Imaging Agent Linked to 4 Deaths
Since October, four patients have died within two hours after receiving the Definity imaging agent, which is used to enhance ultrasound images, according to an FDA document reported on by Bloomberg News.
June 23, 2008
A fifth patient suffered cardiac arrest but was revived after receiving Definity, which is made by Lantheus Medical Imaging, a unit of Avista Capital Partners.Warnings for Definity and a competitor, GE's Optison, have been strengthened, and an FDA advisory panel is meeting tomorrow to further discuss safety issues associated with contrast agents. Lantheus will present a paper to the panel claiming that there is no difference between patients who received Definity and patients who received no contrast agent at all. The agency has not made any conclusions regarding the safety of Definity. A paper presented at the American College of Cardiology meeting in March argued that warnings for Definity and Optison may do more harm than good, as they could lead to less use of contrast agents, whose benefits outweigh their risks.
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