Benlysta (belimumab) and risk of serious depression and/or suicidal ideation or behaviour or self-injury

GlaxoSmithKline would like to inform healthcare professionals about the risk of serious depression and/or suicidal ideation or behaviour or self-injury associated with Benlysta (belimumab). An imbalance in selected serious psychiatric events was reported in a recent one-year, randomised, double-blind, placebo-controlled post-marketing study of 4,003 subjects with systemic lupus erythematosus. The Benlysta package insert will be updated to include safety information on this risk. Healthcare professionals are advised to consider if patients are at risk before treatment with Benlysta, and to continue monitoring of their patients during treatment. Please refer to the letter for details.

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

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.