Risk of atypical fracture with Prolia®(denosumab)

GlaxoSmithKline (GSK) would like to notify you of the risk of atypical femoral fracture with Prolia®. Cases of atypical femoral fracture have been confirmed in patients receiving Prolia® participating in the ongoing open-label extension study of the pivotal phase 3 fracture trial in postmenopausal osteoporosis (FREEDOM). These events have occurred very rarely (<1/10,000) based on 31,266 subject-years exposed to Prolia® in bone loss studies. To communicate this important information, the Prolia® package insert has been updated with a new warning on atypical femoral fracture and inclusion of atypical femoral fracture as an adverse drug reaction. Please refer to the letter for more information.

 
 
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.