其 他 安 全 警 示
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| Australia: More prominent safety warnings about the neuropsychiatric effects of montelukast (English only) |
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The Therapeutic Goods Administration (TGA) announces that additional safety information is being added to all montelukast products to strengthen and highlight existing warnings about serious neuropsychiatric events. These include behavioural changes, depression and suicidal thoughts and behaviour. The safety information includes a new boxed warning and additional guidance for prescribers and patients on the management of serious neuropsychiatric events.
This safety update follows a TGA safety investigation conducted in 2024 after international regulators strengthened warnings about neuropsychiatric events for montelukast products. The update brings the Australian Product Information (PI) and Consumer Medicine Information (CMI) in line with international regulatory advice.
Montelukast is a prescription medicine used to prevent and treat chronic asthma in adults and children aged 2 years and older, and for symptomatic seasonal allergic rhinitis (hay fever).
The risks of neuropsychiatric events with montelukast are already well documented in both the PI and CMI. In July 2018, the TGA published a review of montelukast and neuropsychiatric adverse events. This evaluated the medical literature and included consultation with international regulators and expert advice from the Advisory Committee on Medicines (ACM).
In 2024, an updated TGA safety investigation was conducted after international regulators strengthened their warnings about neuropsychiatric events. Expert advice from the ACM concluded that up-to-date information did not identify any new neuropsychiatric risks and existing evidence for the association between montelukast and neuropsychiatric risks remained uncertain. The expert group recommended adding a boxed warning in the Australian PI to align with international regulators.
A search of TGA’s publicly available Database of Adverse Event Notifications (DAEN) on 18 December 2024 identified 356 cases for montelukast and psychiatric disorders. The most commonly reported symptoms were aggression (100 cases), anxiety (87 cases), suicidal ideation (72 cases), depression (71 cases), insomnia (52 cases) and nightmare (50 cases). There were 91 reports that mentioned suicidal behaviours. Of these, 10 reported a fatal outcome. It is important to note that inclusion in the DAEN does not mean that the details of the reported event have been confirmed, or that the event has been determined to be related to a medicine.
The following boxed warning will be included in the Australian PIs for montelukast products:
- WARNING:
Serious neuropsychiatric events
Neuropsychiatric events such as behavioural changes, depression and suicidality have been reported in all age groups taking montelukast (see sections 4.4 and 4.8). Events are generally mild and may be coincidental. However, the symptoms may be serious and continue if the treatment is not withdrawn. Therefore, the treatment with montelukast should be discontinued if neuropsychiatric symptoms occur during treatment. Advise patients and/or caregivers to be alert for neuropsychiatric events and instruct them to notify their physician if these changes in behaviour occur.
Additional advice to prescribers will also be included in the existing information on neuropsychiatric events in Section 4.4 Special warnings and precautions of the PI, as follows:
- Neuropsychiatric events
Prescribers should discuss the benefits and risks of montelukast use with patients and caregivers when prescribing montelukast. Patients and/or caregivers should be advised to be alert for changes in behaviour or for new neuropsychiatric symptoms when taking montelukast. If changes in behaviour are observed, or if new neuropsychiatric symptoms or suicidal thoughts and/or behaviour occur, patients should be advised to discontinue montelukast and contact a healthcare provider immediately. In many cases, symptoms resolved after stopping montelukast therapy; however, in some cases symptoms persisted after discontinuation of montelukast. Therefore, patients should be monitored and provided supportive care until symptoms resolve. Prescribers should carefully evaluate the risks and benefits of continuing treatment with montelukast if such events occur.
Health professionals are reminded about the potential neuropsychiatric effects associated with montelukast. These effects have been reported in all age groups taking montelukast, are generally mild and may occur by chance. However, symptoms can be serious and continue if treatment is not stopped. In rare cases, patients taking montelukast have died after experiencing suicidal behaviour.
Health professionals should be vigilant for neuropsychiatric reactions in patients taking montelukast and discontinue treatment if new or worsening symptoms occur. Advise patients and their carers to be alert for changes in behaviour or for new neuropsychiatric symptoms and to seek medical advice immediately should they occur. Consider providing the CMI to remind patients of these effects.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-updates/more-prominent-safety-warnings-about-neuropsychiatric-effects-montelukast
In Hong Kong, there are 58 registered pharmaceutical products containing montelukast. All products are prescription-only medicines. So far, with regard to montelukast, the Department of Health (DH) has received 7 cases of adverse drug reaction, of which 5 cases were reported as neuropsychiatric events.
Related news on the risk of neuropsychiatric events associated with the use of montelukast was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 15 Jun 2009, with the latest update posted on 30 Apr 2024. Letters to remind local healthcare professionals were issued by the DH on 20 Sep 2019 and 5 Mar 2020. In Apr 2021, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and decided that the sales pack label and/or package insert of montelukast-containing products should include the relevant safety information, including the strengthened warnings in the above TGA’s announcement. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Friday, Jan 17, 2025
Issued at HKT 17:45
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