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:

  • Carefully assess the risk of depression, suicidal ideation or behavior, or self-injury, and consider patient’s medical history and current psychiatric status before initiating Benlysta® treatment.
  • Monitor for signs of psychiatric events during treatment.
  • Advise patients and caregivers to promptly seek medical attention in the event of new or worsening depression, suicidal ideation or behavior, or self-injury.


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.


National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400



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  • Last Modified: Khamis 13 Jun 2024, 10:32:42.
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