08/30/2011 01:11 EDT | Updated 10/30/2011 05:12 EDT

Leukemia drug Sprycel linked to potentially fatal side-effect: Health Canada

OTTAWA - Health Canada is warning patients and health-care professionals about a potentially fatal side-effect related to the drug Sprycel taken by patients with certain forms of leukemia.

Sprycel (dasatinib), used to treat adults with chronic myeloid leukemia or acute lymphoblastic leukemia, has been linked to pulmonary arterial hypertension, a condition in which blood pressure is increased in the pulmonary arteries that carry blood from the heart to the lungs.

Pulmonary arterial hypertension, a subtype of pulmonary hypertension, is a rare, severe and progressive disease with no apparent cause. It can lead to severe fluid retention in the body, shock and even death.

Patients taking the drug should contact their doctor if they experience any of the following symptoms: 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 taking Sprycel should not stop taking the medication or lower the dosage without first discussing it with their health-care professional, said the federal department, which issued the advisory Tuesday in conjunction with the drug's maker, Bristol-Myers Squibb Canada.

Between June 2006 and June 2011, 60 cases of serious pulmonary hypertension were reported worldwide, including 12 cases of confirmed pulmonary arterial hypertension, in association with Sprycel treatment. No cases among Canadians taking the medication have been reported.

Health Canada said patients should tell their health-care professional if they have or have had any medical conditions, such as a heart problem and-or lung disease, before starting treatment with Sprycel.

Cheryl-Anne Simoneau, president and co-founder of the CML Society of Canada, said close to 4,500 Canadians have chronic myelogenous leukemia.

She was concerned that Canadian patients could be unduly alarmed by the Health Canada warning.

"The first thing that we want to make sure that everybody knows is that there were no cases reported in Canada because Canadians have access to a very high-level form of monitoring for this disease regardless of the drug they're taking," she said from Montreal.

Secondly, she noted that the cases of potentially fatal side-effects were culled from a global database of more than 30,000 patients, "so when you look at it in relative terms, the incidence is low."

Simoneau has been taking Sprycel since 2007, and said patients should always be mindful of side-effects. "But there are relative risks with every one of the drugs we take for this disease."

CML used to be a "very fatal disease," but the advent of new drugs has made a big difference, she indicated.

Any case of PH or PAH and other serious or unexpected adverse drug reactions in patients taking Sprycel should be reported to Bristol-Myers Squibb Canada by calling toll-free 866-463-6267 or by contacting Health Canada, online at or by calling toll-free 1-866-234-2345.

Note to readers: This is a corrected story. In a previous story, Simoneau mistakenly said cases were culled from a global database of more than 300,000 patients rather than 30,000.