临床药讯电子版09年第5期.pdfVIP

2009 年第 5 期 · 总第 17 期 本 期 目 录 药事动态 SFDA 修订国内盐酸吡格列酮制剂说明书 ········································································1· SFDA 发布 2009 年第 1 期国家药品质量公告 ··································································2· 合理用药 合理使用水溶性维生素 ········································································································3· 规范氟喹诺酮类药物的临床应用 ························································································4· 骨质疏松药为何致骨坏死 ····································································································5· 手术前停药有讲究 ················································································································7· ADR 之窗 丙硫氧嘧啶可能造成严重肝损害 ························································································8· 近期《药品不良反应信息通报》要点解读 ········································································9· 药物咨询与分析 药物不合理应用分析 4 例 ··································································································14· 临床药讯电子版 2009 年第 5 期 药事动态 SFDA 修订国内盐酸吡格列酮制剂说明书 2009 年 4 月 2 日，国家食品药品监督管理局（ SFDA ）发布《关于修订国内盐酸吡 格列酮制剂说明书的通知》。《通知》称，为控制盐酸吡格列酮制剂的使用风险，保护 患者用药安全，国家食品药品监督管理局决定对盐酸吡格列酮制剂的说明书进行修订。 现将有关事项通知如下： 一、在盐酸吡格列酮制剂说明书中增加心血管风险的黑框警告，增加骨折、黄斑水 肿等安全性风险信息。 二、请通知辖区内药品生产企业尽快修订说明书和标签，并将修订的内容及时通知 相关医疗机构、药品经营企业等单位。相关药品生产企业还应主动跟踪该类药品临床应 用的安全性情况，按规定收集不良反应并及时报告。 附件：盐酸吡格列酮制剂说明书增加的安全性信息内容 1. 在说明书的顶端增加以下黑框警告内容： 警告：充血性心力衰竭 噻唑烷二酮类药物，包括吡格列酮，在某些患者中有导致或加重充血性心衰的危 险（参见［注意事项］）。开始使用本品和用药剂量增加时，应严密监测患者心衰的 症状和体征（包括体重异常快速增加、呼吸困难和／或水肿）。如果出现上述症状和 体征，应按照标准心衰治疗方案进行处理，而且必须停止本品的应用或减少剂量。心 衰患者禁止使用本品。