopulmonary reactions.

Several of the Contraindications that were added to the labeling in October, 2007 were removed because FDA determined that, in some patients, the benefits from the diagnostic information that could be obtained through the use of Definity or Optison may outweigh the risk for serious cardiopulmonary reactions, even among some patients at particularly high risk for these reactions. The Contraindications that were removed include: worsening or clinically unstable congestive heart failure, acute myocardial infarction or acute coronary syndromes, serious ventricular arrhythmias or high risk of arrhythmias due to prolongation of the QT interval, respiratory failure, severe emphysema, pulmonary emboli or other conditions that cause pulmonary hypertension.

These changes reflect conclusions of FDA reviews related to information received following the addition of new contraindications and warnings to the labeling for these products in October 2007.

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.

Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.

• Healthcare Professional Information
  • Information for Healthcare Professionals
  • Labeling for Definity from Drugs@FDA
  • Labeling for Optison from Drugs@FDA