Dasatinib May Raise Risk for Pulmonary Arterial Hypertension


October 11, 2011

October 11, 2011 — The leukemia drug dasatinib (Sprycel, Bristol-Myers Squibb) may increase the risk for pulmonary arterial hypertension (PAH), a rare but serious disorder that clinicians must parse out from other conditions with similar symptoms, the US Food and Drug Administration (FDA) announced today.

PAH can weaken the heart by forcing it to work harder to pump blood into the lungs. Symptoms of PAH include shortness of breath, fatigue, and swollen ankles and legs.

Dasatinib is indicated for certain adult patients with Philadelphia chromosome–positive chronic myeloid leukemia or acute lymphoblastic leukemia. Since the drug's initial approval in 2006, cases of PAH have cropped up in the manufacturer's global database of adverse events. Twelve cases were confirmed by right-heart catheterization and attributed in all likelihood to dasatinib.

Patients diagnosed with PAH during dasatinib therapy often took other medications at the same time or had other conditions with symptoms mimicking PAH. The FDA reasons that a combination of such factors may contribute to the development of PAH in patients receiving the drug.

The FDA is advising clinicians to evaluate patients for signs and symptoms of underlying pulmonary disease before prescribing dasatinib, as well as during treatment. In symptomatic patients taking the drug, clinicians should consider a diagnosis of dasatinib-related PAH if they rule out other causes. If they confirm the diagnosis through right-heart catheterization, they should permanently discontinue the drug, according to the agency. PAH may be reversible once patients stop taking dasatinib.

The FDA is adding information about the risk for PAH to the drug's label.

More information about today's FDA announcement is available on the agency's Web site.

To report adverse events related to dasatinib, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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