Serdolect Is Effective But Safety Is Issue, Advisory Committee Says Again

Christopher Hollis

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Serdolect Is Effective But Safety Is Issue, Advisory Committee Says Again

机译：咨询委员会再次表示，Serdolect有效，但安全问题

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The FDA's Psychopharmacological Drugs Advisory Committee decided that Lundbeck's antipsychotic Serdolect was unacceptably safe to treat schizophrenia after the FDA presented data showing the product had a fivefold increased risk for sudden cardiac death compared with risperidone and no proven suicide benefit. The company wants to market Serdolect (sertindole) to treat schizophrenia and reduce the risk of suicide and suicide attempts in schizophrenic patients. The FDA action date is May 15.rnThe committee voted 12-1 last week to tell the FDA that Serdolect does not have an acceptable safety profile. Members voted unanimously to recommend the drug's efficacy against schizophrenia but said the product failed to show a benefit in reducing suicides.

机译：FDA的心理药物咨询委员会认为，在FDA提交的数据显示该产品与利培酮相比，心脏猝死的风险增加了五倍，并且没有证明的自杀益处，Lundbeck的抗精神病药Serdolect在治疗精神分裂症方面是不可接受的安全性。该公司希望将Serdolect（sertindole）推向市场，以治疗精神分裂症并降低精神分裂症患者自杀和自杀企图的风险。 FDA的行动日期是5月15日。委员会上周以12比1的投票结果告知FDA Serdolect没有可接受的安全性。成员一致投票推荐该药对精神分裂症的疗效，但表示该产品未能显示出减少自杀的益处。

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《Washington Drug Letter》 |2009年第15期|1-14-46-6|共3页
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Christopher Hollis;
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Serdolect Is Effective But Safety Is Issue, Advisory Committee Says Again

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