Health Canada Warns of PAH Associated with Sprycel

Health Canada, collaborating with drug maker Bristol-Myers Squibb Canada (BMS), just issued a warning concerning serious pulmonary arterial hypertension (PAH) linked to <"">Sprycel (dasatinib).

Sprycel is part of the drug class of protein-tyrosine kinase inhibitors medications and has received marketing authorization, with conditions, for the treatment of adults with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase. Sprycel is also authorized for the treatment of adults with Ph+ chronic, accelerated, or blast phase CML and adult patients with Ph+ acute lymphoblastic leukemia (all) who are resistant or intolerant to other, prior therapies.

According to Health Canada, 60 serious pulmonary hypertension (PH) cases have been reported worldwide from June 2006 through June 2011. This includes 36 cases of PH and 24 cases of PAH; 12 PAH cases were confirmed by right heart catheterization and have been linked to treatment with Sprycel. Health Canada noted that based on total sales during this period, the total global exposure to Sprycel is 32,882 patients.

Health Canada advises that patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease before receiving treatment with Sprycel. Patients who develop symptoms consistent with PAH, such as dyspnea and fatigue after starting Sprycel treatment should be evaluated for more common medical conditions; treatment should be withheld during evaluation if symptoms are severe. A PAH diagnosis should be considered if no alternative is found.

Hemodynamic improvements and improvements in other clinical parameters have been seen in patients with PAH after Sprycel therapy was stopped. Health Canada warned that Sprycel therapy should be permanently discontinued if a PAH diagnosis is confirmed.

PAH is a subtype of PH, which is a rare, severe, and progressive disease with no apparent cause. The disease is characterized by vascular proliferation and remodeling of the small pulmonary arteries. This leads to increased pulmonary artery pressure and vascular resistance. Diagnosis is made by right heart catheterization and defined by haemodynamic criteria, which includes 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), explained Health Canada.

It is recommended that healthcare professionals follow current clinical guidelines for the diagnosis and management of patients with signs and symptoms suggestive of PAH.

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