藥物警訊

Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections

AUDIENCE: Pharmacy, Patient, Health Professional

ISSUE: Bacterial infections have been potentially associated with contaminated calcium gluconate infusions produced by Specialty Compounding, Cedar Park, TX.

FDA has received reports of 15 adverse events experienced by patients in two hospitals. The 15 patients received an infusion of calcium gluconate 2 grams in Sodium Chloride 0.9% for Injection, which was supplied by Specialty Compounding. The patients then developed bacterial bloodstream infections caused by Rhodococcus equi. These infections are thought to be related to the infusions. Cultures from an intact sample of calcium gluconate compounded by Specialty Compounding show growth of bacteria that are consistent with Rhodococcus species.

FDA is working closely with the Centers for Disease Control and Prevention (CDC) and the Texas state officials to investigate the cause of these bacterial infections.

BACKGROUND: Calcium gluconate by infusion can be used to treat conditions associated with low calcium levels in certain circumstances.

RECOMMENDATION: FDA is alerting health care professionals not to use any sterile products supplied by Specialty Compounding, Cedar Park, TX.
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 FDA statement, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

Specialty Compounding, Cedar Park, TX製造之葡萄糖酸鈣輸注液可能受到汙染，並可能產生細菌感染。

FDA接獲15則副作用報告。此15名病人使用由Specialty Compounding配製之葡萄糖酸鈣輸注液後，出現馬紅球菌(Rhodococcus equi)引起的菌血症。此感染被視為與輸注液有關。經由葡萄糖酸鈣之完整取樣培養，顯示其菌種為紅球菌(Rhodococcus species)。

FDA目前正與疾病管制局(CDC)及德州政府密切調查造成細菌感染的原因。

背景：葡萄糖酸鈣輸注液可被用於治療某些情況下之低血鈣症。

建議：FDA提醒醫療人員先不要使用任何由Specialty Compounding, Cedar Park, TX供應之無菌製劑。
 

相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

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