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Health Canada warning about Benlysta (belimumab) for systemic lupus erythematosus

Serious adverse events of depression, suicidal ideation or behaviour, or self-injury were reported more frequently in patients with systemic lupus erythematosus receiving Benlysta than in patients receiving placebo during a post-marketing study 

Below is an excerpt from the safety alert published by Health Canada

Information for consumers

Benlysta is used in combination with other medicines to treat adults with lupus (systemic lupus erythematosus).

An increased risk of signs or symptoms of mental illness such as depression, thoughts of suicide and suicidal behaviour and mood changes have been observed in patients taking Benlysta.

Before taking the drug, patients should discuss with their healthcare professional if they have or have had signs or symptoms of mental illness such as depression, self-harm, and/or thoughts of suicide.

Patients receiving Benlysta should inform their healthcare professional if they experience signs or symptoms of mental illness such as thoughts of suicide or dying, thoughts of hurting themselves or others, attempting to commit suicide or acting on other dangerous impulses, trouble sleeping (insomnia), new or worse anxiety or depression, or other unexpected changes in their behaviour or mood. Patients receiving Benlysta should also inform their healthcare professional if they experience any other side effects or if they require additional information.

Information for healthcare professionals

Healthcare providers 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/or 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.

Action taken by Health Canada

Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication update will be further distributed through the MedEffect™ e-Notice email notification system. Health Canada is currently working with the manufacturer to update the Benlysta Canadian Product Monograph.