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.