狀, 或有其它原因無法使用其他藥物治療之情形, 且處方藥品前應詳細告知病人於懷孕期間使用該藥品的相關風險 3. 醫師處方該類成分藥品於正值生育年齡之女性病人前, 應確定病人並未懷孕, 並告知在用藥期間應有效避孕 4. 對於有計劃懷孕的婦女, 應告知使用該藥品之風險與治療效益, 並考慮使用其他替代療法

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1 Valproate 相關成分藥品安全資訊風險溝通表藥品成分藥品名稱及許可證字號適應症藥理作用機轉訊息緣由藥品安全有關資訊分析及描述製表日期 :106/10 Valproate ( 包括 valproate sodium divalproex sodium valproic acid) 衛生福利部核准含 valpraote 相關成分藥品製劑許可證共 35 張查詢網址 : 癲癇大發作小發作混合型及顳葉癲癇躁症或急性躁期之躁鬱症之治療偏頭痛之預防提升腦內抑制性物質 GABA 的濃度, 進而抑制神經傳導物質的釋放並降低突觸後神經元之作用歐洲醫藥管理局 (EMA) 近期將重新衡量 valproate 相關成分藥品用於懷孕及育齡婦女之安全性及目前風險管控措施之成效, 以評估是否需採取更進一步之作為 EMA 網址 : rrals/valproate_and_related_substances/human_referral_prac_ jsp& mid=wc0b01ac05805c516f EMA 於 2014 年經評估認為母體孕期暴露於 valproate 相關成分藥品的嬰孩有發生畸胎或發展異常等風險, 故採取加強警語及限縮使用等風險管理措施現法國醫藥監管單位 (ANSM) 請 EMA 評估目前風險管理措施的成效, 並衡量是否需採取更進一步之作為食品藥物管理署說明 : 1. 我國已於 102 年重新評估 valproate 相關成分藥品使用於孕婦之臨床效益及風險, 並於 102 年 9 月 24 日以部授食字第 A 號公告再評估結果, 包括限縮該成分藥品之使用, 禁止使用於懷孕婦女偏頭痛之預防, 於其他適應症的懷孕婦女, 亦僅限用於無法使用其他藥物治療之情形, 並要求中文仿食品藥物管理署風險溝通說明單加刊有關先天性畸形風險之相關警語及注意事項, 以提醒民眾及醫療人員注意 2. 本署將評估我國現行風險管控措施之成效, 以評估是否須採取更進一步之作為醫療人員應注意事項 : 1. Valproate 相關成分藥品使用於孕婦, 可能會導致重大先天性畸形, 特別是神經管畸形, 且可能會導致胎兒智商下降 2. Valproate 相關成分藥品禁止使用於懷孕婦女偏頭痛之預防, 於其他適應症的懷孕婦女, 亦僅限用於無法以其他藥物控制症

2 狀, 或有其它原因無法使用其他藥物治療之情形, 且處方藥品前應詳細告知病人於懷孕期間使用該藥品的相關風險 3. 醫師處方該類成分藥品於正值生育年齡之女性病人前, 應確定病人並未懷孕, 並告知在用藥期間應有效避孕 4. 對於有計劃懷孕的婦女, 應告知使用該藥品之風險與治療效益, 並考慮使用其他替代療法 5. 對於使用該藥之女性病人及進入青春期女童, 須定期追蹤治療情形, 並評估使用該藥之臨床效益用藥病人應注意事項 : 1. 未與醫師諮詢前, 請勿自行停用 valproate 相關成分藥品, 以避免造成對您或胎兒之傷害 2. 正值生育年齡之女性病人, 應諮詢專業醫療人員, 採行有效之避孕措施如發現可能懷孕或計畫懷孕, 請立即告知您的醫師您的醫師將會重新評估對您的治療 3. 如您對您的治療計畫或避孕措施有疑問, 請諮詢您的醫師或藥師醫療人員或病人懷疑因為使用 ( 服用 ) 藥品導致不良反應發生時, 請立即通報給衛生福利部所建置之全國藥物不良反應通報中心, 並副知所屬廠商, 藥物不良反應通報專線 , 網站 : 衛生福利部食品藥物管理署獲知藥品安全訊息時, 均會蒐集彙整相關資料進行評估, 並對於新增之藥品風險採取對應之風險管控措施

