US FDA requests warnings for micro-bubble contrast agents
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US FDA requests warnings for micro-bubble contrast agents The US FDA has requested that a boxed warning, and other warnings, be added to the labelling for ultrasound micro-bubble contrast agents [Definity, Optison], following reports of deaths and serious cardiopulmonary reactions associated with such agents. The agents are indicated for use in patients with suboptimal ECGs. The FDA received postmarketing reports of 10 deaths following the administration of Definity, and one death following administration of Optison. Four of the 11 reported deaths resulted from cardiac arrest occurring either during infusion or within 30 mins after administration of the contrast agent. In addition, the agency has received approximately 190 reports of serious, nonfatal adverse reactions following the administration of Definity, and nine reports of such reactions following Optison administration. The majority of these nonfatal reactions occurred within a similar timeframe as above. Warnings emphasising the risk of serious cardiopulmonary reactions have been requested for the labelling of these products. The FDA has also asked that the agents be contraindicated in patients with unstable cardiopulmonary status. FDA. Micro-bubble contrast agents (marketed as Definity (perflutren lipid microsphere) injectable suspension and Optison (perflutren protein-type A microspheres for injection). Internet Document : [3 pages], 12 Oct 2007. Available 801052339 from: URL: http://www.fda.gov
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Reactions 20 Oct 2007 No. 1174
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