FDA to Warn Doctors About Problems with Imaging AgentsFDA to Warn Doctors About Problems with Imaging Agents
FDA said it will alert doctors to problems associated with two imaging agents that are injected into patients' veins before their hearts are viewed via echocardiography, an ultrasound procedure, Reuters reports. The agency is investigating reports that GE's Optison and Bristol-Myers Squibb's Definity are associated with deaths and severe cardiopulmonary reactions. It is possible the products will be required to carry a "black box" warning, the strongest kind.
October 9, 2007
1 Min Read
Definity is currently on the market; Optison was recalled in 2005 because of manufacturing issues and is scheduled for relaunch soon. Only a small percentage of patients who receive echocardiograms are injected with either product.
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