Pulmonary Arterial Hypertension (PAH) reported with SPRYCEL® (dasatinib)

Bristol‐Myers Squibb (BMS), in consultation with the Health Sciences Authority (HSA), would like to inform you of important safety information for SPRYCEL® (dasatinib). A recent review of the BMS pharmacovigilance database had identified 12 cases of pulmonary arterial hypertension (PAH) in association with SPRYCEL® (dasatinib) treatment. In these cases, PAH was reported even after more than one year of treatment and patients were often taking concomitant medications or had comorbidities. The causal role of SPRYCEL® (dasatinib) in these post‐marketing reports of PAH was considered likely. Improvements were observed in some patients following cessation of SPRYCEL® (dasatinib). The Prescribing Information for SPRYCEL® (dasatinib) has been updated to include an additional warning on PAH. Healthcare professionals are recommended to follow current standard published clinical consensus guidelines for the diagnosis and management of patients with signs and symptoms suggestive of PAH.