数百人疑用雅美罗药品后死于并发症,罗氏称尚未确立因果联系

2017-06-10 澎湃新闻 澎湃新闻

6月7日,全球生物制药巨头公司罗氏制药已上市销售的雅美罗(托珠单抗)被外媒曝出,数百位患者在接受雅美罗治疗后死于心血管和肺部并发症,但这些副作用未在雅美罗相关警示说明上出现。

6月7日,全球生物制药巨头公司罗氏制药已上市销售的雅美罗(托珠单抗)被外媒曝出,数百位患者在接受雅美罗治疗后死于心血管和肺部并发症,但这些副作用未在雅美罗相关警示说明上出现。

媒体通过调查超过50万份药物副作用的报告发现,实际上患者使用雅美罗后,出现如心脏病或中风一类的副作用的风险与竞品相比一样高甚至更高。

6月9日晚间,罗氏制药发声明,称媒体报道中提及的不良事件报告系统数据库,既包括提交给FDA(美国食品药品监督管理局)的不良事件,也包括用药错误报告信息。 该数据库旨在支持FDA对药物和治疗生物产品的上市后安全监控计划。

罗氏制药称,该公司一直对上述数据库进行监测和分析,如分析结果提示有必要那就会对产品说明书进行修改和更新,但“目前的数据暂不支持在说明书中列出这些事件”。

罗氏称,如果确立了该公司产品和报告的事件之间的联系,就会采取更新说明书,告知医生、患者和相关监管机构等措施。

截至澎湃新闻发稿,FDA和中国食药监总局(CFDA)尚未就此事发表声明。

据罗氏制药消息,雅美罗已被用于治疗全球超过76万名患者,有超过2万例的临床研究,在中国有超过1万名患者使用。

雅美罗主要用于治疗sJIA(全身型幼年特发性关节炎),针对患者群体为儿童

中国唯一获批治疗sJIA的生物制剂

雅美罗一度是中国市场翘首期盼的明星药。

sJIA是一种自身免疫性疾病,是幼年特发性关节炎(JIA)中最严重的一种亚型,严重影响儿童的生长发育,致残率和死亡率都很高。这种疾病一般在16岁前发病,发病高峰集中在5-7岁。

我国目前约有1.5万名sJIA患儿,男性患儿发病率高于女性患儿。由于缺乏国外已普遍使用的生物制剂,目前我国针对sJIA 的医疗手段以NSAIDs、激素类药物为主,但长期使用激素会给患儿造成诸多不良后果,如生长发育缓慢、肥胖、高血压骨质疏松消化道出血、糖尿病等。

雅美罗针对sJIA的疗效此前曾得到医疗界为数不少的医生支持。

而根据罗氏制药提供给澎湃新闻的信息,雅美罗于2005年在日本获批,由基因泰克在美国销售,并由罗氏其它分支机构在全球115个国家进行销售。

在中国,2013年3月,雅美罗正式获得CFAD的新药上市批准。2016年11月,雅美罗的新适应症“全身型幼年特发性关节炎”(sJIA)获得CFDA免三期临床试验优先批准。

2016年11月29日,罗氏制药举办雅美罗sJIA(全身型幼年特发性关节炎)新适应症上市新闻发布会,宣告雅美罗正式获得治疗这一罕见病准入资格。

雅美罗是中国唯一获批的治疗这一疾病的生物制剂,这意味着1.5万名患儿有了对症的药物。

罗氏:如发现需要警示患者和医生的内容,会及时沟通

6月9日晚间,罗氏中国向澎湃新闻提供了一份《罗氏就个别媒体关于雅美罗不良反应的声明》,强调公司一向严格遵守各国关于药品上市后安全性检测和报告的相关法规要求。

罗氏制药在声明中还表示,根据风险评估,公司会及时主动地更新产品说明书,将监测数据和相关研究结果客观科学的体现在雅美罗说明书中;如发现需要警示患者和医生的内容,会及时与相关机构进行沟通。

雅美罗目前在美国被批准用于类风湿关节炎(RA),全身型幼年特发性关节炎 (sJIA),多关节型幼年特发性关节炎(pJIA) 和巨细胞动脉炎(GCA)。

罗氏制药还在声明中援引了数份学术文章,以说明雅美罗的安全性有保障,其中一份文章认为“根据自雅美罗®批准上市后的安全性数据的监测,安全性情况与雅美罗®中国说明书中托珠单抗的安全性特征保持一致”。

此外,罗氏还声明称,公司会定期向政府递交安全性更新报告,调查结果被列入获益与风险周期性评估报告(PBRER),每六个月发布一次,并向包括FDA在内的卫生部门进行报告。

罗氏制药表示,如果分析结果提示有必要对说明书进行修改,公司将与FDA和其他全球卫生部门合作,对产品说明书进行更新。如果调查确立了产品和报告的事件之间的联系,公司会及时将任何新产品安全性信息告知病人、医生、医护人员和监管机构,更新产品说明书和信息,提供新的安全性信息,并采取行动降低风险(例如,添加产品说明书的禁忌症或建议不良反应发生时应采取的措施),并书面告知医护人员有关使用产品的更新建议。

