Risk of serious neuropsychiatric events with montelukast
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Risk of serious neuropsychiatric events with montelukast Safety labelling updates in the Canadian product monograph for montelukast [Singulair] were referred to in a recent Health Product InfoWatch, regarding the risk of serious neuropsychiatric events. The reported event types included aggression, agitation, depression, sleep disturbances, and suicidal thoughts or behaviour. Such events have been reported in patients with and without a history of psychiatric disorders, both during montelukast treatment and after drug withdrawal. The risk of neuropsychiatric events has been included in the Serious Warnings and Precautions box of the drug monograph, and the Warnings and Precautions, Adverse Reactions, Dosage and Administration, and Consumer Information sections have been updated. In some patients, montelukast benefits may not outweigh the risks. Use should be reserved for patients who have an inadequate response or intolerance to alternative therapies. Healthcare professionals should advise their patients and/ or caregivers to be alert for behaviour changes, and to discontinue montelukast and seek guidance if changes are observed. Health Canada. PRODUCT MONOGRAPH UPDATES - Singulair (montelukast). Health Product InfoWatch : Aug 2020. Available from: URL: https://www.canada.ca/ 803500770 content/dam/hc-sc/documents/services/drugs-health-products/medeffect-canada/health-product-infowatch/august-2020/hpiw-ivps-eng.pdf
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Reactions 12 Sep 2020 No. 1821
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