Public recall detail

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

high
Recall Safety notice
Quick summary

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

Recommended action

Recommended action: stop using or consuming the product if you believe it matches the recall, review the official details, and follow the instructions from the official source.

Recall details

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

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

Brand

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).

Additional official information
Background{}
Companies
Audiences

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

Official source Monitor products Back to recalls

Starting...

Related recalls

Similar recalls and safety notices.

Loading related recalls...