October, 18th , 2007, Health Canada, the Canadian equivalent of the Saudi Food and Drug Authority (SFDA), announced Important Safety Information on Definity (Perflutren Injectable Suspension).
DEFINITY® is an ultrasound contrast indicated for contrast-enhanced ultrasound imaging of cardiac structures (ventricular chambers and endocardial borders) and function (regional wall motion) in adult patients with suboptimal echocardiograms. It is also indicated for contrast-enhanced ultrasound imaging of the liver and kidneys in adult patients to improve the evaluation of pathology.
Bristol-Myers Squibb Medical Imaging has sent a letter to Health Canada to inform healthcare professionals about important updated safety information regarding DEFINITY® (Perflutren Injectable Suspension) pertaining to serious cardiopulmonary reactions, including fatalities, associated with the use of DEFINITY®.
Serious cardiopulmonary reactions have been reported in association with DEFINITY® in the post-marketing setting. As of September 30 2007, a total of 99 cases of serious cardiopulmonary reactions have been reported to the company. In post-marketing use, four patients experienced fatal cardiac arrests either during or within 30 minutes of DEFINITY® administration. It should be noted that prior to the administration of DEFINITY®, 3 of the 4 patients had the following pre-existing conditions: two patients had severe congestive heart failure and one was undergoing mechanical ventilation for respiratory failure. In the remaining patient, DEFINITY® was administered and the patient underwent a cardiac stress test. Other uncommon but serious reactions observed during or shortly following DEFINITY® administration included cardiac or respiratory arrest, loss of consciousness, convulsions, symptomatic arrhythmias (atrial fibrillation, supraventricular tachycardia, and ventricular tachycardia or fibrillation), hypotension, respiratory distress or cardiac ischemia.
Actions that Healthcare professionals should follow:
·Serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes following DEFINITY® administration.
·Patients should be assessed for the presence of any condition that precludes DEFINITY® administration as follows;
Worsening or clinically unstable congestive heart failure,
Acute myocardial infarction or acute coronary syndromes,
Serious ventricular arrhythmias or high risk for arrhythmias,
Severe emphysema, pulmonary emboli or other conditions that cause pulmonary hypertension.
·Patients should be monitored during and for 30 minutes following DEFINITY® administration, including vital sign measurements and electrocardiography in all patients and cutaneous oxygen saturation in patients at risk of hypoxemia. Resuscitation equipment and trained personnel should be readily available during DEFINITY® administration.
Report Adverse Drug Reactions to the Saudi FDA
The public and health professionals are encouraged to report adverse drug
reactions the National Pharmacovigilance Center on the Internet at