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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The Health Sciences Authority (HSA), in consultation with its Product Vigilance Advisory Committee (PVAC), would like to inform healthcare professionals of the new restriction on the use of montelukast due to the risk of neuropsychiatric events. This follows HSA’s benefit-risk assessment of montelukast which concluded that the benefits of montelukast for use in allergic rhinitis patients remain favourable 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.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/advisory-on-restriction-on-the-use-of-montelukast-and-neuropsychiatric-effects
In Hong Kong, there are 52 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 5 Mar 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/Saturday, Oct 31, 2020
Issued at HKT 13:00
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