PAH Warning Added to Sprycel Label, FDA Says

Information regarding a possible risk of pulmonary arterial hypertension (PAH) is being added to the “Warnings and Precautions” section of the U.S. label for <"">Sprycel (dasatinib). According to a U.S. Food & Drug Administration (FDA) alert issued yesterday, the agency is aware of a dozen reports of PAH – abnormally high blood pressure in the lungs – occurring in Sprycel patients

Sprycel, a leukemia drug made by Bristol-Myers Squibb, was approved in 2006. According to the FDA, Sprycel is used to treat certain adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL).

In the Drug Safety Communication issued yesterday, the FDA said 12 cases of PAH in which Sprycel was the most likely cause were reported in the manufacturer’s database and confirmed by right heart catheterization. In these cases, symptoms were reported and PAH diagnosed after initiation of Sprycel therapy. Patients developed PAH after receiving Sprycel therapy for various time intervals, including more than one year.

According to the FDA, many of the PAH victims detailed in the reports had other conditions or were taking other medications that could result in PAH. In patients with symptoms, a diagnosis of Sprycel-associated PAH should be considered if other causes have been ruled out.

The FDA is advising doctors to 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.

PAH forces the heart to work harder to pump the blood into the lungs. Over time, the overworked heart muscle may become weak and lose its ability to pump enough blood through the lungs. Symptoms of PAH may include shortness of breath, fatigue, and swelling of the body (such as the ankles and legs).

In August, the Canadian drug regulator, Health Canada, issued a PAH warning for Sprycel, also detailing the 12 case of PAH confirmed by right heart catheterization linked to treatment with Sprycel. In total, Health Canada said 36 cases of pulmonary hypertension and 24 cases of PAH had been reported in Sprycel patients worldwide.

This entry was posted in Sprycel. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.