FDA Issues Sprycel PAH WarningOct 12, 2011 | Parker Waichman LLP
The U.S. Food & Drug Administration (FDA) announced yesterday that Sprycel, a drug used to treat certain types of leukemia, has been associated with rare cases of pulmonary arterial hypertension (PAH). In a Drug Safety Communication, the agency said information on this possible Sprycel side effect would be added to the "Warning and Precautions" section of the drug's label.
PAH is abnormally high blood pressure in the lungs that causes shortness of breath, fatigue, and swelling of the body (such as the ankles and legs). PAH causes the heart to work harder to pump blood to the lungs, which can eventually weaken the heart muscle.
According to the FDA, 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.
The FDA said Sprycel should be discontinued in patients with PAH, as doing so can reverse the condition. The agency is also advising doctors to evaluate patients for signs and symptoms of underlying cardiopulmonary disease prior to starting Sprycel and also during treatment.
Patients with PAH during Sprycel treatment were often taking other medications at the same time or had other co-existing medical conditions. Other medical conditions may also cause symptoms similar to those seen with PAH. Therefore, in symptomatic patients, if other causes have been ruled out, a diagnosis of Sprycel-associated PAH should be considered, the FDA said.