Leukemia Drug Sprycel (Dasatinib) Has Risk Of Pulmonary Arterial Hypertension, Warns FDA

Sprycel (dasatinib), a leukemia medication raises the risk of developing pulmonary arterial hypertension, the US Food and Drug Administration (FDA) announced today in aDrug Safety Communication. The FDA says doctors should check patients for signs and symptoms of underlying cardiopulmonary disease before considering prescribingSprycel - they should also evaluate patients during treatment.

Pulmonary arterial hypertension, also known as pulmonary hypertension orPAH is a kind of high blood pressure that only affects the arteries in the lung and the right side of the patient's heart. It starts when the pulmonary arteries and capillaries become narrowed, blocked or damaged, making it harder for blood to flow through the lungs. This raises pressure within the arteries in the lungs. Pressure builds up, making the right ventricle of the heart - the lower right chamber - have to work harder to pump blood through to the lungs. The heart muscle eventually weakens, and if left untreated may fail completely.

PAH is a serious illness that tends to get worse with time. PAH is potentially fatal.

Signs and symptoms of pulmonary arterial hypertension include fatigue, shortness of breath, swelling of the ankles and legs (and possibly other parts of the body), non-productive cough,angina pectoris, syncope, and in rare cases coughing up blood.

The FDA has received reports of patients who started on Sprycel developing PAH, in some cases after over a year on the medication. Some of the patients were on other drugs simultaneously, or had other underlying co-existing medical conditions. Some medical conditions may cause PAH-like symptoms. The FDA says that patients with symptoms who have other conditions ruled out, should be considered for a diagnosis of Sprycel-associated PAH.

If Sprycel-associated PAH is confirmed, the medication should be permanently discontinued, the FDA added.

The FDA stresses that if Sprycel treatment is discontinued, the PAH is reversible.

If you are a patient taking Sprycel and experience PAH-like symptoms, contact your doctor immediately.

The FDA is telling doctors that 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."

Sprycel (dasatinib) has been on the market in the USA since June 2006. Since 2006, Bristol-Myers Squibb, the makers of the medication, have received cases of PAH. However, no deaths directly related to dasatinib usage have been reported.

The company received 12 cases of PAH which were confirmed by right heart catheterization (Sprycel most likely cause). In many cases patients were taking other medications and had other underlying medical conditions.

The FDA wrote on its website:

"There may be a combination of factors contributing to the development of PAH in patients taking Sprycel. In some cases, improvements in hemodynamic and clinical parameters were observed following discontinuation of Sprycel."

Patients and doctors are encouraged to report any serious problems to:

• Tel:             1-800-332-1088      
• Fax: 1-800-FDA-0178
• MedWatch Online
• Regular Mail: Use postage-paid FDA Form 3500. Mail to: MedWatch 5600 Fishers Lane, Rockville, MD 20857

Dasatinib, chemical formula C₂₂H₂₆ClN₇O₂S, is an oral multi- BCR/ABL and Src family tyrosine kinase inhibitor approved for use in patients with chronic myelogenous leukemia (CML) after imatinib treatment and Philadelphia chromosome-positive acute lymphoblastic leukemia.

Written by Christian Nordqvist 

View drug information on Sprycel.