FDA Update on Cardiopulmonary Reactions with Ultrasound Micro-bubble Contrast Agents
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- Duration: 1:34
- Published: 2008-12-13
- Uploaded: 2010-08-03
- Author: DefendingTheConsumer
- http://wn.com/FDA_Update_on_Cardiopulmonary_Reactions_with_Ultrasound_Micro-bubble_Contrast_Agents
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FDA is alerting healthcare professionals about labeling changes for ultrasound micro-bubble contrast agents, which are sold as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection). These products are used during echocardiography to enhance a cardiac image. The revised labeling continues to highlight the risk of serious cardiopulmonary reactions, either while the contrast agent is being administered or within 30 minutes afterwards, especially in patients with pulmonary hypertension or unstable cardiopulmonary conditions. However, based on a review of published reports and information from physicians, FDA has now determined that the benefits of the diagnostic information provided by Definity or Optison may outweigh the risk of cardiopulmonary reactions, even among some high-risk patients. As a result, these products are no longer contraindicated for patients with unstable cardiopulmonary status, including those with unstable angina, acute myocardial infarction, respiratory failure, or congestive heart failure that has recently worsened. The boxed warning points out that in these high risk patients, it is important to monitor vital signs, electrocardiography and cutaneous oxygen saturation while administering the contrast agents and for at least 30 minutes afterwards.
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