October 11, 2011
SAFETY ALERT: Pulmonary Arterial Hypertension Risk with SprycelThe FDA has notified healthcare professionals that Sprycel (dasatinib; Bristol-Myers Squibb) may increase the risk of pulmonary arterial hypertension (PAH). Twelve cases of PAH from the manufacturer's database were confirmed by right heart catheterization, and Sprycel was identified as the most likely cause. In these cases, symptoms were reported and PAH diagnosed after Sprycel initiation. Patients developed PAH after receiving Sprycel therapy for various time intervals, including more than one year. Patients diagnosed with PAH during Sprycel therapy were often taking concomitant medications or had co-morbidities. 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.
Information about this risk has been added to the Warnings and Precautions section of the Sprycel labeling. Healthcare professionals should evaluate patients for signs and symptoms of underlying cardiopulmonary disease prior to starting Sprycel and also during treatment. If PAH is confirmed, Sprycel should be permanently discontinued.
Sprycel is indicated for the treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase; chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib; and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
For more information visit www.fda.gov/Drugs/DrugSafety/ucm275155.htm.