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FDA将审查阿奇霉素的心血管风险

来源:环球医学编译    时间:2012年05月18日    点击数:    5星

5月18日消息 - 环球医学据悉,美国食品和药物管理局(FDA)近日宣布,其将审查一项新的研究,该研究显示,服用阿奇霉素(希舒美,辉瑞公司)的患者与服用阿莫西林、环丙沙星,或不服用任何抗生素的人相比,其突发心源性猝死的风险略微增加。

此项观察性研究近日发表于《新英格兰医学杂志》(NEJM)上,该研究在为期5日的阿奇霉素疗程中观察了医疗补助方案患者。

在其公告中,FDA提醒临床医生,QT间期延长不仅与阿奇霉素有关,还与其他属于这一类别的抗生素有关,而QT间期延长可引发一个异常的,有时甚至是致命的心律失常——扭转性室速(TdP)。阿奇霉素所属类别为大环内酯类,该类别还包括克拉霉素(Biaxin,雅培)和红霉素,该研究并未把这两种药物包括在内。

FDA补充说,患者在未咨询临床医生的情况下不应擅自停用阿奇霉素。

自2011年起,大环内酯类抗生素的问题和心血管疾病死亡风险一直处于FDA的监测之下,那时FDA审查了这些药物有关这一问题的标签。在3月时,FDA修订了缓释型阿奇霉素口服混悬液(Zmax,辉瑞公司)标签中的警告和注意事项部分,提及有关QT间期延长和TdP的报告,并建议临床医生避免为已知有QT间期延长的患者、低钾患者,或正在服用延长QT间期药物的患者开具该类抗生素处方。克拉霉素和红霉素的标签同样也提到了QT间期延长。FDA将以类似的方式修改其他大环内酯类抗生素的标签。

FDA表示,在审查了该项NEJM的研究后,将向公众公布最新的有关阿奇霉素或QT间期延长潜在风险的信息。(环球医学)

原文:

FDA to Review CV Risk With Azithromycin After NEJM Study

The US Food and Drug Administration (FDA) will review a new study showing that patients taking azithromycin (Zithromax, Pfizer) face a small increased risk for sudden cardiac death compared with patients taking amoxicillin, ciprofloxacin, or no antibiotic at all, the agency announced today.

The observational study, published today in the New England Journal of Medicine (NEJM), looked at Medicaid patients on a 5-day course of azithromycin.

In its announcement, the FDA reminded clinicians that QT interval prolongation, which can trigger an abnormal and sometimes fatal heart arrhythmia called torsades de pointes (TdP), has been linked not only with azithromycin but also with other antibiotic drugs in its class. That class, called macrolides, also includes clarithromycin (Biaxin, Abbott) and erythromycin, neither of which figured into the NEJM study.

Patients taking azithromycin should not stop taking it without consulting a clinician, the FDA added.

The issue of macrolides and the risk for cardiovascular death has been on the FDA's radar since 2011, when it reviewed the labels for these drugs on this issue. In March, the FDA revised the warnings and precautions section of an extended-release, oral suspension version of azithromycin (Zmax, Pfizer) to mention reports of QT interval prolongation and TdP and advise clinicians to avoid prescribing the antibiotic for patients with known QT interval prolongation, patients with low potassium, or those taking drugs that prolong the QT interval. The labels for clarithromycin and erythromycin also mention QT interval prolongation. The agency will be revising the labels of other macrolides in similar fashion.

The FDA said that it would update the public on any new information on azithromycin or the potential risk for QT interval prolongation after it reviews the NEJM study.
 

相关链接:http://www.medscape.com/viewarticle/763995

 

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