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

User Rating: 3 / 5

Star ActiveStar ActiveStar ActiveStar InactiveStar Inactive
 

 

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.

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Mobile Web :

Site Last Modified

  • Last Modified: Friday 18 October 2019, 10:30:39.
© Copyright 2019 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA

Main Menu English

Choose Your Language