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Advisory on restriction on the use of montelukast and neuropsychiatric effects

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 (PIs) 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 letter for details.
Healthcare professional, Industry member, Therapeutic Products
Published:

Dear Healthcare Professional Letters

30 Oct 2020

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.moh.gov.sg/hpp/, and follow the procedures below to access the MOH Alert system.

Step 1: On the top navigation ribbon of webpage, select 'For Healthcare Professionals' followed by 'Health Professionals Portal' and click on the choice of profession. User will be redirected to the specific HPP webpage for the selected profession.

Step 2: Click on the Restricted Content icon on the left panel of webpage and login via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’ section

Step 4: Click on the Drug Alert tab to view the DHCPLs.