但罗氏制药同时也认为,“目前的数据暂不支持在说明书中列出这些事件”。

托珠相关的拓展阅读:

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    2017-07-11 丁鹏鹏
  2. 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    2017-06-12 sillywu

    药物滥用太普遍了。患者满意度增加意味着药物滥用和疗效降低

    0

  3. 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createdBy=d27274268, createdName=sillywu, createdTime=Mon Jun 12 10:24:27 CST 2017, time=2017-06-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=209746, encodeId=5f6a209e46f6, content=学习了谢谢分享。, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuEJWOf8El7MfqtlSpy4eWtPl5cxmNJ4ezwbFf5vtCeh53ITyabFpFIJfKTPlzdh6ibOibVONwHUbm9/0, createdBy=a4351715107, createdName=人间可客, createdTime=Mon Jun 12 08:35:34 CST 2017, time=2017-06-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=209724, encodeId=ae70209e2429, content=有没有相关的RCT研究呢?, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3xwU6047w4GQZHmaJMe3cGxCqPS0x43a9R04dN3HrAn5diaR2N4pEwoibqiaiaA3m6ia3g3XbZXadIomlRa5WAvjSUHb/0, createdBy=93aa1715091, createdName=为啥子, createdTime=Mon Jun 12 07:46:19 CST 2017, time=2017-06-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=209545, encodeId=c8ee20954549, content=阅, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM7GibvIBibibnnnvpajk2stlDF5oichYahI6Bia8uxeTBFoPbdoHWebyXf9eal9FNgUF2lNcrwoZicM3BvQ/0, createdBy=a3742066385, createdName=戒馋,懒,贪, createdTime=Sun Jun 11 23:28:31 CST 2017, time=2017-06-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=209531, encodeId=7ded209531ed, content=药厂要赔惨了……, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, 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channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5Kzuf9u71gZhPYMiajRtENwicoAABeQtfXOlic8ibhYSy6DvJZWUDVtjRvTfqBffr1XJ6JLtFB5kHicthl/0, createdBy=d41c2055892, createdName=184****9840, createdTime=Sun Jun 11 08:11:28 CST 2017, time=2017-06-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=209143, encodeId=53ae20914329, content=学习了。。。。。, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/icyLhIGqru6gIknBJqfuPhYUE4da7HxQiaMRRk8Ix0r6sfdeeibLPNib7H5IoNf4kYsecwUsmQC1eUMKsNb65twN7epPZaicdLRCu/0, createdBy=ba1a1999418, createdName=Norene, createdTime=Sun Jun 11 00:19:56 CST 2017, time=2017-06-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=209142, encodeId=df2420914253, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/icyLhIGqru6gIknBJqfuPhYUE4da7HxQiaMRRk8Ix0r6sfdeeibLPNib7H5IoNf4kYsecwUsmQC1eUMKsNb65twN7epPZaicdLRCu/0, createdBy=ba1a1999418, createdName=Norene, createdTime=Sun Jun 11 00:19:50 CST 2017, time=2017-06-11, status=1, ipAttribution=)]
    2017-06-12 人间可客

    学习了谢谢分享。

    0

  4. 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channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5Kzuf9u71gZhPYMiajRtENwicoAABeQtfXOlic8ibhYSy6DvJZWUDVtjRvTfqBffr1XJ6JLtFB5kHicthl/0, createdBy=d41c2055892, createdName=184****9840, createdTime=Sun Jun 11 08:11:28 CST 2017, time=2017-06-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=209143, encodeId=53ae20914329, content=学习了。。。。。, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/icyLhIGqru6gIknBJqfuPhYUE4da7HxQiaMRRk8Ix0r6sfdeeibLPNib7H5IoNf4kYsecwUsmQC1eUMKsNb65twN7epPZaicdLRCu/0, createdBy=ba1a1999418, createdName=Norene, createdTime=Sun Jun 11 00:19:56 CST 2017, time=2017-06-11, status=1, ipAttribution=), 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    2017-06-12 为啥子

    有没有相关的RCT研究呢?

