Perflutren (Definity) Safety Information Update

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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). </p>
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<p>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.</p>
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<p>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®.</p>
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<p>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.</p>
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<p><strong>Actions that Healthcare professionals should follow:</strong></p>
<p>· Serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes following DEFINITY® administration. </p>
<p>· Patients should be assessed for the presence of any condition that precludes DEFINITY® administration as follows;</p>
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<li>Worsening or clinically unstable congestive heart failure,
</li><li>Acute myocardial infarction or acute coronary syndromes,
</li><li>Serious ventricular arrhythmias or high risk for arrhythmias,
</li><li>Respiratory failure,
</li><li>Severe emphysema, pulmonary emboli or other conditions that cause pulmonary hypertension. </li></ul>
<p>· 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. </p>
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<p><strong>Report Adverse Drug Reactions to the Saudi FDA</strong></p>
<p>The public and health professionals are encouraged to report adverse drug</p>
<p>reactions the National Pharmacovigilance Center on the Internet at</p>
<p>http://www.sfda.gov.sa/En/Drug/Topics/Pharmacovigilance_Center.htm</p&gt;