FDA notified healthcare professionals that dasatinib (Sprycel, Bristol-Myers Squibb) may increase the risk of pulmonary arterial hypertension (PAH), a rare but serious condition in which there is abnormally high blood pressure in the arteries of the lungs.

Symptoms of PAH may include shortness of breath, fatigue and swelling of the body (such as the ankles and legs). In reported cases, patients developed PAH after starting Sprycel, including after more than one year of treatment.

Dasatinib is used to treat certain adult patients with Philadelphia chromosome-positive chronic myeloid leukemia or acute lymphoblastic leukemia.

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.