FDA announces pulmonary issue associated with Sprycel

The US FDA has announced that the leukemia therapeutic drug Sprycel (dasatinib) presents patients with the risk of developing pulmonary arterial hypertension (PAH), a type of high blood pressure that affects arteries in the lung and on the right-hand side of the heart. It is typically a progressive disease that can in time be fatal.

Sprycel is an oral tyrosine kinase inhibitor first approved by the FDA in 2006 for treatment of chronic myelogenous leukemia after failure of imatinib treatment and in patients with Philadelphia positive acute lymphoblastic leukemia.

The agency is telling physicians that they should examine their patients for any signs or symptoms that might suggest an underlying cardiopulmonary disease prior to prescribing Sprycel. Furthermore, all patients should be evaluated during Sprycel treatment for any evidence of PAH developing.

If doctors suspect Sprycel-associated PAH, Sprycel should be discontinued immediately. Fortunately, in these cases it's believed that the PAH is reversible if caught in time.

The agency announcement is coming on the heels of 12 reported cases of PAH with Sprycel as the most likely cause. According to the FDA, "There may be a combination of factors contributing to the development of PAH in patients taking Sprycel. In some cases, improvements in hemodynamic and clinical parameters were observed following discontinuation of Sprycel."