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Important safety information on Definity (Perflutren Injectable Suspension) - For Health Professionals
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(PDF Version - 62 K)Contact Marketed Health Products Directorate (MHPD)
The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Bristol-Myers Squibb Canada.
Contact the company for a copy of any references, attachments or enclosures.
18 October 2007
Subject: Important safety information on DEFINITY® (Perflutren Injectable Suspension) and serious cardiopulmonary reactions
Dear Health Care Professional,
Bristol-Myers Squibb Medical Imaging is writing to inform you of important updated safety information regarding DEFINITY® (Perflutren Injectable Suspension) pertaining to serious cardiopulmonary reactions, including fatalities, associated with the use of DEFINITY®.
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.
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, with none reported from Canada. 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.
In light of these important safety data Bristol-Myers Squibb Medical Imaging is working with Health Canada toward revising the Product Monograph for DEFINITY®.
As an interim measure, physicians are notified of the following updated safety information.
Advice to physicians regarding serious cardiopulmonary reactions with DEFINITY®
- 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 (see below).
- 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.
Conditions that preclude the administration of DEFINITY® 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® 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® 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
The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.
For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: MHPD_DPSC@hc-sc.gc.ca
Tel: 613-954-6522
Fax: 613-952-7738
Your professional commitment in this regard has an important role in protecting the well-being of your patients by contributing to early signal detection and informed use of drugs.
If you require any further information on DEFINITY® (Perflutren Injectable Suspension), please contact Bristol-Myers Squibb Medical Imaging Information at 866-463-6267.
Sincerely,
original signed by
Vice-President,
Regulatory Affairs and QA
Medical Director,
Global Medical Affairs and Senior Medical Officer
