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|
 micro-bubble contrast agents |
| Definity, Optison |
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Pharmaceutical
company:
Bristol-Myers Squibb Co.
www.bms.com |
NEW WARNING
The FDA has issued an alert regarding reported deaths and serious cardiopulmonary reactions following the administration of ultrasound micro-bubble contrast agents (Definity, Optison) used in echocardiography. Four of 11 reported deaths occurred during the procedure or within 30 minutes of the infusion. The FDA has asked that a Black Box warning be added to the prescribing information for these drugs as well as other warnings regarding the risk of serious cardiovascular reactions. They recommend that all patients be assessed for serious cardiac disease, arrhythmias, emphysema, congenital heart defects, or previous serious reaction to any drug given during an echocardiogram. The boxed warning will indicate the need for constant monitoring of heart rhythm, oxygen saturation, and vital signs during the procedure and that emergency equipment should be readily available.
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