On the heels of the Canadian warning
Bristol-Myers Squibb Co. (BMY)'s leukemia drug Sprycel may increase the risk of a rare condition that causes high blood pressure in the lungs' arteries, U.S. regulators said today.
Health-care providers should evaluate patients for signs of underlying cardiopulmonary disease before starting Sprycel, chemically known as dasatinib, and during treatment. If abnormally high blood pressure known as pulmonary arterial hypertension is confirmed, patients should discontinue the medicine, according to the safety announcement from the Food and Drug Administration.
Twelve cases of pulmonary arterial hypertension tied to Sprycel were confirmed from New York-based Bristol's pharmacovigilance database. No fatalities have been reported. High blood pressure can cause the heart to work harder and eventually become weak and lose its ability to pump enough blood through the lungs, the FDA said.
"Patients with PAH during Sprycel treatment were often taking other medications at the same time or had other co- existing medical conditions," FDA said.
The agency estimated that 32,882 patients worldwide have taken Sprycel for Philadelphia chromosome-positive chronic myeloid leukemia or acute lymphoblastic leukemia. The drug was approved in June 2006.
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