Sprycel (dasatinib) - Safety Information Regarding Pulmonary Arterial Hypertension (PAH) - For the Public

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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.

PUBLIC COMMUNICATION
Health Canada Endorsed Important Safety Information on SPRYCEL (dasatinib) and Pulmonary Arterial Hypertension (PAH)

August 30, 2011

Subject: Pulmonary Arterial Hypertension reported with SPRYCEL^* (dasatinib)

Bristol-Myers Squibb Canada (BMS), in collaboration with Health Canada, would like to inform patients and healthcare professionals of important new safety information regarding reports of serious pulmonary arterial hypertension (PAH) in patients treated with SPRYCEL^* (dasatinib).

SPRYCEL^* (dasatinib) is used to treat adult patients with a particular form (Philadelphia chromosome positive or Ph +) of newly diagnosed chronic myeloid leukemia (CML). It is also used to treat adult patients who have the same condition or acute lymphoblastic leukemia (ALL) showing resistance or intolerance to previous therapies.

Pulmonary hypertension (PH) is an increased blood pressure in the pulmonary arteries. These arteries carry blood from the heart to the lungs to pick up oxygen. Pulmonary Arterial Hypertension (PAH), a subtype of pulmonary hypertension, is a rare, severe and progressive disease with no apparent cause.

Pulmonary arterial hypertension (PAH) can lead to severe fluid retention in the body, shock and even death. It is important that patients recognize the following signs and symptoms of PAH while receiving SPRYCEL^* (dasatinib): shortness of breath during routine activity, tiredness, chest pain, racing heartbeat, pain on the upper right side of the abdomen, swelling or weight gain. Patients should contact their healthcare professional, if they experience any of these signs and symptoms.

BMS Canada has worked with Health Canada to include the new safety information regarding SPRYCEL^* (dasatinib) associated with PH or PAH into the Canadian Product Monograph (CPM), the reference document that healthcare professionals use when prescribing a drug, and the Consumer Information Leaflet (CIL). These documents can be found by contacting  Bristol-Myers Squibb Canada, at 1-866-463-6267.

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 drug reactions in patients receiving SPRYCEL^* (dasatinib) should be reported to BMS Canada or Health Canada at the following addresses:

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