FDA warns Bristol’s leukemia drug may raise lung risks

Health regulators warned on Tuesday that Bristol-Myers Squibb Co’s leukemia drug Sprycel may raise the risk of a rare, but serious condition characterized by abnormally High Blood Pressure in the arteries of the lungs.

The condition, known as pulmonary arterial hypertension (PAH), makes the heart work harder to pump blood into the lungs. Over time, the overworked heart muscle may become weak and lose its ability to pump enough blood through the lungs.

Sprycel was initially approved in the United States in June 2006. Since approval, cases of PAH have been identified in Bristol-Myers’ global pharmacovigilance database. No fatalities from the condition have been reported, the U.S. Food and Drug Administration said on its website.

Twelve cases of PAH from the manufacturer’s database were confirmed, and Sprycel was identified as the most likely cause, FDA said.

FDA said that if PAH is confirmed in a patient, Sprycel should be permanently discontinued.

(Reporting by Esha Dey in Bangalore; Editing by Supriya Kurane)

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(Reuters)