At the behest of the U.S. Food and Drug Administration (FDA), Bristol-Myers Squibb Medical Imaging division of North Billerica, MA, will add a warning label to its echocardiography contrast agent Definity.
The FDA's October 10 notice warns that "serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes following Definity administration." Potential adverse effects include loss of consciousness and convulsions.
The agency advises doctors to assess all patients for the presence of any condition that precludes Definity administration, and monitor patients during and for 30 minutes following administration, including vital sign measurements and an electrocardiogram (ECG) in all patients and cutaneous oxygen saturation in patients at risk for hypoxemia.
Definity is indicated for use in patients with suboptimal ECGs to opacify the left ventricular chamber and to improve delineation of the left ventricular endocardial border.
The FDA on October 8 said it would require black box warnings for Definity and one other cardiac ultrasound contrast agent marketed in the U.S., Optison from GE Healthcare of Chalfont St. Giles, U.K.
By AuntMinnie.com staff writers
October 12, 2007
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