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Date: 2008-05-28
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BMORS
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 Medical Imaging. |
| Health Canada Endorsed Important Safety Information on DEFINITY (Perflutren Injectable Suspension) |
May 23, 2008
| Subject: | Updated safety information on DEFINITY (Perflutren Injectable Suspension) and serious adverse cardiopulmonary reactions |
Dear Health Care Professional,
Bristol-Myers Squibb Medical Imaging, in consultation with Health Canada, is writing to inform you of important changes to the safety information for DEFINITY (Perflutren Injectable Suspension).
DEFINITY is an ultrasound contrast agent 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, including fatalities, have occurred worldwide in patients during DEFINITY administration, within 30 minutes of and up to several days after DEFINITY administration. As of March 31, 2008, there has been one Canadian case of a fatal cardiopulmonary adverse reaction following administration of DEFINITY.
Diagnostic procedures that involve the use of DEFINITY should be carried out under the direction of a physician with appropriate training and thorough knowledge of the procedure to be performed.
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Based on the results of the assessment of data submitted by Bristol-Myers Squibb Medical Imaging and subsequent discussions with experts in the field, the Product Monograph for DEFINITY is being updated to include the following information.
Boxed WARNING
A boxed warning will be added to the Product Monograph with respect to serious cardiopulmonary reactions, including fatalities that have occurred during or within 30 minutes of the administration of DEFINITY. This section will address the need to evaluate patients for the presence of any condition that may contra-indicate the use of DEFINITY, the close monitoring required for patients with pulmonary hypertension or unstable cardiopulmonary conditions and the necessity to have resuscitation equipment and trained personnel readily available when administering DEFINITY.
Revised WARNINGS
The Warning section will be revised to reflect the need for close monitoring in patients with pulmonary hypertension or unstable cardiopulmonary conditions, as follows:
“Serious cardiopulmonary reactions, including fatalities, have occurred during or following DEFINITY administration. The risk for these reactions may be increased among patients with pulmonary hypertension or unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias or respiratory failure, including patients receiving mechanical ventilation). In these patients, monitor vital signs, electrocardiography, and cutaneous oxygen saturation during and for at least 30 minutes after DEFINITY administration.
DEFINITY should only be administered to such patients after a careful risk/benefit assessment. Patients undergoing abdominal imaging that have serious underlying cardiovascular and respiratory co-morbidities as described above should also be monitored for 30 minutes after DEFINITY.
In the absence of these underlying conditions, observe patients closely during and following DEFINITY administration for at least 30 minutes for potential serious reactions.”
Post-market Adverse Drug Reactions
The revised Product Monograph will state that: ” In postmarketing use, fatal cardiac arrests and other serious but non-fatal adverse reactions were uncommonly reported, including loss of consciousness, convulsions, symptomatic arrhythimias (atrial fibrillation, supraventricular tachycardia, ventricular tachycardia or fibrillation), hypotension, respiratory distress, decreased oxygenation or cardiac ischemia (see ADVERSE REACTIONS and WARNINGS).”
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 email: 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 Timothy F. Nason, PhD |
original signed by Mark Hibberd, M.D. |
