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中药注射液再涉不良反应 明星产品被勒令停用召回

2017-09-25 07:26:54   中国经济网

9月23日,国家食药监总局发布了《关于山西振东安特生物制药有限公司红花注射液和江西青峰药业有限公司喜炎平注射液质量问题的通告》,这两家公司生产的药品因存在不良反应,被勒令停止使用。监管部门要求这两家公司立即召回相关批号产品。

据记者了解,喜炎平注射液、红花注射液曾被监管部门提示警惕其存在的不良反应。

来自东吴证券的分析报告认为,未来中药注射剂市场将进一步收缩,产品质量将成为决胜关键。

一位医药行业分析人士向记者表示,在监管部门下令彻查此事之际,两家公司的产品销售或受影响。值得一提的是,喜炎平注射液在清热解毒类中药注射液销售领域领先,可谓是明星产品。

再涉不良反应

国家食药监总局公布的信息显示,2017年8月底,国家药品不良反应监测中心监测发现,山西振东安特生物制药有限公司生产的红花注射液(批号:20170404)在山东、新疆等地发生10例寒战、发热等不良反应。9月22日,经山东省食品药品检验研究院检验,该批次药品热原不符合规定。

此外,国家药品不良反应监测中心监测发现,江西青峰药业有限公司生产的三种不同批号的喜炎平注射液在甘肃、黑龙江、江苏共发生十多例寒战、发热等严重不良反应。事发地食品药品监管部门对涉事产品正在检验。

目前,山西振东安特生物制药有限公司生产的涉事批次红花注射液共销往山西、江苏等10省(区)。江西青峰药业有限公司生产的涉事批次喜炎平注射液共销往北京、天津、河北等28省(区、市)。

国家食药监总局要求所有医疗机构立即停止使用上述批号产品,责令山西振东安特生物制药有限公司、江西青峰药业有限公司立即召回上述批号产品。山西、江西省食品药品监督管理局要监督企业停止涉事品种的销售,确保药品全部召回。药品流入地的省(区、市)食品药品监督管理部门密切关注药品流通使用情况,并监督相关企业和医疗机构配合召回上述药品。此外,国家食药监总局责令两家企业停止上述产品销售,并彻查药品质量问题原因,针对查明的原因进行整改。在未查明原因、未整改到位之前不得恢复销售。

曾提示风险

值得一提的是,监管部门曾提示医疗机构等警惕有关喜炎平注射液、红花注射液的不良反应。

2012年,国家食药监总局发布的药品不良反应通报(第48期)曾提示警惕喜炎平注射液等的严重过敏反应。2011年1月1日至2011年12月31日,国家药品不良反应监测中心病例报告数据库中有关喜炎平注射液的病例报告共计1476例(单用喜炎平注射液病例报告971例,占65.79%)。

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