FDA adds new warnings to Bristol cancer drug
Wednesday, October 12, 2011
WASHINGTON (AP) — Federal health officials are warning doctors about a rare but dangerous side effect of a Bristol-Myers Squibb leukemia drug that can cause abnormally high blood pressure in the arteries in patients' lungs.
The Food and Drug Administration said Tuesday the company's drug Sprycel will carry a new warning about increased risk of pulmonary arterial hypertension, which causes shortness of breath, fatigue and swelling of the limbs. The problem has been reported in patients taking the drug for more than a year, according to an online posting by the agency.
Sprycel is used to treat certain adults with two forms of leukemia. Leukemia is a cancer of the blood and bone marrow. The drug posted sales of $576 million in 2010.
The FDA says doctors should evaluate patients for lung and heart problems before deciding whether to prescribe Sprycel.
New York-based Bristol-Myers Squibb said it has received 15 reports of the lung artery problem since June 2006.
"We are in discussions with health authorities worldwide about how to appropriately update product information and provide health care professionals with information supporting the safe and appropriate use of Sprycel," the company said in a statement.