    0

  5. 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channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5Kzuf9u71gZhPYMiajRtENwicoAABeQtfXOlic8ibhYSy6DvJZWUDVtjRvTfqBffr1XJ6JLtFB5kHicthl/0, createdBy=d41c2055892, createdName=184****9840, createdTime=Sun Jun 11 08:11:28 CST 2017, time=2017-06-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=209143, encodeId=53ae20914329, content=学习了。。。。。, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/icyLhIGqru6gIknBJqfuPhYUE4da7HxQiaMRRk8Ix0r6sfdeeibLPNib7H5IoNf4kYsecwUsmQC1eUMKsNb65twN7epPZaicdLRCu/0, createdBy=ba1a1999418, createdName=Norene, createdTime=Sun Jun 11 00:19:56 CST 2017, time=2017-06-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=209142, encodeId=df2420914253, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/icyLhIGqru6gIknBJqfuPhYUE4da7HxQiaMRRk8Ix0r6sfdeeibLPNib7H5IoNf4kYsecwUsmQC1eUMKsNb65twN7epPZaicdLRCu/0, createdBy=ba1a1999418, createdName=Norene, createdTime=Sun Jun 11 00:19:50 CST 2017, time=2017-06-11, status=1, ipAttribution=)]
    2017-06-11 戒馋,懒,贪

    0

  6. 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channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5Kzuf9u71gZhPYMiajRtENwicoAABeQtfXOlic8ibhYSy6DvJZWUDVtjRvTfqBffr1XJ6JLtFB5kHicthl/0, createdBy=d41c2055892, createdName=184****9840, createdTime=Sun Jun 11 08:11:28 CST 2017, time=2017-06-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=209143, encodeId=53ae20914329, content=学习了。。。。。, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/icyLhIGqru6gIknBJqfuPhYUE4da7HxQiaMRRk8Ix0r6sfdeeibLPNib7H5IoNf4kYsecwUsmQC1eUMKsNb65twN7epPZaicdLRCu/0, createdBy=ba1a1999418, createdName=Norene, createdTime=Sun Jun 11 00:19:56 CST 2017, time=2017-06-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=209142, encodeId=df2420914253, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/icyLhIGqru6gIknBJqfuPhYUE4da7HxQiaMRRk8Ix0r6sfdeeibLPNib7H5IoNf4kYsecwUsmQC1eUMKsNb65twN7epPZaicdLRCu/0, createdBy=ba1a1999418, createdName=Norene, createdTime=Sun Jun 11 00:19:50 CST 2017, time=2017-06-11, status=1, ipAttribution=)]
    2017-06-11 cammylee

    药厂要赔惨了……

    0

  7. 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    2017-06-11 1def2877m95(暂无匿称)

    我说过,任何事物都不可以迷信。

    0

  8. 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GetPortalCommentsPageByObjectIdResponse(id=209142, encodeId=df2420914253, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/icyLhIGqru6gIknBJqfuPhYUE4da7HxQiaMRRk8Ix0r6sfdeeibLPNib7H5IoNf4kYsecwUsmQC1eUMKsNb65twN7epPZaicdLRCu/0, createdBy=ba1a1999418, createdName=Norene, createdTime=Sun Jun 11 00:19:50 CST 2017, time=2017-06-11, status=1, ipAttribution=)]
    2017-06-11 184****9840

    学习了谢谢分享。

    0

  9. 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createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3xwU6047w4GQZHmaJMe3cGxCqPS0x43a9R04dN3HrAn5diaR2N4pEwoibqiaiaA3m6ia3g3XbZXadIomlRa5WAvjSUHb/0, createdBy=93aa1715091, createdName=为啥子, createdTime=Mon Jun 12 07:46:19 CST 2017, time=2017-06-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=209545, encodeId=c8ee20954549, content=阅, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM7GibvIBibibnnnvpajk2stlDF5oichYahI6Bia8uxeTBFoPbdoHWebyXf9eal9FNgUF2lNcrwoZicM3BvQ/0, createdBy=a3742066385, createdName=戒馋,懒,贪, createdTime=Sun Jun 11 23:28:31 CST 2017, time=2017-06-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=209531, encodeId=7ded209531ed, content=药厂要赔惨了……, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, 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channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5Kzuf9u71gZhPYMiajRtENwicoAABeQtfXOlic8ibhYSy6DvJZWUDVtjRvTfqBffr1XJ6JLtFB5kHicthl/0, createdBy=d41c2055892, createdName=184****9840, createdTime=Sun Jun 11 08:11:28 CST 2017, time=2017-06-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=209143, encodeId=53ae20914329, content=学习了。。。。。, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/icyLhIGqru6gIknBJqfuPhYUE4da7HxQiaMRRk8Ix0r6sfdeeibLPNib7H5IoNf4kYsecwUsmQC1eUMKsNb65twN7epPZaicdLRCu/0, createdBy=ba1a1999418, createdName=Norene, createdTime=Sun Jun 11 00:19:56 CST 2017, time=2017-06-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=209142, encodeId=df2420914253, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/icyLhIGqru6gIknBJqfuPhYUE4da7HxQiaMRRk8Ix0r6sfdeeibLPNib7H5IoNf4kYsecwUsmQC1eUMKsNb65twN7epPZaicdLRCu/0, createdBy=ba1a1999418, createdName=Norene, createdTime=Sun Jun 11 00:19:50 CST 2017, time=2017-06-11, status=1, ipAttribution=)]
    2017-06-11 Norene

    学习了。。。。。

    0

  10. 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    2017-06-11 Norene

    学习了

    0

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