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FDA Drug Safety Podcast for Healthcare Professionals: Sprycel (dasatinib) and risk of pulmonary arterial hypertension

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Welcome, my name is Jennifer Shepherd, a pharmacist in the Division of Drug Information. On October 11, 2011, the Food and Drug Administration issued a Drug Safety Communication warning the public that the leukemia drug Sprycel, active ingredient dasatinib, may increase the risk of a rare, but serious condition in which there is abnormally high blood pressure in the arteries of the lungs, known as pulmonary arterial hypertension, or PAH. Information about this risk has been added to the Warnings and Precautions section of the Sprycel drug label.

As a result of PAH, the heart must 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 reported cases, patients developed PAH after starting Sprycel, including after more than one year of 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. PAH may be reversible if Sprycel is discontinued.  

Healthcare professionals should evaluate patients for signs and symptoms of underlying cardiopulmonary disease prior to starting Sprycel and also during treatment. If PAH is confirmed, Sprycel should be permanently discontinued.

At this time, FDA recommends that Healthcare Professionals be aware that:

  1. Sprycel may increase the risk of PAH which may occur anytime after initiation, including after more than one year of treatment.
  2. Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to initiating Sprycel and during treatment.
  3. Patients with PAH during Sprycel treatment were often taking concomitant medications or had co-morbidities.
  4. Symptoms of PAH include dyspnea, fatigue, hypoxia, and fluid retention.
  5. Before initiating invasive procedures, more common etiologies of dyspnea associated with Sprycel therapy should be excluded, including pleural effusion, pulmonary edema, anemia, and lung infiltration.
  6. Since PAH may be reversible upon discontinuation of Sprycel, a diagnostic approach of interruption of Sprycel treatment may be considered to observe for improvement.
  7. Right heart catheterization can confirm the diagnosis by showing normal pulmonary capillary wedge pressure (<15 mm Hg) but elevated pulmonary artery, or PA, pressure (mean PA pressure >25 mm Hg), indicating that the hypertension is "pre-capillary" and is not a consequence of left heart failure or chronic lung disease.
  8. If PAH is confirmed, Sprycel should be permanently discontinued.
  9. Adverse events involving Sprycel should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. Please read the Drug Safety Communication for the complete Data Summary detailing this communication. A link to this communication can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

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