藥物警訊（藥師週刊第1801期）

FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised - Update

CDC and FDA have confirmed the presence of a fungus known as Exserohilum rostratum?in unopened medication vials of preservative-free methylprednisolone acetate (80mg/ml) from one of the three implicated lots from NECC (Lot #08102012@51, BUD 2/6/2013). The laboratory confirmation further links steroid injections from these lots from NECC to the multistate outbreak of fungal meningitis and joint infections. Testing on the other two implicated lots of methylprednisolone acetate and other NECC injectables continues.

CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from three implicated lots of methylprednisolone and nearly 97% of these patients have been contacted for further follow-up.

There is now available a Patient Notification Letter on the FDA "Update on Fungal Meningitis" webpage under the "Related Information" section. This letter template is for healthcare professionals notifying patients administered a drug produced by the New England Compounding Center (NECC) that has been recalled.

Read the MedWatch Alert, including a link to the FDA Statement at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

CDC和FDA於未開封且無防腐劑之藥品methylprednisolone acetate (80 mg/mL)的三個相連批號之中發現黴菌Exserohilum rostratum。實驗室進一步證實這些NECC的類固醇注射劑與此於多處爆發之黴菌性腦膜炎和關節感染有關。另外兩批號之 methylprednisolone acetate與NECC的其他注射劑正在檢驗中。

CDC和地區健康中心估計大約有14000名病人可能已接受過此三批號之methylprednisolone注射劑，接近97 %之病人已經取得聯繫作進一步的觀察。

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation /SafetyAlertsforHumanMedicalProducts/ucm323946.htm
[Posted 10/18/2012]

資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部

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