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.
