Thinking Outside the “Box”—The Ultrasound Contrast Controversy
Key result
The FDA's black box warning for perflutren-containing ultrasound contrast agents ignores their proven efficacy, established safety, and the potential risks of alternative diagnostic procedures.
Why the study?
Should perflutren-containing ultrasound contrast agents be contraindicated in patients with acute coronary syndromes, myocardial infarction, and unstable heart failure?
Structured PICO
Should perflutren-containing ultrasound contrast agents be contraindicated in patients with acute coronary syndromes, myocardial infarction, and unstable heart failure?
P
Population
Patients with acute coronary syndromes, acute myocardial infarction, and worsening or clinically unstable heart failure
I
Intervention
Perflutren-containing ultrasound contrast agents
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Although appearing prudent at face value, especially in light of the recent intense focus on patient safety, these strident warnings ignore the proven efficacy of ultrasound contrast agents, the previously established safety of these compounds, the potential risks of alternative procedures, and the likely confounding effect of pseudocomplication.”
“It has been pointed out ([Grayburn 2008, Main et al 2007]) that the FDA has responsibility for product safety, but that this is not necessarily the same as patient safety. Patient safety remains the responsibility of the clinician.”
Implication
The authors argue that the FDA's black box warning for perflutren-containing ultrasound contrast agents ignores their proven efficacy and the potential risks of alternative diagnostic procedures.
Abstract
On October 10, 2007, the U.S. Food and Drug Administration (FDA) announced a new "black box" warning for the perflutren-containing ultrasound contrast agents, contraindicating their use in patients with acute coronary syndromes, acute myocardial infarction, and worsening or clinically unstable heart failure. These warnings ignore the proven efficacy of ultrasound contrast agents, the previously established safety of these compounds, the potential risks of alternative procedures, and the likely confounding effect of pseudocomplication. We suggest that the FDA Medical Imaging Division convene a panel of cardiologists experienced in a variety of imaging modalities to fully assess the adverse events that have been attributed to these agents and that any future FDA warnings acknowledge the possible influence of pseudocomplication, the proven efficacy of the modality in question for early and accurate diagnosis of cardiovascular disease, and the known and theoretical risks of alternative testing that may be necessary.
Discussion
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Cite This Study
Main et al. (2007) conducted an editorial in Acute coronary syndromes, acute myocardial infarction, and worsening or clinically unstable heart failure. Perflutren-containing ultrasound contrast agents was evaluated. The FDA's black box warning for perflutren-containing ultrasound contrast agents ignores their proven efficacy, established safety, and the potential risks of alternative diagnostic procedures.