關於國際藥物管理當局對於精神科藥物的警告（2005） - 趣味新聞網

發表日期 2017-04-22T00:59:09+08:00

     關於國際藥物管理當局對於精神科藥物的警告（2005）

2005:April: The FDA warned that the use of antipsychotic drugs in elderly patients with dementia could place them at increased risk of death.  It required manufacturers to add a “boxed warning” to this effect on drug packaging.四月：美國食品藥物管理局警告：給有失智的老人使用抗精神藥，可能會增加死亡的危險。它要求廠商加上這種效應的警語在藥物包裝上。August: The Australian TGA reported that SSRI antidepressants could cause “new onset of suicidality” in adults and also agitation, nervousness and anxiety. Similar symptoms could occur during withdrawal. 八月： 澳洲的TGA（治療性商品管理局）報導SSRI（選擇性血清素迴收抑製劑）抗憂鬱劑可能造成成人新發生的自殺，也包含躁動，神經質以及焦慮。類似的癥狀可能發生在戒斷時。  August: The European Medicines Agency’s Committee for Medicinal Products issued its strongest warning against pediatric use of antidepressants, stating they could cause suicide attempts and thoughts, aggression, hostility and oppositional behavior and anger. 八月：歐洲藥用産品醫學服務機構委員會發佈小兒科使用抗憂鬱劑最強烈的警告，提到他們可能造成自殺企圖及想法，攻擊性，敵意以及對抗性的行為與憤怒。 September:  The Australian TGA warned that antidepressant use during pregnancy could cause “withdrawal effects” in infants “that can be severe or life-threatening.” The FDA issued a warning the drugs when taken during pregnancy could increase the risk of major birth defects, including heart malformations in newborns.  Health Canada followed with a similar warning in December. 九月：澳洲的TGA治療性商品管理局懷孕時使用抗憂鬱劑可能造成嬰兒的戒斷反應，反應可能變嚴重甚至會威脅生命。美國食品藥物管理局公佈這種藥物的警告：當懷孕時服用可能增加重大齣生缺陷的危險性包含新生兒的心髒畸形。加拿大健康局接著在十二月也有類似的警告。September:  The Agenzia Italiana del Farmaco (Italian drug regulatory agency) ordered a warning label for older type antidepressants that they also should not be prescribed for under 18 year olds and that the drugs were associated with heart attacks in people of any age.  義大利藥物管理局針對傳統抗憂鬱劑要求一個警告性的標簽：它們不應開給18歲以下的人而且任何年紀人服用，它們都可能會心髒病發。October: The FDA withdrew the stimulant Cylert from the market because of its “overall risk of liver toxicity” and liver failure. 十月：美國食品藥物管理局把興奮劑Cybert從市場下架，因其肝髒的整體毒性以及肝衰竭之作用。  October: The FDA ordered an additional warning to the packaging of the antidepressant Cymbalta that it could cause liver damage. 十月： 美國食品藥物管理局要求一個附加性的警語在抗憂鬱劑韆憂解（Cymbalta)的包裝上，它可能導緻肝損害。  November:  The FDA approved updated labeling for the antidepressant Effexor ER (extended release), to note it could cause homicidal ideation. 十一月：美國食品藥物管理局核準瞭一個對抗憂鬱劑速悅持續性藥效膠囊（Effexor ER)最新標簽，註記它可能導緻殺人的想法。 December:  Health Canada warned that pregnant women taking Paxil placed their newborn at risk of birth defects. 十二月：加拿大健康局警告懷孕婦女服用剋憂果（Paxil)會讓她們的新生兒有齣生缺陷的危險。

文章來源： 鄭醫師

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