The FDA has updated its boxed warning, warnings and contraindications sections of the prescribing information for micro-bubble contrast agents to highlight the risk of serious cardiopulmonary reactions within 30 minutes following the administration of the products.
The agency is recommending that high-risk patients with pulmonary hypertension or unstable cardiopulmonary conditions be closely monitored during and for at least 30 minutes after the administration of an agent.
Concurrent with the labeling changes, the FDA is requiring that the manufacturers of micro-bubble contrast agents—GE Healthcare and Lantheus Medical Imaging—to conduct clinical studies to “more thoroughly assess the risks for serious cardiopulmonary reactions.”
The changes reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007.
In addition, several of the contraindications that were added to the labeling in October 2007 were removed in June because it determined that, in some patients, the benefits from the diagnostic information obtained through the use of Definity or Optison may outweigh the risk for serious cardiopulmonary reactions, even among some patients at particularly high risk for the reactions.