Healthy Skepticism Library item: 12281
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Main ML, Goldman JH, Grayburn PA.
Thinking outside the 'box' - the ultrasound controversy
J Am Coll Cardiol 2007 Dec 18; 50:(25):2434-7
http://linkinghub.elsevier.com/retrieve/pii/S0735-1097(07)03575-9
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.
Keywords:
Acute Coronary Syndrome/mortality
Acute Coronary Syndrome/ultrasonography*
Adult
Aged
Cause of Death
Contrast Media/administration & dosage
Contrast Media/contraindications*
Contrast Media/toxicity
Drug Labeling*
Echocardiography*/mortality
Female
Fluorocarbons/administration & dosage
Fluorocarbons/contraindications*
Fluorocarbons/diagnostic use
Fluorocarbons/toxicity
Heart Failure/mortality
Heart Failure/ultrasonography*
Humans
Male
Microbubbles
Myocardial Infarction/mortality
Myocardial Infarction/ultrasonography*
Risk Factors
United States
United States Food and Drug Administration*
Ventricular Dysfunction, Left/mortality
Ventricular Dysfunction, Left/ultrasonography
