FDA warns Bristol’s leukemia drug may raise lung risks

Sprycel was initially approved in the United States in June 2006. Since approval, cases of PAH have been identified in Bristol-Myers’ global pharmacovigilance database. No fatalities from the condition have been reported, the U.S. Food and Drug Administration said on its website.Twelve cases of PAH from the manufacturer’s database were confirmed, and Sprycel was identified as the most likely cause, FDA said.FDA said that if PAH is confirmed in a patient, Sprycel should be permanently discontinued.

@3 years ago with 36 notes
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  1. jodyglpmott posted this