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两款注射液多个批次现不良反应 遭下令召回

2017-09-25 07:21:53   中国经济网

青峰药业方面同时向《每日经济新闻》记者表示,由于目前药品具体问题原因尚未查出,将会配合各地方食药监在召回后进行检验查出具体问题。

《每日经济新闻》记者也曾于9月24日拨打振东安特生物行政电话,但对方表示“无法回应”。

对公司业绩影响几何?

据振东制药公告,2011年5月,振东制药收购振东安特生物100%股权,交易对价为1.12亿元,此后,振东制药对振东安特生物增资并进行新厂建设。

红花注射液为振东制药主要产品之一,用于治疗闭塞性脑血管疾病,冠心病,脉管炎。振东制药2017年中报显示,公司生产的红花注射液市场占比为4.61%。

对于“不合格热原”这一说法,江苏省食品药品监督管理局药品不良反应监测处主任赵起此前曾对媒体解释说,生产药物的原材料、所处的环境甚至是呼吸的空气都不是无菌的,因此在药物生产过程中就有灭菌环节。但一些细菌、霉菌等微生物被消灭后,细胞被破坏,微生物的内毒素仍会被释放出来。这些内毒素进入人体后会引起人体防御机制的作用,使人体出现寒战、发烧等症状。这些灭菌遗留产物就是热原。

而喜炎平注射液主要用于支气管炎,扁桃体炎,细菌性痢疾等,《每日经济新闻》记者同时注意到,在国内仅青峰药业一家拥有喜炎平注射液的生产批文,青峰药业方面也向记者确认,喜炎平注射液为其独家产品,对其业绩贡献“肯定是超过五成了”。

上述批次药品,均属于中药注射液。而就在本月,新版医保目录才在执行中对中药注射液做出了一些限制,如对部分中药注射液产品限制支付范围为二级以上医院(含二级医院)。就这些限制,第三方医药服务体系麦斯康莱创始人史立臣还曾在分析原因时表示,近些年中药注射液在基层医院大量使用,出现了问题,而新版医保目录中的限定是考虑到当出现问题时,二级及二级以上医院可以解决问题,而一些基层小诊所未具备相关能力,可能会造成更大伤害。而对中药注射液生产企业来说,如果此前并未做出相应的应对措施——如注射改口服,那么对公司业绩会产生很大不利影响。

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