THURSDAY, Nov. 29 (HealthDay News) -- The decision by the U.S. Food and Drug Administration to attach a 'black box' warning to ultrasound contrast agents containing perflutren has been criticized for being made without taking all the facts into account, in a report published in the Dec. 18/25 issue of the Journal of the American College of Cardiology.
Michael L. Main, M.D., of the Mid America Heart Institute in Kansas City, Mo., and colleagues write that the FDA warning contraindicates the use of these agents in patients with acute coronary syndromes, acute myocardial infarction and worsening or clinically unstable heart failure. However, this warning does not take into account the agents' proven efficacy and safety record, the authors note. The decision also fails to take into account the confounding effect of pseudocomplication and the potential risks entailed in using alternative procedures.
The researchers recommend that the FDA Medical Imaging Division convene an expert panel of cardiologists with experience in a range of imaging techniques to re-assess adverse effects attributed to perflutren-containing agents.
The authors also recommend 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."
Main and colleagues have disclosed financial relationships with POINT Biomedical, Acusphere, Inc., Bristol-Myers Squibb Medical Imaging, Medtronic and Guidant.
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