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(Circulation. 2009;119:1956-1961.)
© 2009 American Heart Association, Inc.

New Drugs and Technologies

Overview of the 2008 Food and Drug Administration Advisory Committee on Safety Considerations in the Development of Ultrasound Contrast Agents

Federico M. Asch, MD; Neil J. Weissman, MD

From the Cardiovascular Research Institute/Medstar Research Institute, Washington Hospital Center, Washington, DC.

Correspondence to Neil J. Weissman, MD, Washington Hospital Center, MedStar Research Institute, 100 Irving St NW, Suite EB-5123, Washington, DC 20010. E-mail Neil.J.Weissman@medstar.net

Key Words: contrast media • echocardiography • imaging

An extract of the first 250 words of the full text is provided, because this article has no abstract.

	Introduction

 
Perflutren-based ultrasound contrast agents have been in clinical use in the United States for >10 years. Since their approval by the US Food and Drug Administration (FDA) (Optison in 1995, Definity in 2001), >2 million doses have been used for left ventricular (LV) opacification and endocardial border definition in technically difficult patients and for other off-label uses (detailed in Table 1). Despite the widespread use of contrast echocardiography, recent concerns have prompted an FDA box warning and the convening of an advisory panel. A box warning (or black box warning) is a method used by the FDA to highlight adverse reactions so serious in proportion to the potential benefit from the drug that it is essential that they be considered by the prescriber. Contraindications, warnings, or precautions can be included. Within the matter of a year, regulations on ultrasound contrast agents underwent several changes. Initially, a new box warning was required (October 2007) in response to isolated reports of serious adverse events. Then, in May 2008, after review of additional safety reports on larger cohorts of patients, the box warning was modified. At approximately the same time as the black box modification, an FDA advisory panel was organized and convened to provide guidance for the agency to delineate what further actions are necessary to further evaluate the safety of ultrasound contrast agents. This review summarizes the proceedings of the FDA advisory panel meeting, which took place on June 24, 2008, in which all of these issues were addressed.

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