Important Safety Information regarding PrBENLYSTA (belimumab)

Increased Risk of Serious Depression, Suicidal Ideation or Behaviour, or Self-Injury

The Canadian Rheumatology Association would like to inform its members of the following advisory:

In a recent post-marketing study (BEL115467), depression, suicidal ideation or behaviour, and self-injury were reported more frequently in patients receiving BENLYSTA plus standard therapy, when compared to patients taking placebo plus standard therapy.

Healthcare professionals are advised to:

  • Evaluate the risk of depression, suicidal ideation or behaviour, and self-injury before starting and during treatment with BENLYSTA.
  • Advise patients and their caregivers to contact a healthcare provider if patients experience new or worsening depression, suicidal ideation or behaviour, or self-injury.
  • Evaluate and refer patients experiencing new or worsening depression, suicidal ideation or behaviour, or self-injury to a mental health professional, as needed.

Health Canada is currently working with the manufacturer to update the BENLYSTA Canadian Product Monograph regarding this risk, including data from the post-marketing study (BEL115467).

For more information, please contact GlaxoSmithKline Inc. Medical Information at 1800-387-7374.

More information (View PDF)

2019-04-09T13:52:59+00:00