Description
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.
