里素劳撤市原因及对风险管理的思考

中国药物警戒 ›› 2014, Vol. 11 ›› Issue (9): 550-553.

里素劳撤市原因及对风险管理的思考

王丹¹, 吴桂芝¹, 聂晓璐²

1国家食品药品监督管理局药品评价中心, 北京 100045;
2北京儿童医院,北京 100049

收稿日期:2014-05-05 修回日期:2016-02-03 出版日期:2014-09-08 发布日期:2016-03-02
作者简介:王丹,女,副主任药师,药品不良反应监测与评价。

Reasons for Nizoral Withdrawal from the Market and Reflections on Risk Management

WANG Dan¹, WU Gui-zhi¹, NIE Xiao-lu²

1Center for Drug Reevaluation, CFDA, Beijing 100045, China;
2Beijing Children's Hospital, Beijing 100049, China

Received:2014-05-05 Revised:2016-02-03 Online:2014-09-08 Published:2016-03-02

摘要/Abstract

摘要： 通过梳理酮康唑近年来国内外监管动态,从药品不良反应、临床使用情况、药品的治疗地位、风险管理以及药品受益-风险平衡等方面系统分析了里素劳（酮康唑片）的撤市原因,为进一步阐明药品的市场淘汰机制以及风险管理在药品生命周期中的作用提供了参考案例。

关键词: 酮康唑, 里素劳, 酮康唑片, 撤市

Abstract: This article reviews the recent domestic and international activities of ketoconazole regulation, analyzes systematically the reasons of Nizoral (ketoconazole tablets) withdrawal from aspects of drug adverse reaction, clinical usage, risk management and benefit-risk balance, and provides a reference case to further elucidates the mechanism of drugs out of market and the role of risk management in the drug life cycle.

Key words: ketoconazole, Nizoral, ketoconazole tablets, withdrawal

中图分类号:

王丹, 吴桂芝, 聂晓璐. 里素劳撤市原因及对风险管理的思考[J]. 中国药物警戒, 2014, 11(9): 550-553.

WANG Dan, WU Gui-zhi, NIE Xiao-lu. Reasons for Nizoral Withdrawal from the Market and Reflections on Risk Management[J]. Chinese Journal of Pharmacovigilance, 2014, 11(9): 550-553.

参考文献

[1] CFDA. 食品药品监管总局办公厅关于注销酮康唑片药品批准文号的通知[EB/OL] . (2013-12-25) [2014-7-29].http://www.sfda.gov.cn/WS01/CL0844/95616.html.
[2] AFSSAPS. Recall of specialty Nizoral 200 mg tablet [EB/OL].（2011-07-11）[2014-08-01]. http://www.ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/Rappel-de-la-specialite-NIZRAL-200-mg-comprime.
[3] EMA. European Medicines Agency recommends suspension of marketing authorisations for oral ketoconazole[EB/OL].（2013-07-26）[2014-07-29]. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/07/news_detail_001855.jsp&mid=WC0b01ac058004d5c1.
[4] FDA. FDA Drug Safety Communication: FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems[EB/OL].（2013-07-26）[2014-07-29]. http://www.fda.gov/drugs/drugsafety/ucm362415.htm.
[5] 王高松. 临床真菌病学[M]. 上海：复旦大学出版社,1986：346-347.
[6] AFSSAPS. Authorization commission on the drugs(Meeting No. 494 of January 27,2011)[EB/OL].（2011-07-26）[2014-08-01].http://www.ansm.sante.fr/var/ansm_site/storage/original/application/25355bbfb399cca5ac0cf56d0a308477.pdf.
[7] 陶庆梅, 聂晓璐,程刚,等. 酮康唑口服制剂不良反应总体情况及肝损害发生率系统综述[J]. 中国药物警戒,2013,10（12）:719-722.
[8] 聂晓璐,陶庆梅,詹思延,等.酮康唑口服制剂致肝损害风险因素的系统评价[J]. 中国药物警戒,2012,9(8):460-463.
[9] García Rodríguez L. A., Duque A., Castellsague J., Pérez-Gutthann S. & Stricker B. H. C. A cohort study on the risk of acute liver injury among users of ketoconazole and other antifungal drugs[J]. Br J Clin Pharmacol,1999,48(6): 847-852.
[10] 杜晓曦,张承绪,郭惠普,等.药品不良反应监测与监管[M]. 中国医药科技出版社,2013:91-92.
[11] 国家药品不良反应信息中心. 药品不良反应信息通报（第40期）：警惕酮康唑口服制剂的严重肝毒性 [EB/OL].（2013-07-26）[2014-09-03] . http://www.cdr.gov.cn/xxtb_255/ypblfyxxtb/201109/t20110908_3290.html.