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争议中的硝基呋喃类抗菌药 被药监局下了一剂猛药

2019-02-19 觅苓 CPhI制药在线

近日,NMPA在公告中指出:经国家药品监督管理局组织再评价,认为含呋喃唑酮复方制剂存在严重不良反应,在我国使用风险大于获益,决定自即日起停止含呋喃唑酮复方制剂在我国的生产、销售和使用,撤销药品批准证明文件


近日,NMPA在公告中指出:经国家药品监督管理局组织再评价,认为含呋喃唑酮复方制剂存在严重不良反应,在我国使用风险大于获益,决定自即日起停止含呋喃唑酮复方制剂在我国的生产、销售和使用,撤销药品批准证明文件。

含呋喃唑酮复方制剂

硝基呋喃类抗菌药是一类重要的人工合成广谱抗菌药,主要包括呋喃唑酮、呋喃西林、呋喃它酮和呋喃妥因等,这类药物主要用于治疗革兰氏菌(革兰氏阳性菌和革兰氏阴性菌)、真菌和一些原虫引起的疾病。曾经,这些药物被广泛用于人类感染的治疗以及畜禽和水产养殖业中。但后来临床使用发现,硝基呋喃类药物及其代谢产物具有较大的毒副作用,包括可诱发癌症。

因此,美国在1993年就禁止将呋喃唑酮用作兽药使用在食品动物上(2002年禁止所有硝基呋喃类药物在动物性食品中的使用);欧盟也于1995年全面禁止(包括人和动物)使用呋喃唑酮类抗菌药;在我国也已明令禁止在食用动物上使用呋喃唑酮等硝基呋喃类药物。但由于硝基呋喃类抗菌药由于疗效明确的优点,我国并未禁止其用于人类疾病的治疗。因此,硝基呋喃类抗菌药的使用到底是获益大于风险,还是风险大于获益一直备受争议,是一种"争议"的存在!

近日,我国药监局对这一争议下了一剂猛药,明确停止了生产销售使用含呋喃唑酮复方制剂!如图一所示,NMPA在公告中指出:经国家药品监督管理局组织再评价,认为含呋喃唑酮复方制剂存在严重不良反应,在我国使用风险大于获益,决定自即日起停止含呋喃唑酮复方制剂在我国的生产、销售和使用,撤销药品批准证明文件。

在公告的附件中,NMPA明确了我国含呋喃唑酮复方制剂生产企业名单(表一),并要求这些企业对已上市销售的含呋喃唑酮复方制剂实行召回,明确规定召回工作在2019年3月31日前完成,召回产品由企业所在地药品监督管理部门监督销毁。

表一 含呋喃唑酮复方制剂生产企业名单

含呋喃唑酮复方制剂于上世纪七十年代开始在我国批准上市,适应症为细菌和原虫引起的各种肠道感染性疾病。含呋喃唑酮复方制剂严重不良反应主要为严重皮肤反应、多发性神经炎等。当然,本次NMPA指出的是呋喃唑酮复方制剂,并非呋喃唑酮本身。

其实,就呋喃唑酮本身来说,其副作用也是非常大的,主要包括以下几个方面:

1. 造血系统毒性:如溶血性贫血、血小板减少性紫癜等;

2. 神经系统毒性:如多发性神经炎、精神障碍等;

3. 全身性反应:如双硫醒样反应、多系统疾病等;

4. 眼部损害:如双眼上直肌痉挛、眼部改变、视神经炎等;

5. 消化系统及其他毒性:如急性肝坏死、肢痛、药疹等。

由此可见,呋喃唑酮本身也是问题较多,因此,NMPA也多次对呋喃唑酮片的说明书进行修订,比如增加警示语:葡萄糖-6-磷酸脱氢酶缺乏性患者使用本品容易发生溶血性贫血,禁用于该人群;并明确规定14岁以下儿童禁用。

呋喃唑酮复方在我国药物史上即将成为过去时,而呋喃唑酮药物本身尚在争议中坚持,但NMPA早已明确指出:各呋喃唑酮片生产企业应当对新增不良反应发生机制开展深入研究,采取有效措施做好使用和安全性问题的宣传培训,指导医师合理用药。此外,NMPA还要求临床医师在选择用药时根据新修订说明书进行充分的效益/风险分析。由此,笔者在此提醒广大药企及药物研发人员在药物开发的时候或许可以适当的避开呋喃唑酮等硝基呋喃类药物。

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    2020-03-15 1488158em19暂无昵称

