As if having leukemia isn’t bad enough to deal with, now one of the drug’s prescribed to leukemia patients is being linked to causing abnormally high blood pressure within the lungs. In this article, let’s look at the drug a little more in detail, and discuss why an FDA warning has now been issued.
Apparently according to a U.S. Food & Drug Administration (FDA) alert just issued, the agency is aware of a dozen reports of Pulmonary Arterial Hypertension (PAH) occurring in patients taking Sprycel. Information regarding the possible risk of PAH is being added to the “Warnings and Precautions” section of the U.S. label for Sprycel (dasatinib).
Sprycel, a leukemia drug made by Bristol-Myers Squibb, was approved in 2006. According to the FDA, Sprycel is used to treat certain adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL). It prevents cancer cells from multiplying by blocking the action of an abnormal protein. The drug has only been used by about 33,000 patients worldwide since 2006.
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.
PAH forces the heart to work harder to pump the blood into the lungs. Over time, the overworked heart muscle may become weak and lose its ability to pump enough blood through the lungs. Symptoms of PAH may include shortness of breath, fatigue, and swelling of the body (such as the ankles and legs).
In the Drug Safety Communication issued October 11, 2011, the FDA said 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.
According to the FDA, many of the PAH victims detailed in the reports had other conditions or were taking other medications that could result in PAH. In patients with symptoms, a diagnosis of Sprycel-associated PAH should be considered if other causes have been ruled out.
The FDA recommends that any patients taking Sprycel alert their healthcare professional immediately if they develop PAH symptoms. Doctors are then urged to immediately and permanently remove any patient with PAH from Sprycel treatment.
They also recommend 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.
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.