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Dasatinib linked to risk for PAH
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Dasatinib may increase the risk for pulmonary arterial hypertension, the FDA warned today. In reported cases, patients developed the condition after starting dasatinib, including after more than 1 year of treatment.
Information about this risk has been added to the Warnings and Precautions section of the drug label.
Dasatinib (Sprycel, Bristol-Myers Squibb) is used to treat adults with Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL).
Symptoms of pulmonary arterial hypertension (PAH) may include shortness of breath, fatigue and swelling of the body, such as the ankles and legs.
According to the FDA, health care professionals should evaluate patients for signs and symptoms of underlying cardiopulmonary disease prior to starting, and during treatment with dasatinib. Treatment should be permanently discontinued if PAH is confirmed.
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