FDA Adds Warning to Leukemia Drug Sprycel
The FDA said the drug can increase the risk of pulmonary arterial hypertension. The potential risk has been added to the warnings and precautions section of Sprycel's label.
The US FDA has released a new safety announcement with a new warning about Bristol-Myers Squibb's leukemia treatment Sprycel.
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.
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