Other safety alerts
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| Singapore: Benlysta (belimumab) and risk of serious depression and/or suicidal ideation or behaviour or self-injury |
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Health Sciences Authority (HSA) announces that GlaxoSmithKline would like to inform healthcare professionals about the risk of serious depression and/or suicidal ideation or behaviour or self-injury associated with Benlysta (belimumab).
An imbalance in selected serious psychiatric events was reported in a recent one-year, randomised, double-blind, placebo-controlled post-marketing study of 4,003 subjects with systemic lupus erythematosus. The Benlysta package insert will be updated to include safety information on this risk. Healthcare professionals are advised to consider if patients are at risk before treatment with Benlysta, and to continue monitoring of their patients during treatment.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../benlysta-belimumabandriskofseriousdepressionandorsuicidalideatio.html
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”. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Wednesday, Mar 20, 2019
Issued at HKT 15:00
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