藥物警訊（藥師週刊 第1715期）

American Regent Injectable Products: Recall - Visible Particulates in Products

* Sodium Thiosulfate Injection USP 10%
* Potassium Phosphates Injection, USP

AUDIENCE: Pharmacy

Recall initiated because some vials exhibit translucent visible particles consistent with glass delamination. Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.

BACKGROUND: Glass delamination can occur with high pH solutions when the surface glass from the vial separates into thin layers, resulting in glass particles with a flaky appearance.

RECOMMENDATION: Hospitals, Home Health Care Agencies, Emergency Rooms, Infusion Centers, Clinics and other healthcare facilities should not use the recalled American Regent products. Recalled products should be immediately quarantined for return. Refer to Press Releases for specific lot numbers recalled.?

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, incljuding links to the company press releases, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

由於部分針劑發現肉眼可見的玻璃脫層，廠商初步回收Sodium Thiosulfate Injection USP 10%及Potassium Phosphates Injection, USP，若經靜脈注射可能發生潛在的不良反應事件，包含肺血管損傷、局部腫脹及形成肉芽腫。

玻璃脫層可能發生於高pH值溶液下，當玻璃表面分離成薄層，即會造成玻璃有片狀外觀。

FDA建議醫院、居家照護機構、急診室、輸液中心、診所及其他醫療機構不應使用回收的美國Regent公司產品，且產品應立即退回，回收產品為Sodium Thiosulfate Injection, USP, 10% (100 mg/mL), 10 mL Single Dose Vial，NDC # 0517-1019-05，產品批號0056，有效期限2012年1月；及Potassium Phosphates Injection, USP, 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium 5 mL Single Dose Vial，NDC # 0517-2305-25，產品批號0048，有效期限2012年1月。

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm242365.htm
[Posted 02/05/2011]

Warfarin Sodium Tablets (Jantoven), 3 mg: Recall - Mislabeled Bottles Containing Higher Dosage

AUDIENCE: Pharmacy, Family Practice, Consumer

Upsher-Smith Laboratories and FDA notified healthcare professionals of the recall of one lot of Jantoven Warfarin Sodium, USP, 3mg Tablets, an anticoagulant, after a single bottle labeled as Jantoven Warfarin Sodium, USP, 3mg Tablets was found to contain tablets at a higher 10mg strength. To date, the company has identified no additional mislabeled bottles.?

BACKGROUND: The recalled lot is numbered as #284081, with an expiration date of September 2012. The product lot was distributed to wholesalers, retail chains and independent pharmacies throughout the United States. The primary risk of substituting 10mg warfarin for 3mg warfarin is overdosing more than 3 times the labeled amount which leads to excessive anticoagulation that could be expected to result in life-threatening hemorrhage in patients.???

RECOMMENDATION: The two Jantoven tablets (see photo at link below) can be readily identified by color: the 3mg tablet is tan and the 10mg tablet is white.?In addition, the 3mg tablet is imprinted with the letters WRF, a line, and the number 3 below the line.?The reverse side of the 3mg tablet carries the number 832.?The 10mg tablet is imprinted with the letters WRF, a line, and the number 10 below the line.?The reverse side of the 10mg tablet carries the number 832. Consumers and pharmacists can call the Upsher-Smith medical information line at 1-888-650-3789 for more information and to access product details, Monday-Friday between 8:00 a.m. and 5:00 p.m. (CST).

Healthcare professionals and patients are encouraged to report adverse events,?side effects, or product quality problems?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 links to the company press release and product photos, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

Upsher-Smith實驗室及FDA提醒醫護人員回收一批次的抗凝血劑Jantoven Warfarin Sodium, USP, 3 mg Tablets，因為發現其中一瓶包裝標示為Jantoven Warfarin Sodium, USP, 3 mg Tablets，但內含10 mg的藥品，至今，未發現有其他錯標產品。

回收的批號為284081，效期2012年9月，販售至全美的批發商、零售店及藥局，10 mg 錯標成3 mg的主要危險是超過3倍標示量可能導致過度抗凝血效果而造成致命性出血。

Jantoven兩種劑量藥品可以由顏色明確分辨，3 mg為棕色，10 mg為白色，另外，3 mg錠劑一字刻痕上印有WRF字樣，下印有數字3，另一面印有832，10 mg錠劑一字刻痕上印有WRF字樣，下印有數字10，另一面印有832，消費者及藥師可打Upsher-Smith的藥物諮詢專線詢問更多資訊。

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm243850.htm
[Posted 02/17/2011]

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