ROCKVILLE, Md -- July 17, 2008 -- The US Food and Drug Administration (FDA) issued an 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. The revisions recommend that high-risk patients with pulmonary hypertension or unstable cardiopulmonary conditions be closely monitored during and for at least 30 minutes postadministration of these contrast agents.
Concurrent with these labelling changes, the FDA required that manufacturers of micro-bubble contrast agents conduct clinical studies to more thoroughly assess the risks for serious cardiopulmonary reactions.
Several of the Contraindications that were added to the labelling in October 2007 were removed because the FDA determined that, in some patients, the benefits from the diagnostic information that could be obtained through the use of perflutren lipid microsphere (Definity) injectable suspension or perflutren protein-type A microspheres for injection (Optison) may outweigh the risk for serious cardiopulmonary reactions, even among some patients at particularly high risk for these reactions.
The Contraindications that were removed include worsening or clinically unstable congestive heart failure, acute myocardial infarction or acute coronary syndromes, serious ventricular arrhythmias or high risk of arrhythmias due to prolongation of the QT interval, respiratory failure, severe emphysema, and pulmonary emboli or other conditions that cause pulmonary hypertension.
These changes reflect conclusions of FDA reviews related to information received following the addition of new contraindications and warnings to the labelling for these products in October 2007.
SOURCE: US Food and Drug Administration
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