Other safety alerts
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| Canada: BENLYSTA (belimumab) - Increased Risk of Serious Depression, Suicidal Ideation or Behaviour, or Self-Injury |
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Health Canada announces that 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).
BENLYSTA is a human IgG1-lambda monoclonal antibody specific for soluble human B Lymphocyte Stimulator indicated for use in addition to standard therapy for reducing disease activity in adult patients with active, autoantibody-positive, systemic lupus erythematosus.
Recently, a one-year post-marketing study (BEL115467) was conducted to evaluate all-cause mortality and some adverse events including selected serious psychiatric events. This study was a randomized, double-blind, placebo-controlled post- marketing study of 4,003 subjects with SLE. The study did not exclude subjects who had a previous history of psychiatric/mood disorders.
An increase in serious adverse events of depression and suicidal ideation or behaviour or self-injury compared to placebo was observed. Suicidal ideation or behaviour or self-injury was reported in 0.7% (n= 15) of subjects receiving belimumab intravenously (IV) 10mg/kg vs. 0.2% (n=5) of subjects taking placebo. Serious depression was reported in 0.3% (n=7) of subjects receiving belimumab 10mg/kg IV vs. <0.1% (n=1) taking placebo. No suicide-related deaths were reported in BEL115467.
Reports of depression, suicidal thoughts and suicide attempts in the pivotal trial programme (including 2 completed suicides) in patients receiving BENLYSTA have previously been included in the Warnings and Precautions and Adverse Drug Reactions sections of the BENLYSTA Canadian Product Monograph.
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.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../69506a-eng.php
In Hong Kong, Benlysta Powder For Concentrate For Solution For Infusion 120mg (HK-61384) and Benlysta Powder For Concentrate For Solution For Infusion 400mg (HK-61385) are registered pharmaceutical products containing belimumab. These products are registered by GlaxoSmithKline Limited (GlaxoSmithKline), and are prescription-only medicines. So far, the Department of Health (DH) has received 2 cases of adverse drug reaction related to belimumab, but these cases are not related to depression, suicidal ideation or behaviour or self-injury.
In Mar 2019, GlaxoSmithKline submitted application for change of product insert for the above products to include warnings on depression and suicidality. The DH is working with the company to update the safety information of the products. Adverse effects and precautions of depression and suicide are also documented in overseas reputable drug references such as the “Martindale: The Complete Drug Reference”.
Related news was also issued by the Singapore Health Sciences Authority, and was posted on the Drug Office website on 20 Mar 2019. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Saturday , April 6, 2019
Issued at HKT 12:50
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