氣喘藥改變行為 美發布警訊
【聯合報╱記者施靜茹／台北報導】 2008.03.29 02:12 am
常見的氣喘治療藥物「欣流」（藥品名Singulair，成分名Montelukast），美國ＦＤＡ(食品暨藥物管理局)昨天發布用藥警訊，提醒可能導致使用者行為改變，甚至有自殺意念。
國內代理此藥的默沙東藥廠指出，此藥全球的使用者高達數百萬人，去年9月起，在國內仿單（說明書）加註警語，目前台灣並未接到不良反應通報，只有一些患者表示服藥後，出現腹痛、頭暈、皮膚疹等症狀，但不能證實與服藥有關。
長庚兒童醫院兒童內科部部長黃璟隆說，國內約有三分之一小兒氣喘病人都使用此藥，它屬於抑制發炎用藥，由於有咀嚼錠，小朋友接受度高，常取代吸入型類固醇，「曾有小病人一個晚上偷吃2、30顆，還好沒發生副作用」。
衛生署藥政處表示，該藥在2000年取得國內藥證，2001年上市，目前發出張藥證，適應證為預防及長期治療成人和小兒氣喘，仿單註明「曾有病患服用後出現夢境異常、幻覺、昏昏欲睡、頭暈、心理性肌肉運動，過度活躍，包括易怒、躁動、侵略性行為、坐立不安、顫抖、沮喪，甚至自殺想法和行為」。
衛生署提醒，萬一病患服此藥導致不良反應，可洽詢全國藥物不良反應通報中心，專線02-2396-0100，網站 http://adr.doh.gov.tw。
【2008/03/29 聯合報】@ http://udn.com/
氣喘藥改變行為 美發布警訊
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sheepin
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Re: 氣喘藥改變行為 美發布警訊
我真的有遇過因為使用呼吸道的藥物使用到被誤以為是精神科患者
（我遇到的案例不是使用Singulair）
弄到住進精神科病房
症狀嚴重到我們一開始的impression是psychotic depression
結果最後把藥全都停了，就好了
（我遇到的案例不是使用Singulair）
弄到住進精神科病房
症狀嚴重到我們一開始的impression是psychotic depression
結果最後把藥全都停了，就好了
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joelin
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Re: 氣喘藥改變行為 美發布警訊
steroid (?愛麗絲夢遊)
antihistamin (anticholinergic effect): 尤其是 periactin ..
也有遇到 ~~~
antihistamin (anticholinergic effect): 尤其是 periactin ..
也有遇到 ~~~
儒 學 身 能
道 修 靈 淨
佛 悟 心 空
道 修 靈 淨
佛 悟 心 空
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銀色大道
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Re: 氣喘藥改變行為 美發布警訊
Asthma Medication Evaluated for Possible Link to Behavior/Mood Changes and Suicidality
March 27, 2008 — The US Food and Drug Administration (FDA) has issued a MedWatch safety alert informing doctors and patients that it is investigating a possible link between use of montelukast (Singulair, Merck) and changes in mood and behavior as well as suicidality and suicide.
The drug, a leukotriene-receptor antagonist, is indicated for the treatment of asthma and symptoms of allergic rhinitis and to prevent exercise-induced asthma.
The agency is working with Merck to evaluate the possible link in response to inquiries it has received, the alert notes, and has asked Merck to review its study data for more information about suicidality and suicide.
"Due to the complexity of the analyses, the FDA anticipates that it may take up to 9 months to complete the ongoing evaluations," the alert notes. "As soon as this review is complete, the FDA will communicate the conclusions and recommendations to the public."
The statement emphasizes, though, that "posting this information does not mean that the FDA has concluded there is a causal relationship between the drug product and the emerging safety issue. Nor does it mean that the FDA is advising healthcare professionals to discontinue prescribing this product. The FDA is considering but has not reached a conclusion about whether this information warrants any regulatory action."
Over the past year, Merck has updated the prescribing and patient information on montelukast to include a number of adverse events found in postmarketing surveillance, including tremor, depression, suicidality, and anxiousness, the alert notes. In February 2008, the FDA and Merck discussed how best to communicate these changes, including face-to-face interactions with prescribers and provision of patient-information leaflets.
Patients should not stop taking montelukast before talking to their doctor about the new information, the alert adds. Healthcare professionals and caregivers are encouraged to monitor patients for any of these changes.
The FDA is also reviewing postmarketing reports of behavior/mood changes, suicidality, and suicide in other leukotriene-modifying medications, including zafirlukast (Accolate, AstraZeneca), also a leukotriene-receptor antagonist, and zileuton (Zyflo and Zyflo CR, Critical Therapeutics), a leukotriene-synthesis inhibitor, and plans to assess whether further investigation is warranted.
The agency urges healthcare professionals and patients to report adverse effects from use of any of these agents to the MedWatch Adverse Event Reporting System.
http://www.medscape.com/viewarticle/572 ... &src=nldne
March 27, 2008 — The US Food and Drug Administration (FDA) has issued a MedWatch safety alert informing doctors and patients that it is investigating a possible link between use of montelukast (Singulair, Merck) and changes in mood and behavior as well as suicidality and suicide.
The drug, a leukotriene-receptor antagonist, is indicated for the treatment of asthma and symptoms of allergic rhinitis and to prevent exercise-induced asthma.
The agency is working with Merck to evaluate the possible link in response to inquiries it has received, the alert notes, and has asked Merck to review its study data for more information about suicidality and suicide.
"Due to the complexity of the analyses, the FDA anticipates that it may take up to 9 months to complete the ongoing evaluations," the alert notes. "As soon as this review is complete, the FDA will communicate the conclusions and recommendations to the public."
The statement emphasizes, though, that "posting this information does not mean that the FDA has concluded there is a causal relationship between the drug product and the emerging safety issue. Nor does it mean that the FDA is advising healthcare professionals to discontinue prescribing this product. The FDA is considering but has not reached a conclusion about whether this information warrants any regulatory action."
Over the past year, Merck has updated the prescribing and patient information on montelukast to include a number of adverse events found in postmarketing surveillance, including tremor, depression, suicidality, and anxiousness, the alert notes. In February 2008, the FDA and Merck discussed how best to communicate these changes, including face-to-face interactions with prescribers and provision of patient-information leaflets.
Patients should not stop taking montelukast before talking to their doctor about the new information, the alert adds. Healthcare professionals and caregivers are encouraged to monitor patients for any of these changes.
The FDA is also reviewing postmarketing reports of behavior/mood changes, suicidality, and suicide in other leukotriene-modifying medications, including zafirlukast (Accolate, AstraZeneca), also a leukotriene-receptor antagonist, and zileuton (Zyflo and Zyflo CR, Critical Therapeutics), a leukotriene-synthesis inhibitor, and plans to assess whether further investigation is warranted.
The agency urges healthcare professionals and patients to report adverse effects from use of any of these agents to the MedWatch Adverse Event Reporting System.
http://www.medscape.com/viewarticle/572 ... &src=nldne