Citalopram And Finasteride by Greenstone: Recall - Possible Mislabeling
AUDIENCE: Risk Manager, Pharmacy, Family Practice
Greenstone LLC announced a recall of medicines with lot number FI0510058-A on the label. Bottles labeled as Citalopram (used to treat depression) may contain Finasteride (used for the treatment of benign prostatic hyperplasia). Women who are, or may become pregnant, should not take or handle Finasteride due to the possible risk of side effects which may cause abnormalities to the external genitalia of a developing male fetus. Citalopram is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or pimozide;?it is also contraindicated in patients with a hypersensitivity to Citalopram or any of the inactive ingredients in the tablet. Patients who discontinue Citalopram abruptly by inadvertently taking the mislabeled product may experience discontinuation symptoms and/or worsening of depression.
BACKGROUND: This includes Citalopram 10mg Tablets (100-count bottle) and Finasteride 5mg Tablets (90-count bottle), both distributed in the U.S. market. The recall is due to the possibility that incorrect labels have been placed on the bottles by a third-party manufacturer.
RECOMMENDATION: Bottles of either Citalopram or Finasteride with lot number FI050058-A should be returned. Patients who believe they may have ingested the wrong medication should contact their physician as soon as possible.
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...
Greenstone LLC公司宣佈回收批號F10510058-A的藥品，此批藥品標示是用來治療憂鬱的citalopram，但卻可能含有用來治療良性攝護腺肥大的 finasteride。懷孕或可能懷孕的婦女不應服用或碰觸finasteride，因為可能會使男胎兒的外生殖器發育不正常，citalopram對於正在使用monoamine oxidase inhibitors (MAOIs)或pimozide的病人是禁忌；對citalopram或其賦形劑過敏的人也是禁忌。服用此標示錯誤的產品會使病人無意中突然中斷服用 citalopram，病人可能會有停藥症候群或是加重憂鬱。
這包括二項在美國上市的產品，citalopram 10 mg/tab (一百粒裝)及finasteide 5 mg/tab (90粒裝)，而可能是因為第三方製造廠誤植標示才導致回收藥品。
建議回收瓶身標示批號F1050058-A的citalopram或finasteride的藥品，且認為服用了錯誤藥品的病人應儘快的聯繫醫師。
相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation /SafetyAlertsforHumanMedicalProducts/ucm248595.htm
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm248595.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 |
資料來源：藥師週刊 第1725期