Sprycel May Increase Risk of Pulmonary Arterial Hypertension: FDA

The leukemia drug Sprycel has been linked to a rare form of hypertension that can wear down the heart’s ability to pump blood. 

On Tuesday, the FDA issued a drug safety communication warning that side effects of Sprycel may increase the risk of pulmonary arterial hypertension (PAH).

The medication could lead to abnormally high blood pressure that affects the arteries of the lungs, potentially weakening the heart, reducing its ability to pump blood through the lungs, leading to fatigue, shortness of breath and swelling in the lower extremities.

According to federal health regulators, there are at least 12 confirmed cases of pulmonary arterial hypertension (PAH) believed to be caused by Sprycel. The drug has only been used by about 33,000 patients worldwide since 2006.

No fatalities have been linked to Sprycel PAH and the FDA believes it may be reversible once the patient is taken off Sprycel and given the proper treatment.

Sprycel (dasatinib) was approved by the FDA in June 2006 for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). It prevents cancer cells from multiplying by blocking the action of an abnormal protein.

The FDA recommends that any patients taking Sprycel alert their healthcare professional immediately if they develop PAH symptoms, which can include shortness of breath, fatigue or swelling in the ankles or legs.

Doctors are urged to immediately and permanently remove any patient with PAH from Sprycel treatment. The FDA also recommends that patients be evaluated for signs and symptoms of cardiopulmonary disease before being put on Sprycel. Doctors should exclude other potential causes of PAH, including pleural effusion, pulmonary edema, anemia and lung infiltration.

The new information on Sprycel PAH side effects is being added to the drug’s warning label. The FDA is asking any doctors or patients who experience an adverse event linked to Sprycel to report those problems to MedWatch, the FDA’s adverse event reporting program.