Health Canada Issues Safety Alert for Lupus Drug

OTTAWA, Ontario, Canada — Health Canada, the governmental organization who oversees the safety of medications and medical therapies in Canada, issued an urgent safety warning to people taking the intravenous drug BENLYSTA (belimumab) for SLE or systemic lupus erythematosus (lupus) could experience substantial mental health disorders such as depression, suicidal thoughts, or injuring themselves. Health Canada issued the warnings on April 4, 2019, after the results of a post-approval trial were released. Health Canada did not recall the drug and Health Canada has not ordered changes to marketing and product information materials at this time, but changes are forthcoming. GlaxoSmithKline, the makers of BENLYSTA (belimumab), are cooperating with Health Canada’s efforts to ensure that lupus patients taking the drug receive the mental health care they need.

Researchers who conducted a post-approval study of BENLYSTA (belimumab) found that patients who took the active drug rather than the placebo showed a significantly higher incidence of suffering from major depression, suicidal thoughts, and thoughts about injurious behavior. Researchers did not exclude lupus patients who had a history of depression from the study. As a result of these findings, Health Canada may order GlaxoSmithKline to include updated information learned from the survey in the medication’s marketing and product information. None of the participants in the study followed through on his or her suicidal thoughts. However, in a pre-approval study, two patients died by their own hand while talking BENLYSTA (belimumab). That information already appears in the product information and warnings.

Health Canada urged doctors who prescribe BENLYSTA (belimumab) to monitor their patients’ mental health closely. Health Canada directed physicians to counsel their patients to be watchful for new or worsening symptoms of depression and to seek mental health counseling as soon as possible. All cases in which mental health side effects are noted should be reported to Health Canada and GlaxoSmithKline as well.

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