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

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BlankLeukemia 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 a Drug Safety Communication. The FDA says doctors should

check patients for signs and symptoms of underlying cardiopulmonary disease

before considering prescribing Sprycel - they should also evaluate patients

during treatment.

Pulmonary arterial hypertension, also known as pulmonary hypertension or PAH 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.