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青峰药业喜炎平被责令停用并召回
2017-09-25 07:31:54 中国经济网
9月23日,国家食品药品监督管理总局发布通告称,江西青峰药业有限公司(以下简称“青峰药业”)生产的喜炎平注射液和山西振东安特生物制药有限公司(以下简称“安特生物”)生产的红花注射液发生多例不良反应,要求所有医疗机构立即停止使用涉事批次产品,并责令企业召回问题批号产品。
通告显示,经国家药品不良反应监测中心监测发现,青峰药业生产的喜炎平注射液在甘肃(涉事批号:2017041303)、黑龙江(涉事批号:2017042303)、江苏(涉事批号:2017061003)共发生十多例寒战、发热等严重不良反应。安特生物生产的红花注射液(批号:20170404)在山东、新疆等地发生10例寒战、发热等不良反应。
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,责令青峰药业和安特生物立即召回上述批号产品并停止上述产品销售,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。要求山西省食品药品监督管理局、江西省食品药品监督管理局监督企业停止涉事品种的销售,确保药品全部召回,并对相关药品生产企业立案调查,依法严肃查处违法违规行为。
事实上,2012年6月,国家食药监总局就曾发布药品不良反应信息通报,喜炎平注射液在使用过程中产生过敏反应占比较大,安全性问题突出,建议过敏体质者、老人、儿童、肝肾功能异常患者等特殊人群和初次使用中药注射剂的患者慎用。
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