OTTAWA, Ontario, Canada — On April 4, 2019, Health Canada announced that the lupus drug BENLYSTA (belimumab) might cause depression, suicidal thoughts, or behavior that leads to self-injury. Health Canada warns physicians and patients battling lupus to be wary of any symptoms indicative of depression while taking BENLYSTA (belimumab) and take the appropriate steps to ensure that the patient receives the mental health he or she needs while taking BENLYSTA (belimumab). GlaxoSmithKline manufactures the drug and is aware of the potential side effects.
According to Health Canada, the results of a clinical trial conducted after BENLYSTA (belimumab) received approval for marketing and distribution revealed that there is a substantial link between taking BENYLSTA (belimumab) and severe mental illness causing depression, suicidal thoughts, suicidal actions, and self-injury. None of the over 4,000 trial subjects committed suicide during the trial.
The purpose of the research was to examine all the causes of death for people taking BENLYSTA (belimumab). It is important to understand that the research did not exclude people taking the drug who have a known history of mental health disorders. The trial methodology compared the attitudes of two groups of people, one who took intravenous BENLYSTA (belimumab) and the other group who only had a placebo. The researchers conducting the study then measured the attitudes of the participants. The researchers observed that people receiving the BENLYSTA (belimumab) therapy displayed a propensity toward self-injury and depression than those in the placebo group.
The results are consistent with a trial conducted before BENLYSTA received governmental approval. Two people died by suicide during the pre-approval trial. As a result, GlaxoSmithKline must publish a warning on the product label cautioning physicians about the potential problem.
Health Canada urges prescribing physicians monitor their patients closely and refer patients to the appropriate mental health counselors immediately if depression or suicidal ideations present.
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