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Concerns remain over heart imaging agents: US FDA

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US health regulators remain concerned about the safety of contrast agents used to enhance echocardiogram heart imaging tests, according to Food and Drug Administration documents released on Friday.

The products - which include Optison, made by General Electric Co's GE Healthcare, and Definity, made by privately-held Lantheus Medical Imaging - have already been linked to serious heart problems and deaths in some patients. Four more deaths in patients given the Lantheus product have been reported to the agency since October 2007, according to the documents.

"FDA remains concerned about the accumulating safety data pertaining to marketed ultrasound contrast agents, and the labels for these products continue to contain a boxed warning that highlights the risk for serious cardiopulmonary reactions," agency officials wrote.

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