FDA Adds New Warnings to Bristol Cancer Drug
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 patients' lung arteries.
The Food and Drug Administration said 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.
Sprycel is used to treat certain adults with two forms of leukemia, a cancer of the blood and bone marrow.
The FDA says doctors should evaluate patients for lung and heart problems before deciding whether to prescribe Sprycel.
Calls placed to Bristol-Myers Squibb were not immediately returned Tuesday.