FDA更新其多州洋葱球茎病伯克氏菌感染爆发情况

GMP News
25/10/2016

FDA Updates on Multistate Outbreak of Burkholderia cepacia Infections

FDA更新其多州洋葱球茎病伯克氏菌感染爆发情况

A multistate outbreak of Burkholderia cepacia has caused investigations of the US FDA and CDC. These investigations identified Burkholderia cepacia in more than 10 lots of oral liquid docusate sodium manufactured by PharmaTech, Davie, Florida. Additinally B.cepacia was found in the water system which was used to manufacture the oral liquid docusate sodium. These products were manufactured by PharmaTech and distributed and labeled by six firms – Rugby, Major, Bayshore, Metron, Centurion, and Virtus.

多个州洋葱球茎病伯克氏菌爆发已经引发美国FDA和CDC的调查。调查显示在弗罗里达Phmarma Tech生产的超过10个批次的液体口服琥珀辛酯钠中检出葱球茎病伯克氏菌。另外，在用于生产口服琥珀辛酯钠的水系统中发现B伯克氏菌。这些药品是由PharmaTech生产，由6个公司贴标销售的---- Rugby, Major, Bayshore, Metron, Centurion, and Virtus。

Further the FDA stated: FDA进一步声明：

"FDA also inspected other oral liquid docusate sodium manufacturers and collected samples of their products. The bacteria associated with this multistate outbreak has not been found in other oral liquid docusate sodium products FDA tested.

“FDA也检查了其它口服液体琥珀辛酯钠生产商，收集了他们的产品样本。在FDA所检测的其它口服液体琥珀辛酯钠产品中没有发现与此次多州爆发相关的细菌。

Laboratory evidence from FDA and CDC supports PharmaTech as the source of this outbreak.

FDA和CDC化验室的证据支持PharmaTech是此次爆发的来源。

In addition, FDA’s current laboratory results do not indicate the active pharmaceutical ingredient used to manufacture oral liquid docusate is a source of the B. cepacia outbreak.

此外，FDA目前化验室结果并未显示用于生产口服液体琥珀辛酯钠原料药是B伯克氏菌爆发的来源。

Health care professionals may resume normal use of oral liquid docusate sodium not manufactured by PharmaTech.

健康专家可以恢复正常使用不是PharmaTech生产的口服液体琥珀辛酯钠。

FDA reminds manufacturers of the importance of robust manufacturing and testing of liquid products such as docusate sodium to ensure low levels of microorganisms and the absence of those that may cause infection. "

FDA提醒生产商稳定生产的重要性，以及液体产品检测的重要性，如琥珀辛酯钠，以确保低水平的微生物，确保其不会引发感染。”

For health care professionals or patients who want to report further events or quality problems experienced with the use of oral liquid docusate sodium products can do this with the FDA’s MedWatch Adverse Event Reporting program.

需要报告更多由于使用口服液体琥珀辛酯钠产品引起的事件或质量问题的健康专家和患者可以联系FDA医药观察不良事件报告中心。

For more information please see "Updates on Multistate Outbreak of Burkholderia cepacia Infections"

更多信息参见官网。

来源：Julia