Singulair (montelukast) and All Montelukast Generics:
Strengthened Boxed Warning - Due to Restricting Use for Allergic Rhinitis (2)
[Posted 03/04/2020]
AUDIENCE: Patient, Health Professional, Pharmacy, Allergy and Immunology
Health Professionals should:
• Ask patients about any history of psychiatric illness prior to initiating treatment.
• Consider the risks and benefits of montelukast when deciding to prescribe or continue patients on the medicine.
• Advise all patients of the risk of neuropsychiatric events when prescribing montelukast. Warnings about these side effects are included in the existing prescribing information.
• Advise patients and parents/caregivers that the patient should stop taking montelukast and contact a health care professional immediately if changes in behavior or new neuropsychiatric symptoms, suicidal thoughts or behavior occur.
• Monitor all patients treated with montelukast for neuropsychiatric symptoms. Events have occurred in patients with and without pre-existing psychiatric disease.
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/safety/medical-product-safety-information/singulair-montelukast-and-all-montelukast-generics-strengthened-boxed-warning-due-restricting-use?utm_campaign=FDA%20MedWatch%20Singulair%20%28montelukast%29%3A%20Strengthened%20Boxed%20Warning&utm_medium=email&utm_source=Eloqua
醫療專業人員應：
• 開始治療前，請詢問病人是否有精神病相關病史。
• 在決定須新開立或繼續服用montelukast時，應考慮此藥的風險和益處。
• 仿單中已包含神經或精神相關副作用的警訊，處方montelukast時，應提醒所有病人注意相關副作用。
• 建議病人和家長/照顧者，若病人行為發生變化或出現新的神經精神相關症狀、自殺念頭或行為，應停止服用montelukast並立即聯繫醫療專業人員。
• 監測所有接受montelukast治療的病人有無神經精神相關症狀，因無論先前是否有精神相關病史的病人皆有可能出現此風險。
更多相關訊息與連結請參考FDA網址：https://reurl.cc/D9o6ME
（全文完）
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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