FDA确认NECC的未开封甲基强的松龙药瓶中有突脐蠕孢真菌

圣路易斯(MD Consult)——2012年10月18日，美国食品药品管理局(FDA)和疾病预防控制中心(CDC)更新了关于多州爆发与注射新英格兰复合中心(NECC)生产的注射用药物相关的真菌性脑膜炎和关节感染的信息，确认在NECC的3个受累批次无防腐剂醋酸甲基强的松龙(80 mg/ml)的1个批次中(Lot , BUD 2/6/2013)，发现未开封的药瓶中存在名为突脐蠕孢的真菌。

这一实验室检查结果进一步确认了注射NECC的上述批次类固醇激素药物与当前的真菌性脑膜炎和关节感染爆发之间存在关联。目前，仍在继续对其他2个受累批次的醋酸甲基强的松龙和其他NECC注射用药物进行检测。

CDC和州卫生部门估计，大约有14,000例患者可能注射了这3个受累批次的甲基强的松龙，并且已与其中接近97%的患者取得联系，以便进一步随访。截至2012年10月18日，CDC报告的真菌感染病例数为257例，死亡数为20例。

FDA已生成了一个患者通告书模板，医疗保健专业人员将把这种通告书发送至曾注射已召回的NECC产品的患者。FDA还提供了一个药品信息热线电话[855-543-DRUG (3784)，然后按*]，供患者和医疗保健专业人员呼叫和获取关于召回产品的最新信息并直接与药剂师对话。

要求临床医生将使用NECC产品后发生的任何可疑不良事件报告至FDA的MedWatch不良事件报告系统。

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ST LOUIS (MD Consult) - On October 18, 2012, the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) issued an update regarding the current multistate outbreak of fungal meningitis and joint infections related to injections of products from the New England Compounding Center (NECC). These agencies have confirmed the presence of a fungus known as Exserohilum rostratumin, derived from unopened medication vials of preservative-free methylprednisolone acetate (80 mg/ml) from 1 of the 3 implicated lots from NECC (Lot , BUD 2/6/2013).

This laboratory confirmation further links steroid injections from these lots from NECC to the current outbreak of fungal meningitis and joint infections. Testing on the other 2 implicated lots of methylprednisolone acetate and other NECC injectables continues.

The CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from the 3 implicated lots of methylprednisolone, and nearly 97% of these patients have been contacted for further follow-up. As of October 18, 2012, the CDC places the case count of fungal infections at 257, and the death count at 20.

The FDA has produced a Patient Notification Letter template for use by health care professionals to send to their patients who have received injections of recalled products from the NECC. The FDA has also provided a drug information telephone line (855-543-DRUG [3784] and press *) for patients and health care professionals to call and obtain the most recent information regarding the meningitis recall and to speak directly to a pharmacist.

Clinicians are requested to report any suspected adverse events that occur after the use of the NECC products to the FDA's MedWatch Adverse Event Reporting Program.