New Warning Added to Sprycel Label

Posted on October 17th, 2011 by

The US Food and Drug Administration (FDA) announced that Sprycel® (dasatinib) may increase the risk of a rare but serious condition known as pulmonary arterial hypertension.

Sprycel is a targeted therapy used to treat selected adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL).

Pulmonary arterial hypertension (PAH) is a condition in which there is high blood pressure in the arteries of the lungs. This causes the heart to work harder to pump blood, and over time it can weaken the heart. Symptoms of PAH include shortness of breath, fatigue, and swelling of the body (such as the ankles or legs).

Twelve cases of PAH have been confirmed among patients taking Sprycel. The timing of PAH onset varies, but the condition can occur more than a year after a patient starts taking Sprycel.

Because of the increased risk of PAH, the FDA recommends that a patient’s heart and lung health be evaluated prior to starting and during treatment with Sprycel. If PAH develops during treatment, Sprycel should be discontinued.

Patients who are taking Sprycel should be aware of the symptoms of PAH, and should discuss any symptoms that develop with their physician.

Source: US Food and Drug Administration. FDA Drug Safety Communication: Sprycel (dasatinib) and risk of pulmonary arterial hypertension. October 11, 2011.

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Tags: Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, Leukemia, News

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