3 人... 信JLEU,旬,路叫地承電傳電受文者 : 各縣市醫師公會址辨話真子n叫號台oo-司 j /.nu--ahvoo穿1(( 咚Xυnru 的J3nxυM布H竹 oomlu--+l mn凹ulh才... 樓檔號. 係存年限 : 中華民國醫師公會全國聯合會函 n邁u阿nnv唔,, nl諦,心r i甘刊可t 同內nLGAva仇"υrnbηru4L4才#鴨",a whb1 E縛,n"υ發文日期 : 中華民國 102 年 10 月 3 日發文字號 : 全醫聯字第號途別 : 普通件密等及解密條件或保密期限 : 附件 : 如文主話 : 轉知衛生福利部 102 年 9 月 24 日部授食字第 A 號公告含 valproate 相關成分 Cvalproate sodium, divalproex sodium, valproic acid) 藥品仿單修訂相關事宜 ( 如附件 ) 請查照說明 : 訂一依衛生福利部 102 年 9 月 24 日部授食字第 B 號函副本辦理二告揭成分藥品, 經該部彙集圍內外相關資料及臨床相關文獻報告進行整體性評估, 評估結果為 : ( 一 ) Valproate 相關成分 C valproate sodium, divalproex sodium, valproic acid) 且適應症未含偏頭痛之預防綠之藥品, 其中文仿單刊載事項如公告附件 1 ( 二 ) Valproate 相關成分 C valproate sodi um, divalproex sodium, valproic acid) 且適應症含偏頭痛之預防之藥品, 其中文仿單刊載事項如公告附件 2 三本訊息刊登台灣醫界雜誌及本會網站寄至已右 t

10 March 2017 EMA/144306/2017 New review of valproate use in pregnancy and women of childbearing age EMA to consider if risks of these medicines require further restrictions of use The European

13 10 March 2017 EMA/144306/2017 New review of valproate use in pregnancy and women of childbearing age EMA to consider if risks of these medicines require further restrictions of use The European Medicines Agency (EMA) has started a review looking at the use of valproate-containing medicines in the treatment of women and girls who are pregnant or of childbearing age. These medicines are approved nationally in the EU to treat epilepsy, bipolar disorder and in some countries, migraine, and have been previously reviewed by the Agency. An EMA review in resulted in measures to strengthen the warnings and restrictions on the use of valproate medicines in women and girls, due to the risk of malformations and developmental problems in babies who are exposed to valproate in the womb. Although sometimes there may be no alternative to using valproate, these measures aimed to ensure that patients are aware of the risks of doing so, and that they take valproate only when clearly necessary. The 2014 review also recommended studies at EU level to measure how effective the proposed measures were. Some EU member states have since carried out additional assessments of the impact of the measures at national level and concerns have been raised about how effective the measures have been in increasing awareness and reducing valproate use appropriately in its various indications. The French medicines regulator, ANSM, therefore asked EMA to review the effectiveness of the measures and to consider whether further EU-wide action should be recommended to minimise the risks in women who are pregnant or of childbearing age. EMA s Pharmacovigilance Risk Assessment Committee (PRAC) will examine the available evidence and will consult with relevant stakeholder groups. This will include holding a public hearing about their concerns. While the review is ongoing, patients prescribed valproate who have any concerns about their medication should discuss them with their healthcare professionals. More about the medicine Valproate medicines are used to treat epilepsy and bipolar disorder. In some EU Member States they are also authorised to prevent migraine headaches. 1 man_referral_prac_ jsp&mid=wc0b01ac05805c516f 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.

14 The active ingredient in these medicines may be valproic acid, magnesium valproate, sodium valproate, valproate semisodium or valpromide. Valproate medicines have been authorised via national procedures in all EU Member States and in Norway and Iceland. They are marketed under several brand names including: Absenor, Convival Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Kentlim, Leptilan, Micropakine L.P., Orfiril, Petilin, Valepil, Valhel PR, Valpal, Valpro and Valprolek. More about the procedure The review of valproate was initiated on 9 March 2017 at the request of the French medicines regulator ANSM, under Article 31 of Directive 2001/83/EC. The review will be carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations. The PRAC recommendations will then be sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures Human (CMDh), which will adopt a position. The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway. It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU. Contact our press officer Monika Benstetter Tel. +44 (0) press@ema.europa.eu New review of valproate use in pregnancy and women of childbearing age EMA/144306/2017 Page 2/2

國立中山大學學位論文典藏.PDF

國立中山大學學位論文典藏.PDF I II III The Study of Factors to the Failure or Success of Applying to Holding International Sport Games Abstract For years, holding international sport games has been Taiwan s goal and we are on the way