Health Canada
www.hc-sc.gc.ca
Common menu bar links
Institutional links
Sprycel (dasatinib) - Safety Information Regarding Pulmonary Arterial Hypertension (PAH) - For Health Professionals
Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
(PDF Version - 54 K)Contact: Marketed Health Products Directorate
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.
Health Canada Endorsed Important Safety Information on SPRYCEL (dasatinib) and Pulmonary Arterial Hypertension (PAH)
August 26, 2011
Subject: Pulmonary Arterial Hypertension (PAH) reported with SPRYCEL* (dasatinib)
Dear Health Care Professional,
Bristol-Myers Squibb Canada (BMS), in collaboration with Health Canada, would like to inform you of important new safety information regarding reports of serious pulmonary arterial hypertension (PAH) in patients treated with SPRYCEL* (dasatinib).
SPRYCEL* (dasatinib) belongs to the pharmacological class of protein-tyrosine kinase inhibitors. It has received marketing authorization (with conditions) for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. SPRYCEL* (dasatinib) has also received marketing authorization for the treatment of adult patients with Ph+ chronic, accelerated, or blast phase CML and adult patients with Ph+ acute lymphoblastic leukemia (ALL) who are resistant or intolerant to previous therapies.
- A total of 60 serious pulmonary hypertension (PH) cases have been reported worldwide, between June 2006 and June 2011, including 12 cases of pulmonary arterial hypertension (PAH) confirmed by right heart catheterization, in association with SPRYCEL* treatment. No Canadian cases of PH or PAH have been reported during this time period.
- Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease before initiating SPRYCEL* therapy.
- Patients who develop symptoms suggestive of PAH such as dyspnea and fatigue after initiation of treatment with SPRYCEL* should be evaluated for more common etiologies and treatment should be withheld during evaluation, if symptoms are severe.
- The diagnosis of PAH should be considered if no alternative diagnosis can be found.
- Improvements in hemodynamic and clinical parameters have been observed in patients with PAH following cessation of SPRYCEL* therapy.
- SPRYCEL* should be permanently discontinued if the diagnosis of PAH is confirmed.
Pulmonary Arterial Hypertension (PAH), a subtype of PH, is a rare, severe and progressive disease with no apparent cause, characterized by vascular proliferation and remodelling of the small pulmonary arteries, leading to increased pulmonary artery pressure and vascular resistance. PAH is diagnosed by right heart catheterization and defined by haemodynamic criteria including a mean pulmonary arterial pressure of 25 mmHg or higher and pulmonary capillary wedge pressure of 15 mmHg or lower (pre-capillary PH in the absence of post-capillary PH).
A review of the reports submitted between June 2006 and June 2011 to the Bristol-Myers Squibb global pharmacovigilance database identified a total of 60 cases of PH reported by healthcare professionals. Of these 60 cases, 36 cases were reported as pulmonary hypertension and 24 cases as pulmonary arterial hypertension (PAH) including a subset of 12 cases of PAH confirmed by right-heart catheterization. None of these cases were from Canada. Based on the total sales volume for the same period, the cumulative worldwide exposure to SPRYCEL* (dasatinib) is estimated to be 32, 882 patients.
Some patients diagnosed with PAH during SPRYCEL* (dasatinib) therapy were taking concomitant medications or had co-morbidities in addition to the underlying malignancy.
The Canadian Product Monograph for SPRYCEL* (dasatinib) has recently been revised to include this important new safety finding. A copy of most up-to-date Product Monograph can be found at: http://webprod3.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp
It is recommended that healthcare professionals follow current clinical guidelines for the diagnosis and management of patients with signs and symptoms suggestive of PAH.
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. 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. Any case of PH or PAH and other serious or unexpected adverse reactions in patients receiving SPRYCEL* (dasatinib) should be reported to BMS Canada or Health Canada at the following addresses:
Bristol-Myers Squibb Canada
2344 Alfred-Nobel, suite 300
Montreal, Canada
H4S 0A4
Telephone: 866-463-6267
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
- Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario K1A 0K9
- Canada Vigilance Program
The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffectTM Canada Web site in the Adverse Reaction Reporting section. The Reporting Form is also in the Canadian Compendium of Pharmaceuticals and Specialties.
For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738
Should you have any medical enquiries regarding SPRYCEL* (dasatinib), please contact our Medical Information Department at 866-463-6267.
Sincerely,
original signed by
H. Mitchell Shulman, MDCM, FRCPC, CSPQ
Vice-President, Medical
* TM of Bristol-Myers Squibb Company used under licence by Bristol-Myers Squibb Canada
