Singulair (montelukast) and All Montelukast Generics:
Strengthened Boxed Warning - Due to Restricting Use for Allergic Rhinitis (1)
[Posted 03/04/2020]
AUDIENCE: Patient, Health Professional, Pharmacy, Allergy and Immunology
ISSUE: FDA is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair and generics), which is a prescription medicine for asthma and allergy.
We are taking this action after a review of available information led us to reevaluate the benefits and risks of montelukast use. Montelukast prescribing information already includes warnings about mental health side effects, including suicidal thoughts or actions; however, many health care professionals and patients/caregivers are not aware of the risk. We decided a stronger warning is needed after conducting an extensive review of available information and convening a panel of outside experts, and therefore determined that a Boxed Warning was appropriate.
BACKGROUND: Montelukast is FDA-approved for asthma and allergies. It is a prescription medicine approved to prevent asthma attacks and for the long-term treatment of asthma in adults and children 1 year and older. It is approved to prevent exercise-induced asthma in patients 6 years and older. Montelukast is also approved to control the symptoms of allergic rhinitis, also known as hay fever, such as sneezing, stuffy nose, runny nose, and itching of the nose. It is used to treat seasonal outdoor allergies in patients 2 years and older, and year-round indoor allergies in patients 6 months and older.
RECOMMENDATION:
Patients should talk with your health care professional about:
• the benefits and risks of montelukast, as many other safe and effective allergy medicines are widely available.
• any history of mental illness before starting treatment.
美國FDA加強發布使用治療氣喘或過敏的藥品montelukast（Singulair和其學名藥）有關嚴重行為和與情緒相關的變化的藥物安全警訊。
Montelukast為處方藥，經美國FDA核准用於氣喘和過敏，包含：預防氣喘發作和長期治療1歲以上兒童和成人的氣喘、預防6歲以上病人因運動引起的氣喘、控制過敏性鼻炎（亦被稱為花粉症）的症狀，例如打噴嚏、鼻塞、流鼻水和鼻子癢；此藥亦可用於治療2歲以上病人的季節性戶外相關過敏，以及6個月以上的病人全年室內相關的過敏。
美國FDA回顧現有證據和資訊後，重新評估使用montelukast的益處和風險。Montelukast的仿單已包含有關心理健康相關副作用的警訊，包括自殺念頭或行為；然而，許多醫療專業人員/病人和其照顧者並未意識到此風險。在對現有證據和資訊進行廣泛審查並召集外部專家小組座談會後，美國FDA決定有必要於仿單以「加框警語」警示，以加強警示此副作用的風險。
病人應與醫療專業人員討論：
• Montelukast的益處和風險，因為尚有許多其他安全有效的抗過敏藥物。
• 開始治療前是否有精神病相關病史。
更多相關訊息與連結請參考FDA網址：
https://reurl.cc/D9o6ME
（待續）
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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