Carson et al., "The safety of definity and optison
for ultrasound image enhancement: a retrospective analysis of 78,383 administered contrast doses," Journal of the American Society of Echocardiography, vol.
Examination of inertial cavitation of Optison
in producing sonoporation of chinese hamster ovary cells.
Although agents have been approved for many years in Europe, they have been less well received in USA, and in October 2007 the FDA issued a requested that a boxed warning be added to the labeling of Definity and Optison
, following reports of deaths and some serious cardiopulmonary reactions after administration of the agents in echocardiography.
Two ultrasound contrast agents, Definity (Bristol-Meyers Squibb) and Optison (GE Healthcare), are approved in the United States for use to improve suboptimal echocardiograms.
In issuing the warning, the FDA said it had received reports of serious cardiopulmonary reactions following contrast injection, including 10 deaths after the administration of Definity and 1 death after an Optison injection.
The manufacturers of Definity (perflutren lipid microsphere) injectable suspension and Optison (perflutren protein-type A microspheres for Injection), the only microbubble ultrasound contrast agents approved in the United States, have agreed to add a black box warning and other warnings to the product labels describing these risks.
There have been 10 postmarketing deaths reported with Definity and 1 following the administration of Optison, which was approved in 1997; marketing of Optison was temporarily suspended in 2005.
Recently, commercially available ultrasound contrast agents (UCAs) such as SonoVue and Optison
are widely used for ultrasound imaging, because they enhance the blood pool signal due to their large particle size (2-8 [micro]m).
Studies should focus on the two contrast agents most commonly used in adults, Optison
(perflutren protein-type A microspheres) and Definity (perflutren lipid microspheres), Dr.
For example, after passage through the heart, Albunex lasts for only 15-30 seconds, and Optison
for about 2 minutes.