In a new drug-safety communication posted on the FDA’s website, 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 (PAH).
According to the FDA’s safety communication, the drug’s label has been updated to reflect the new warning regarding pulmonary arterial hypertension, a condition which causes the heart to work harder to pump blood into the lungs. In time, the heart becomes weak, losing its ability to properly pump blood.
Approved by the FDA in 2006 for the treatment of certain types of blood and bone-marrow cancers, Sprycel has 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. Symptoms of PAH include, shortness of breath, fatigue, and swelling of the arms and legs.