Benlysta® (belimumab): Increased risk of serious psychiatric events


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An increased risk of serious psychiatric events such as depression, suicidal ideation or behavior, including suicides, or self-injury, has been observed in patients with systemic lupus erythematosus (SLE) receiving belimumab plus standard therapy in clinical trials. This includes results recently obtained from a one-year, randomised, double-blind, placebo-controlled post marketing study (BEL115467) in 4,003 patients with SLE.


Healthcare professionals are recommended to:


NPRA has approved a Direct Healthcare Professional Communication (DHPC) letter issued by GlaxoSmithKline Pharmaceutical Sdn. Bhd. to highlight this safety issue. For further information, please contact your local sales person for a copy of the DHPC.