Revised labels for contrast agents due to deaths.FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. has received reports of deaths and serious cardiopulmonary reactions following the administration of ultrasound micro-bubble contrast agents used in echocardiography Echocardiography Definition Echocardiography is a diagnostic test that uses ultrasound waves to create an image of the heart muscle. Ultrasound waves that rebound or echo off the heart can show the size, shape, and movement of the heart's valves and , the agency stated in a release Oct. 12. Four of the 11 reported deaths were caused by cardiac arrest cardiac arrest n. Abbr. CA A sudden cessation of cardiac function, resulting in loss of effective circulation. Cardiac arrest A condition in which the heart stops functioning. 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 acute myocardial infarction (  ·kyōōtˑ mī·ō·karˑ·dē· ,
respiratory failure, or recent worsening congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. .
Read the complete MedWatch 2007 Safety Summary, including a link to the Drug Information Page, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#bubble |
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