引 致 更 改 给 病 人 的 产 品 资 讯 的 药 物 不 良 反 应 警 示
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| Singapore: Advisory on restriction on the use of montelukast and neuropsychiatric effects (English only) |
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Health Sciences Authority (HSA) announces that it has completed a benefit-risk assessment of montelukast which concluded that the benefit-risk profile of montelukast remains favourable for its approved indication, if additional precautionary measures are put in place to mitigate the known but rare risk of neuropsychiatric events. These measures include restricting the use of montelukast in the treatment of allergic rhinitis to patients who have inadequate response or are intolerant to alternative therapies, and the strengthening of existing warnings on neuropsychiatric risks in the package inserts of montelukast-containing products. Healthcare professionals are advised to consider the benefits of treatment and risks of neuropsychiatric effects before prescribing montelukast.
In Mar 2020, HSA initiated a safety review on montelukast in response to the regulatory actions taken by the United States Food and Drug Administration (FDA) to include a Boxed Warning on serious behaviour and mood-related changes with montelukast and to restrict the use of montelukast in the treatment of allergic rhinitis in patients with inadequate response or intolerance to alternative therapies. FDA’s review did not identify new evidence regarding the known neuropsychiatric safety concern but highlighted a lack of awareness of healthcare professionals to this safety issue despite earlier communications by the agency. Internationally, several regulatory agencies had also incorporated restrictions to the use of montelukast in allergic rhinitis. In Jul 2020, Health Canada adopted similar measures as the FDA. In the United Kingdom, montelukast is only indicated for symptomatic relief of seasonal allergic rhinitis in patients with asthma.
HSA has received a small number of reports of neuropsychiatric events associated with the use of montelukast since its registration in Singapore in 1998. The events include aggressive behaviour, agitation, depression, tremor, hallucinations, hyperactivity, and sleep disturbances such as somnolence, insomnia and nightmares. There were no reports received for suicidal behaviour. The use of concomitant medicines and/or presence of comorbidities were not reported for most cases, limiting firm causality assessment.
HSA’s benefit-risk assessment took into consideration the local safety data, current international clinical practice guidelines on the treatment of allergic rhinitis and asthma, the availability of alternative treatments for allergic rhinitis, inputs from local clinicians (including respiratory specialists, general practitioners and psychiatrists) and international regulatory actions. Based on currently available information, HSA, in consultation with its Product Vigilance Advisory Committee, has concluded that the benefit-risk profile of montelukast remains favourable for its approved indications, if additional precautionary measures are taken to mitigate the risk of neuropsychiatric events. These additional measures include restricting the use in allergic rhinitis to patients who are inadequately treated or intolerant to alternative therapies and the strengthening of warnings on neuropsychiatric events in the package inserts of products containing montelukast.
Healthcare professionals are advised of the following, when considering the use of montelukast:
- To consider the benefits of treatment with montelukast and its risks of neuropsychiatric effects before prescribing montelukast.
- To discuss with their patients and/or caregivers on the benefits and risks of treatment when prescribing montelukast. Healthcare professionals may make use of the patient educational material available for montelukast for patient counselling.
- To advise their patients and/or caregivers to be alert to changes in behaviour or new neuropsychiatric symptoms when taking montelukast and to seek medical attention if neuropsychiatric symptoms occur.
HSA has issued a Dear Healthcare Professional Letter on 30 Oct 2020 to inform healthcare professionals of the advisory on the new restriction on montelukast use and neuropsychiatric events. HSA is working with the product registrants of montelukast-containing products to update the local PIs with the new recommendations on the indicated use of montelukast in allergic rhinitis and additional safety information on the risk of neuropsychiatric adverse events.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/safety-alert/advisory-on-restriction-on-the-use-of-montelukast-and-neuropsychiatric-effects
In Hong Kong, there are 50 registered pharmaceutical products containing montelukast, and all products are prescription-only medicines. So far, the Department of Health (DH) has received 3 cases of adverse drug reaction related to montelukast, of which one case is related to neuropsychiatric events.
Related news 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 31 Oct 2020. Letters to inform local healthcare professionals were issued by the DH on 20 Sep 2019 and 5 Mar 2020.
In Feb 2020, the Registration Committee of the Pharmacy and Poisons Board discussed the risk of neuropsychiatric reactions of montelukast, including speech impairment and obsessive-compulsive symptoms, and decided to remain vigilant on any related safety updates by other overseas drug regulatory authorities on this issue.
Regarding the restriction on the use of montelukast and the strengthening of warnings on neuropsychiatric risks, as previously reported, the matter will be further discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Dec 11, 2020
Issued at HKT 16:00
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