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

November 1, 2007

Audience: Radiologists, radiology technicians, cardiologists, other healthcare professionals

[Posted 10/12/2007] FDA has received reports of deaths and serious cardiopulmonary reactions following the administration of ultrasound micro-bubble contrast agents used in echocardiography. Four of the 11 reported deaths were caused by cardiac arrest occurring either during infusion or within 30 minutes following the administration of the contrast agent; most of the serious but non-fatal reactions also occurred in this time frame. As a result, the manufacturers of Definity and Optison have agreed to revise the labeling for these products in order to optimize their safe use.

Revised labeling includes changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, and a statement in the INDICATIONS section cautioning that the safety and efficacy of the use of Definity with exercise or pharmacological stress testing have not been established. Together these labeling changes emphasize the risk for serious cardiopulmonary reactions, and that the use of these products is contraindicated in patients with unstable cardiopulmonary status, including patients with unstable angina, acute myocardial infarction, respiratory failure, or recent worsening congestive heart failure.

[October 12, 2007 - Information for Healthcare Professionals - FDA]

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