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.
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 www.healthcanada.gc.ca/medeffect or by calling toll-free 1-866-234-2345.
?? The Canadian Press, 2011