Barnes-Jewish drops echo contrast before FDA alert

October 15, 2007

The Cardiac Diagnostic Laboratory at Barnes-Jewish Hospital in St. Louis has stopped using Definity, the echocardiographic contrast agent marketed by Bristol-Myers Squibb, according to an Oct. 11 memo obtained by Diagnostic Imaging.

The Cardiac Diagnostic Laboratory at Barnes-Jewish Hospital in St. Louis has stopped using Definity, the echocardiographic contrast agent marketed by Bristol-Myers Squibb, according to an Oct. 11 memo obtained by Diagnostic Imaging. The policy change at the hospital, affiliated with the Mallinckrodt Institute of Radiology and the Washington University Heart Care Institute, was issued before FDA revisions of the Definity package insert alerting practitioners to the risk of severe adverse reactions possible with the agent's use.In the Barnes-Jewish Hospital memo, Dr. Julio E. Perez, director of echocardiography, states that "effective immediately and until further notice, it is our decision that the CDL will not employ Definity for contrast enhancement in any patients, at any of our facilities, and even if requested by a physician order." Perez was not immediately available for comment.The FDA announced Oct. 12 on its website (www.fda.gov) that Bristol-Myers Squibb and GE, the makers of Definity and Optison, respectively, agreed to revisions to product labeling. The FDA had received reports of deaths and serious cardiopulmonary reaction after the administration of microbubble contrast during echocardiography. Four of the 11 reported deaths were caused by cardiac arrest either during infusion or within 30 minutes after administration of the contrast agent, according to the FDA report. The black box labeling for Definity warns of serious cardiopulmonary reactions during or within 30 minutes of its administration. Users are instructed to review the agent's contraindications and monitor patients during and for 30 minutes after administration. Vital sign measurement and electrocardiography are urged for all patients. The need for cutaneous oxygen saturation monitoring for patients at risk for hypoxemia and immediate access to resuscitation equipment was emphasized.

Contraindications for Definity were established by the FDA for the following known or suspected conditions:

  • right-to-left, bidirectional, or transient right-to-left cardiac shunts
  • worsening or clinically unstable congestive heart failure
  • acute myocardial infarction or acute coronary syndromes
  • serious ventricular arrhythmias or high risk for arrhythmias due to prolongation of the QT interval
  • respiratory failure, as manifested by signs or symptoms of carbon dioxide retention or hypoxemia
  • severe emphysema, pulmonary emboli, or other conditions that cause pulmonary hypertension due to compromised pulmonary arterial vasculature
  • hypersensitivity to perflutren

Label revisions for Optison, the only other FDA-approved ultrasound agent, are pending, though GE had stopped selling the agent several months ago.

For more information, refer to the following from Diagnostic Imaging archives:

Black box warning planned for ultrasound microbubble contrast

Journal Review: AIUM renews crusade to have contrast agents approved for use beyond the heart

Multislice CT and microbubble sonography target inflammation in the small bowel

Ultrasound's future in play: will radiologists remain in the picture?