藥物警訊（藥師週刊 第1726期）

Irinotecan Hydrochloride Injection: Recall - Fungal Microbial Contaminant

AUDIENCE: Oncology, Pharmacy, Risk Manager

APP Pharmaceuticals, Inc. issued a voluntary recall of five lots of Irinotecan Hydrochloride Injection due to the discovery of foreign material and non-sterility in one lot of Irinotecan injection. Non-sterility of a chemotherapeutic product administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised.

BACKGROUND: Irinotecan Hydrochloride Injection is used for recurrent or progressive metastatic colorectal cancer. Three customers reported that they discovered a particulate in the product solution in lot 870DE00301. Investigation of the returned vials confirmed that the particulate was a fungal microbial contaminant. See the Firm Press Release for a listing of recalled lot numbers.

RECOMMENDATION: Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

因為發現某一批irinotecan HCL針劑非無菌且含有異物，APP製藥公司發佈自願性的回收五批irinotecan HCL針劑。透過靜脈注射非無菌的化療藥品可能會引起感染，特別在免疫不全的病人更可能致死。

Irinotecan HCL針劑是用來治療復發或持續進展的轉移性大腸直腸癌。有三名人員回報他們在批號870DE00301的產品中發現微粒，而調查後確認微粒為黴菌污染。 詳見FDA網站上Firm Press Release的藥品回收批號。

使用此產品的病人如果有任何問題，請連繫醫師或醫療專業人員，因為該問題可能是與產品相關。

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation /SafetyAlertsforHumanMedicalProducts/ucm248598.htm
[Posted 03/28/2011]

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