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国家食药监局提醒关注双膦酸盐药物安全性问题
发布时间：2011-04-18      来源：中新网
    据国家食品药品监督管理局网站消息，国家药品不良反应监测中心日前发布第37期《药品不良反应信息通报》，通报了双膦酸盐药物的严重不良反应。国家食药监局提醒广大医务人员、公众和药品生产企业关注双膦酸盐药物安全性问题，警惕相关风险。

　　双膦酸盐药物主要用于治疗骨质疏松症、恶性肿瘤骨转移及高钙血症等疾病的治疗。

　　2005年开始，美国、英国、加拿大等药品监管局相继发布了双膦酸盐药物的安全性信息以及修改相关药品说明书的建议。安全性信息主要包括使用双膦酸盐药物后患者出现颌骨坏死、严重肌肉骨骼痛、食管癌以及肾功能衰竭等。

　　截至2011年2月底，国家药品不良反应监测中心共收到双膦酸盐药物相关不良反应报告1072例。主要不良反应包括发热、呕吐、皮疹、腹泻、头晕、腹痛、肌肉骨骼痛、疼痛、头痛、过敏样反应、胸痛、流感样症状、溃疡性口炎、低钙血症、心悸、厌食、消化不良、水肿、眼部症状等。其中骨骼肌肉损害191例次、食道损害53例次、肾功能损害20例次、下颌骨损害病例3例次。

　　国家食品药品监督管理局建议临床医生在使用双膦酸盐药物时密切监护患者健康状况，应针对患者不同状况调整治疗方案，避免或减少不良后果的发生。建议生产企业及时完善产品说明书；加强药品安全用药的宣传，详细全面的告知药品安全性信息；实施主动监测，收集品种不良反应信息，针对不同品种制定不同的风险管理计划，最大程度的保障患者的用药安全。

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