藥物警訊（藥師週刊 第1735期）

Coumadin (warfarin sodium) Crystalline 5 mg Tablets: Recall - Tablets May Have Higher than Expected Potency

AUDIENCE: Cardiology, Pharmacy, Patients

Bristol-Myers Squibb initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin (warfarin sodium) Crystalline 5 mg tablets. Company testing of tablets from a returned bottle found a tablet to be higher in potency than expected. The lot number affected in the U.S. is 9H49374A with an expiry date of September 30, 2012. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke, and if there is too much active ingredient, there is an increased risk of bleeding.

BACKGROUND: Coumadin is prescribed to treat or prevent blood clots.

RECOMMENDATION: Patients who may have 5 mg tablets should not interrupt their therapy but should seek advice from their pharmacist to see if they have tablets originating from the affected lot and if so, should consult their physician for appropriate medical advice.

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 company Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

因為一批Coumadin (warfarin sodium) 5 mg/粒,1000 粒/瓶的藥品，被檢驗出效價高於標示含量，所以必治妥施貴寶股份有限公司(Bristol-Mayers Squibb)自主回收批號9H49674A，效期為2012/09/30的藥品。Coumadin是用來治療或預防血栓的藥物，若是效價低於標示含量，可能會提高發生血栓的機率，進而導致心臟病發或中風；若是高於標示含量，則可能會增加出血的機率。

建議正在服用Coumadin 5 mg的病人不可擅自中斷治療，應先向藥師確認服用的是否為該批號的藥品。如果是，則應尋求醫師的建議。

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation /SafetyAlertsforHumanMedicalProducts/ucm253615.htm
[Posted 05/03/2011]

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