Author + information
- Received November 5, 2007
- Revision received November 12, 2007
- Accepted November 13, 2007
- Published online December 18, 2007.
- Michael L. Main, MD, FACC⁎,1,⁎ (, )
- Jonathan H. Goldman, MD, FACC†,2 and
- Paul A. Grayburn, MD, FACC‡,3
- ↵⁎Reprint requests and correspondence:
Dr. Michael L. Main, Cardiovascular Consultants, 4330 Wornall Road, Suite 2000, Kansas City, Missouri 64111.
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.
↵1 Dr. Main has received research support from and has a consultant relationship with POINT Biomedical, Acusphere, Inc., and Bristol-Myers Squibb Medical Imaging.
↵2 Dr. Goldman is a POINT Biomedical shareholder and has a consultant relationship with Bristol-Myers Squibb Medical Imaging.
↵3 Dr. Grayburn has received grant support from the National Institutes of Health, Acusphere, Inc., POINT Biomedical, Medtronic, and Guidant.
See accompanying online Cardiosource Slide Set.
- Received November 5, 2007.
- Revision received November 12, 2007.
- Accepted November 13, 2007.
- American College of Cardiology Foundation