其 他 安 全 警 示
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| The United Kingdom: Belimumab (Benlysta▼): increased risk of serious psychiatric events seen in clinical trials (English Only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that clinical trials, including interim findings from a randomised trial, show an increased risk of depression, suicidal ideation or behaviour, or self-injury in patients with systemic lupus erythematosus receiving belimumab compared with those receiving placebo in addition to standard therapy.
An imbalance in rates of psychiatric events was observed in the clinical studies that led to the approval of belimumab. Assessment found the benefits of belimumab to outweigh the risks. However, as a condition of its licence, the marketing authorisation holder for belimumab was requested by regulators to conduct a randomised, placebo-controlled clinical trial (BEL115467) to evaluate all-cause mortality and pre-specified adverse events of special interest, including selected serious psychiatric events. The study is global and currently ongoing.
1-year data from this study show that, compared with patients who received placebo plus standard therapy, more patients who received belimumab plus standard therapy reported events of serious depression and suicidal ideation or behaviour or self-injury.
Healthcare professionals are advised:
- An increased risk for serious psychiatric events (depression, suicidal ideation or behaviour [including death by suicide], or self-injury) has been observed in patients receiving belimumab from clinical trials, including recent interim findings from a randomised trial.
- Carefully assess the risk of depression and suicide, considering the patient’s medical history and current psychiatric status, before belimumab is started.
- Monitor all patients for new or worsening signs of these risks during treatment.
- In patients with new psychiatric symptoms or if existing psychiatric symptoms worsen, assess the benefits and risks of continuing treatment.
Patients (and caregivers if appropriate) are advised:
- People taking belimumab may experience changes in their mood or behaviour, and should promptly seek medical attention if they experience new or worsening depression, suicidal ideation, or thoughts about injuring themselves
- Patients may wish to let family and friends know they are taking belimumab so they can look out for any changes in mood
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/belimumab-benlysta-increased-risk-of-serious-psychiatric-events-seen-in-clinical-trials
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.
Related news was previously issued by Singapore Health Sciences Authority and Health Canada, and was posted on the Drug Office website on 20 Mar 2019 and 6 Apr 2019.
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, Apr 17, 2019
Issued at HKT 16:00
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