The Federal Drug Administration (FDA) Safety Information and Adverse Event Reporting Program is reporting a new concern with the drug, Sprycel (dasatinib). The FDA is notifying healthcare professionals that Sprycel may increase the risk of a rare but serious condition in which there is abnormally high blood pressure in the arteries of the lungs (pulmonary arterial hypertension [PAH]). Symptoms of PAH may include shortness of breath, fatigue, and swelling of the body in areas such as the ankles and legs.
According to the reported cases, patients developed PAH after starting Sprycel, including after more than one year of treatment. Information about this risk has been added to the Warnings and Precautions section of the Sprycel drug label.
Sprycel (dasatinib) is being used to treat certain adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL).
The FDA is recommending that healthcare professionals 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.