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Health Canada Advisory: Belimumab increased risk of serious harm, suicidal ideation

April 4, 2019

Healthcare professionals including rheumatologists, dermatologists, immunologists, internists, cardiologists, nephrologists, pulmonologists, neurologists, family physicians, nurses at clinics contracted to administer BENLYSTA, psychiatrists, psychologists, and pharmacists. 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.