FDA对Ameridose的检查引发大量产品召回

圣路易斯(MD Consult)——2012年10月31日，美国食品药品管理局(FDA)和Ameridose宣布从市场上召回后者的所有未过期产品。Ameridose提供的清单(53页)包括多种口服和注射产品。发起此次召回的起因是，FDA在对Ameridose工厂的初步检查中发现，该工厂生产的产品并不能确保无菌。

这次召回并不属于患者发生相关感染的事故。Ameridose尚未接获任何与使用应召回产品有关的不良事件报告。Ameridose和FDA均未在任何产品中检出杂质。

本次对Ameridose工厂的检查是由FDA与马萨诸塞州共同开展的，属于针对当前真菌性脑膜炎疫情的调查的一部分。Ameridose是一家与新英格兰合成中心(NECC)有关联的公司，而NECC涉及当前的真菌性脑膜炎疫情。

FDA警告称，使用非无菌的注射剂可给健康人带来严重威胁，甚至导致危及生命的损害。由该工厂生产或配送的产品大多被Ameridose标注为无菌产品。Ameridose自愿与马萨诸塞州制药注册委员会达成协议，决定从2012年10月10日起停止所有制药和生产运营。

FDA还建议，医务人员不必对获得了Ameridose产品的患者进行随访。医务人员目前应停止使用Ameridose产品，并将其交还公司。Ameridose正在通过传真通知消费者，并且正在安排对召回产品的处理。

FDA已确定，若干种Ameridose产品目前正被列在严重短缺名单上。这些产品在Ameridose召回之前就已处于缺货状态，而它们的供应可能会受到召回的进一步影响。FDA正在与替代生产商协作，以维持这些可挽救生命的产品的供应。

FDA建议医务人员和消费者将与使用应召回产品有关的任何不良反应报告至FDA的MedWatch不良事件报告系统。

爱思唯尔版权所有  未经授权请勿转载

ST LOUIS (MD Consult) - On October 31, 2012, the US Food and Drug Administration (FDA) and Ameridose announced the recall of all of its unexpired products in circulation. The list (53 pages) provided by Ameridose includes various oral and injectable products. The decision to conduct this recall was made on the basis of the FDA's preliminary facility inspection findings that have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility.

This recall is not occurring because of reports of patients with infections associated with any of Ameridose's products, and the FDA recommended this recall out of an abundance of caution. Ameridose has not received any adverse reports related to the products subject to this recall and neither Ameridose nor the FDA has identified impurities in any Ameridose products.

Together with the State of Massachusetts, the FDA commenced the current inspection of the Ameridose facility as part of the agency's ongoing fungal meningitis outbreak investigation. Ameridose is a company sharing common management by the same parties as New England Compounding Center (NECC) of Framingham Massachusetts, the firm associated with compounded drugs linked to the ongoing fungal meningitis outbreak.

The FDA warns that the use of non-sterile injectable products can represent a serious hazard to health that could lead to life-threatening injuries. Most products produced at and distributed by this facility are represented by Ameridose to be sterile products. Ameridose entered into a voluntary agreement with the Massachusetts Board of Registration in Pharmacy to cease all pharmacy and manufacturing operations starting on October 10, 2012.

At this time, the FDA is also recommending that health care professionals do not need to follow up with patients who received Ameridose products. Health care professionals should stop using Ameridose products at this time, and return them to the firm. Ameridose is notifying its customers by fax and is arranging for return of all recalled products.

The FDA has identified some Ameridose products that currently appear on the critical shortage list. These products were in shortage before the Ameridose recall, but supplies may be further affected as a result of the Ameridose recall. The FDA is working with alternative manufacturers to maintain supplies of these life-saving drugs.

The FDA is asking health care professionals and consumers to report any adverse reactions related to the use of the recalled products to the FDA's MedWatch Adverse Event Reporting Program.