FDA warns of pulmonary arterial hypertension risk with Bristol-Myers' Sprycel

The US Food and Drug Administration is warning the public that drug major Bristol-Myers Squibb’s (NYSE BMY) leukemia drug Sprycel (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 (pulmonary arterial hypertension; PAH).

12 cases of PAH from the manufacturer's database were confirmed, and Sprycel was identified as the most likely cause, FDA noted. The agency said that information about this risk has been added to the Warnings and Precautions section of the Sprycel drug label, which is approved to treat certain adult patients with Philadelphia chromosome-positive chronic myeloid leukemia or acute lymphoblastic leukemia.

Sprycel, which is co-marketed with Japan’s Otsuka, posted sales of $576 million in 2010, and $193 million in the second quarter of 2011, a year-on-year increase of 46%. B-MS said it is in discussions with health authorities worldwide "about how to appropriately update product information" and provide information "supporting the safe and appropriate use of Sprycel."