In October, 2007, the FDA issued a new ‘black box’ warning, several new disease
state contraindications and a mandated 30-min post-procedure monitoring
period for the ultrasound contrast agents Definity ® (perflutren lipid
microsphere injectable suspension, Lantheus Medical Imaging, North Billerica,
MA, USA) and Optison ™ (perflutren protein type A microspheres for injectable
suspension, GE Healthcare, Buckinghamshire, UK). These labeling changes
were largely secondary to reports of 4 patient deaths, and ∼ 190 other ‘serious
cardiopulmonary reactions’ that were temporally related but not clearly
causally attributable to Definity administration. Contrast agent use in the
US plummeted in the immediate aftermath of this FDA action, with many
hospitals, physician offices and outpatient imaging centers suspending
contrast echocardiography altogether. This review will focus on the immediate
response from the international physician community, new contrast agent
safety data published within the past year, results of a special meeting of
the FDA Cardio-Renal panel devoted to contrast agent safety in June 2008,
recently issued revised product labeling for both agents and future prospects
for contrast echocardiography.
Full paper available for download as a PDF here
