FDA warning flummoxes ultrasound contrast trial

January 22, 2008 FDA warning flummoxes ultrasound contrast trial Notice catches AIUM off guard as both parties had agreed about noncardiac use of microbubble agents James Brice -------------------------------------------------------------------------------- Plans for a clinical trial designed to overcome long-standing regulatory obstacles to the general clinical use of ultrasound contrast media in the U.S. have been knocked off track by an FDA-mandated black box safety warning for two microbubble agents approved for echocardiography. The black box warning for Bristol-Myers Squibb's Definity and GE Healthcare's Optison agents-issued Oct. 15-emphasizes the risk of serious cardiopulmonary reactions. FDA representatives in 2006 had expressed general support for a draft plan from the American Institute of Ultrasound in Medicine for a clinical trial testing the efficacy of microbubble contrast for imaging transarterial chemoembolism of liver lesions. FDA officials suggested that the AIUM group use an approved cardiac agent (Definity or Optison) in its trial, according to Dr. Lennard Greenbaum, immediate past president of the AIUM.

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