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FDA发出安全警告:2型糖尿病药物SGLT2抑制剂与严重的生殖器感染存在相关性

2018-08-30 MedSci MedSci原创

FDA发出警告称:SGLT2抑制剂,包括阿斯利康的Farxiga(dapagliflozin)和礼来的Jardiance(empagliflozin),与会阴坏死性筋膜炎(又称为阴囊坏疽)的疾病具有相关性。FDA表示需要在所有SGLT2抑制剂的处方信息中添加关于此风险的新警告。

FDA发出警告称:SGLT2抑制剂,包括阿斯利康的Farxiga(dapagliflozin)和礼来的Jardiance(empagliflozin),与会阴坏死性筋膜炎(又称为阴囊坏疽)的疾病具有相关性。FDA表示需要在所有SGLT2抑制剂的处方信息中添加关于此风险的新警告。

根据FDA的报告显示,在2013年3月至2018年5月开始服用SGLT2糖尿病药物后的几个月内,12名患者出现了阴囊坏疽疾病。受试者都住院并接受了手术治疗,一名患者死亡。与此同时,FDA还指出,在30多年的时间里,在对其他所有的糖尿病药物的审查中只发现了6例阴囊坏疽病例。

SGLT抑制剂,还包括强生的Invokana(canagliflozin)和默克的Steglatro(ertugliflozin),被批准用于与饮食和运动疗法联用用以降低2型糖尿病患者的血糖。礼来的Jardiance还被批准用于降低2型糖尿病和心脏病成年患者的心脏病发作和中风死亡的风险。

FDA指出,2017年约有170万名患者接受了零售药房的SGLT抑制剂的药物治疗,分析师估计到2020年这些产品的销售额将高达71亿美元。

为响应这一警告,阿斯利康表示正在与FDA合作更新Farxiga的标签,并指出在药物开发过程中没有发现任何病例。

原始出处:


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    2018-09-16 tulenzi
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  5. 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beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Thu Aug 30 21:37:29 CST 2018, time=2018-08-30, status=1, ipAttribution=)]
  6. 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  7. 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href='/topic/show?id=1f13e6767e9' target=_blank style='color:#2F92EE;'>#糖尿病药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76767, encryptionId=1f13e6767e9, topicName=糖尿病药物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5edb17003695, createdName=minhuang75_72521589, createdTime=Sat Sep 01 12:02:00 CST 2018, time=2018-09-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1041811, encodeId=6d09104181167, content=谢谢MedSci提供最新的资讯, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=misszhang, createdTime=Fri Aug 31 00:02:00 CST 2018, time=2018-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=341812, encodeId=1cd8341812b9, content=应该警惕, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Thu Aug 30 21:37:29 CST 2018, time=2018-08-30, status=1, ipAttribution=)]
    2018-09-01 jiekemin
  8. 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  9. 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beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Thu Aug 30 21:37:29 CST 2018, time=2018-08-30, status=1, ipAttribution=)]
    2018-08-31 misszhang

    谢谢MedSci提供最新的资讯

    0

  10. 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    2018-08-30 医者仁心5538

    应该警惕

    0

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