Bristol-Myers Squibb's ($BMY) leukemia treatment Sprycel has a new warning. In a new safety announcement, the FDA said the drug can increase the risk of pulmonary arterial hypertension (PAH). The potential risk has been added to the warnings and precautions section of Sprycel's label.
Cases of PAH were identified by BMS's database of adverse-event reports, which the company uses to track potential side effects. The 12 Sprycel patients who developed PAH were also taking other drugs, the agency said, or had preexisting conditions that might have helped spur development of PAH. But Sprycel was the most likely cause in these 12 cases, the agency said. More than 30,000 patients worldwide have used the drug since it was approved in 2006.
Doctors should evaluate patients for potential cardiopulmonary disease before they begin therapy with Sprycel and should be monitored during treatment. The PAH problem could be reversible with cessation of Sprycel treatment, the FDA said.