    呋喃妥因导致的周围神经病,采用哪种解毒剂

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    2019-02-21 xuyu
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  4. [GetPortalCommentsPageByObjectIdResponse(id=380492, encodeId=445b380492df, content=呋喃妥因导致的周围神经病,采用哪种解毒剂, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b4405308671, createdName=1488158em19暂无昵称, createdTime=Sun Mar 15 13:06:14 CST 2020, time=2020-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301645, encodeId=b54b130164552, content=<a href='/topic/show?id=2ba78e935dc' target=_blank style='color:#2F92EE;'>#药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87935, encryptionId=2ba78e935dc, topicName=药监局)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f5b299, createdName=xuyu, createdTime=Thu Feb 21 13:15:00 CST 2019, time=2019-02-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1330804, encodeId=6db313308049a, content=<a href='/topic/show?id=c6b455688d1' target=_blank style='color:#2F92EE;'>#抗菌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55688, encryptionId=c6b455688d1, topicName=抗菌)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/2898B09F0DA89357D0D54A725E611AC7/100, createdBy=fdd32500040, createdName=ms7899726347904398, createdTime=Thu Feb 21 13:15:00 CST 2019, time=2019-02-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1373105, encodeId=693313e3105db, content=<a href='/topic/show?id=eb2555e176c' target=_blank style='color:#2F92EE;'>#抗菌药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55717, encryptionId=eb2555e176c, topicName=抗菌药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7e12358, createdName=lhlxtx, createdTime=Thu Feb 21 13:15:00 CST 2019, time=2019-02-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=361096, encodeId=8a52361096ea, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=18741984753, createdName=smartxiuxiu, createdTime=Wed Feb 20 08:15:53 CST 2019, time=2019-02-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=361047, encodeId=c54936104ee2, content=了解一下,谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/12/23/2f51002e1349ccda5be11c1eea1e1e60.jpg, createdBy=a22097948, createdName=天地飞扬, createdTime=Tue Feb 19 22:27:25 CST 2019, time=2019-02-19, status=1, ipAttribution=)]
    2019-02-21 lhlxtx
  5. [GetPortalCommentsPageByObjectIdResponse(id=380492, encodeId=445b380492df, content=呋喃妥因导致的周围神经病,采用哪种解毒剂, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b4405308671, createdName=1488158em19暂无昵称, createdTime=Sun Mar 15 13:06:14 CST 2020, time=2020-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301645, encodeId=b54b130164552, content=<a href='/topic/show?id=2ba78e935dc' target=_blank style='color:#2F92EE;'>#药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87935, encryptionId=2ba78e935dc, topicName=药监局)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f5b299, createdName=xuyu, createdTime=Thu Feb 21 13:15:00 CST 2019, time=2019-02-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1330804, encodeId=6db313308049a, content=<a href='/topic/show?id=c6b455688d1' target=_blank style='color:#2F92EE;'>#抗菌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55688, encryptionId=c6b455688d1, topicName=抗菌)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/2898B09F0DA89357D0D54A725E611AC7/100, createdBy=fdd32500040, createdName=ms7899726347904398, createdTime=Thu Feb 21 13:15:00 CST 2019, time=2019-02-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1373105, encodeId=693313e3105db, content=<a href='/topic/show?id=eb2555e176c' target=_blank style='color:#2F92EE;'>#抗菌药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55717, encryptionId=eb2555e176c, topicName=抗菌药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7e12358, createdName=lhlxtx, createdTime=Thu Feb 21 13:15:00 CST 2019, time=2019-02-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=361096, encodeId=8a52361096ea, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=18741984753, createdName=smartxiuxiu, createdTime=Wed Feb 20 08:15:53 CST 2019, time=2019-02-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=361047, encodeId=c54936104ee2, content=了解一下,谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/12/23/2f51002e1349ccda5be11c1eea1e1e60.jpg, createdBy=a22097948, createdName=天地飞扬, createdTime=Tue Feb 19 22:27:25 CST 2019, time=2019-02-19, status=1, ipAttribution=)]
    2019-02-20 smartxiuxiu

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=380492, encodeId=445b380492df, content=呋喃妥因导致的周围神经病,采用哪种解毒剂, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b4405308671, createdName=1488158em19暂无昵称, createdTime=Sun Mar 15 13:06:14 CST 2020, time=2020-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301645, encodeId=b54b130164552, content=<a href='/topic/show?id=2ba78e935dc' target=_blank style='color:#2F92EE;'>#药监局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87935, encryptionId=2ba78e935dc, topicName=药监局)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f5b299, createdName=xuyu, createdTime=Thu Feb 21 13:15:00 CST 2019, time=2019-02-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1330804, encodeId=6db313308049a, content=<a href='/topic/show?id=c6b455688d1' target=_blank style='color:#2F92EE;'>#抗菌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55688, encryptionId=c6b455688d1, topicName=抗菌)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/2898B09F0DA89357D0D54A725E611AC7/100, createdBy=fdd32500040, createdName=ms7899726347904398, createdTime=Thu Feb 21 13:15:00 CST 2019, time=2019-02-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1373105, encodeId=693313e3105db, content=<a href='/topic/show?id=eb2555e176c' target=_blank style='color:#2F92EE;'>#抗菌药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55717, encryptionId=eb2555e176c, topicName=抗菌药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7e12358, createdName=lhlxtx, createdTime=Thu Feb 21 13:15:00 CST 2019, time=2019-02-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=361096, encodeId=8a52361096ea, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=18741984753, createdName=smartxiuxiu, createdTime=Wed Feb 20 08:15:53 CST 2019, time=2019-02-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=361047, encodeId=c54936104ee2, content=了解一下,谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/12/23/2f51002e1349ccda5be11c1eea1e1e60.jpg, createdBy=a22097948, createdName=天地飞扬, createdTime=Tue Feb 19 22:27:25 CST 2019, time=2019-02-19, status=1, ipAttribution=)]
    2019-02-19 天地飞扬

    了解一下,谢谢分享!

    0

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