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Health Canada Health products

PrBENLYSTA (belimumab) - Increased Risk of Serious Depression, Suicidal Ideation or Behaviour, or Self-Injury

Issued April 4, 2019
Issue
Serious adverse events of depression, suicidal ideation or behaviour, or self-injury were reported more frequently in patients with systemic lupus erythematosus (SLE) receiving BENLYSTA than in patients receiving placebo during a post-marketing study (BEL115467).
Hazard description
Product safety