To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Important Safety Information Released on Definity(R) (Perflutren Injectable Suspension) and Serious Cardiopulmonary Reactions URL: http://www.pslgroup.com/dg/21604A.htm Doctor's Guide October 19, 2007
OTTAWA, CANADA -- October 19, 2007 -- Bristol-Myers Squibb Medical Imaging has sent a letter to health care professionals to inform them of important updated safety information regarding Definity(R) (Perflutren Injectable Suspension), pertaining to serious cardiopulmonary reactions, including fatalities, associated with the use of Definity(R). Definity(R) 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. Serious cardiopulmonary reactions have been reported in association with Definity(R) 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, with none reported from Canada. In post-marketing use, four patients experienced fatal cardiac arrests either during or within 30 minutes of Definity(R) administration. It should be noted that prior to the administration of Definity(R), 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(R) was administered and the patient underwent a cardiac stress test. Other uncommon but serious reactions observed during or shortly following Definity(R) 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. In light of these important safety data Bristol-Myers Squibb Medical Imaging is working with Health Canada toward revising the Product Monograph for Definity(R). As an interim measure, physicians are notified of the following updated safety information. Advice to physicians regarding serious cardiopulmonary reactions with Definity(R) · Serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes following Definity(R) administration. · Patients should be assessed for the presence of any condition that precludes Definity(R) administration (see below). · Patients should be monitored during and for 30 minutes following Definity(R) 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(R) administration. Conditions that preclude the administration of Definity(R) include: · Worsening or clinically unstable congestive heart failure, · Acute myocardial infarction or acute coronary syndromes, · Serious ventricular arrhythmias or high risk for arrhythmias, · Respiratory failure, · Severe emphysema, pulmonary emboli or other conditions that cause pulmonary hypertension. · In addition, caution should be used with respect to the administration of Definity(R) with exercise stress or pharmacologic stress agents (e.g. I.V. dipyridamole). Bristol-Myers Squibb Medical Imaging remains committed to providing you the most current and accurate information available for our products. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. The identification, characterization and management of marketed health product-related adverse reactions are dependent on the active participation of health care professionals in adverse reaction reporting programs. Any occurrences of hypersensitivity or other serious or unexpected adverse reactions in patients receiving Definity(R) should be reported to Bristol-Myers Squibb Medical Imaging or Health Canada at the following addresses: Bristol-Myers Squibb Canada 2365 Côte-de-Liesse Montréal, Québec H4N 2M7 Tel : 866-463-6267 Any suspected adverse reaction can also be reported to: Canada Vigilance Program Marketed Health Products Directorate HEALTH CANADA Address Locator: 0701C OTTAWA, Ontario, K1A 0K9 Tel: 613-957-0337 or Fax: 613-957-0335 To report an Adverse Reaction, consumers and health professionals may call toll free: Tel: 866-234-2345 Fax: 866-678-6789 CanadaVigilance@hc-sc.gc.ca SOURCE: Health Canada --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.