FDA formally updates echo contrast black box warning

Jul 17, 2008

The U.S. Food and Drug Administration (FDA) has formally released changes first announced in May and June to the black box warning labeling of echocardiography contrast agents.

In a July 17 alert, the FDA sought to update healthcare professionals about the modifications, which removed a number of contraindications from the Boxed Warnings, Warnings, and Contraindications sections of the prescribing information for the Definity (Lantheus Medical Imaging, North Billerica, MA) and Optison (GE Healthcare, Chalfont St. Giles, U.K.) microbubble contrast agents.

The agency said the warnings continue to highlight the risk of serious cardiopulmonary reactions during or within 30 minutes of administration of these contrast agents, and recommend that high-risk patients with pulmonary hypertension or unstable cardiopulmonary conditions be closely monitored during administration and for at least 30 minutes postadministration.

The FDA said it chose to remove several contraindications because it determined that for some patients, the benefits of the diagnostic information that could be obtained through the use of Definity or Optison may outweigh the risk of serious cardiopulmonary reactions.

The following contraindications were removed:

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
Pulmonary emboli or other conditions that cause pulmonary hypertension

The FDA has required the contrast agent manufacturers to conduct clinical studies to more thoroughly assess the risk for severe cardiopulmonary reactions.

More study of heart imaging agent risks urged, June 25, 2008

Concerns remain over heart imaging agents: U.S. FDA, June 20, 2008

GE revises Optison's prescribing information, June 11, 2008

ASE welcomes echo contrast labeling change, May 22, 2008