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.

 
 
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.moh.gov.sg/hpp/, and follow the procedures below to access the MOH Alert system.

Step 1: On the top navigation ribbon of webpage, select 'For Healthcare Professionals' followed by 'Health Professionals Portal' and click on the choice of profession. User will be redirected to the specific HPP webpage for the selected profession.

Step 2: Click on the Restricted Content icon on the left panel of webpage and login via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’ section

Step 4: Click on the Drug Alert tab to view the DHCPLs.