Friday, June 13, 2008

FDA Removes Black Box Warning

The FDA has removed the black box warning on DEFINITY, an ultrasound contrast agent used in the USA to enhance echocardiograms. HURRAH!

According to an on-line press release on the web site for Lantheus Medical Imaging, Inc., the United States Food and Drug Administration has agreed to allow important changes to the product labeling for ultrasound contrast agents (UCAs). Lantheus Medical Imaging markets the UCA DEFINITY®. In October of 2007 the FDA mandated that Definity and other UCAs carry a “black box warning” as a result of complications in some patients (see previous report ). The 2007 warning required monitoring of all patients who received contrast injections. Many members of the ultrasound community, particularly those in the echocardiography community, felt that the FDA’s labeling requirement was unwarranted and would adversely impact patient care. Now, based on safety information provided to the FDA by both Lantheus and members of the medical community, the boxed WARNING and WARNINGS sections of the Package Inserts have been revised, most notably to require monitoring of only patients with pulmonary hypertension or unstable cardiopulmonary conditions. Similar label updates have been approved by the FDA for all perflutren-containing microsphere contrast agents. Lantheus Medical Imaging will host a webcast for healthcare providers to provide an overview of the new Package Insert. For information on the webcast call 1-800-343-7851.

Peace, Gizz