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FDA warning for BMS’ leukaemia drug

The US Food and Drug Administration has updated the label of Bristol-Myers Squibb's leukaemia drug Sprycel with a warning that the drug can increase the risk of abnormally high blood pressure in the arteries of the lungs

The US Food and Drug Administration (FDA) has updated the label of Bristol-Myers Squibb's (BMS) leukaemia drug Sprycel (dasatinib) with a warning that the drug can increase the risk of abnormally high blood pressure in the arteries of the lungs.

The condition, known as pulmonary arterial hypertension (PAH) is a potentially serious disorder that can weaken the heart and cause shortness of breath, fatigue, and swelling of the body.

The FDA made the updates to Sprycel's label based on data contained in BMS' global pharmacovigilance database that some patients developed PAH after starting Sprycel, including after more than one year of treatment.

Sprycel was initially approved in the US in June 2006. No fatalities from the condition have been reported, according to the FDA.

The regulatory agency also stated that patients diagnosed with PAH during Sprycel therapy were often taking other medications at the same time, and there may be a combination of factors contributing to the development of PAH in patients taking Sprycel.

Healthcare professionals are advised to 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.

12th October 2011

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