FDA Warns Leukemia Drug Could Increase Risk for Rare Blood Pressure Problem

The U.S. Food and Drug Administration recently issued a new drug safety communication, in which the agency reported that the Bristol-Myers Squibb leukemia drug, Sprycel, could potentially increase a patient’s risk for developing a rare high blood pressure problem in the lungs, known as pulmonary arterial hypertension, or PAH.

PAH is a condition that causes the heart to work much harder to pump blood into the lungs and can ultimately weaken the heart muscle altogether, hindering its ability to properly function. According to the FDA, the label for Sprycel has now been updated to reflect the new warning regarding the increased risk for pulmonary arterial hypertension.

Sprycel was approved by federal regulators in 2006 to treat certain types of blood and bone-marrow cancers, and it has now been used to treat approximately 33,000 patients worldwide. The FDA reports that cases of PAH were found in a Bristol-Myers Squibb database designed to capture and report side-effects associated with use of their prescription medications. It is important to note that symptoms of PAH include, shortness of breath, fatigue, and swelling of the arms and legs.

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