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藥物警訊(藥師週刊 第1740期)





Diflucan (fluconazole): Drug Safety Communication – Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects


AUDIENCE: OBGYN, Pharmacy, Infectious Disease

ISSUE: FDA is informing the public that treatment with chronic, high doses (400-800mg/day) of Diflucan (fluconazole) during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants. This risk does not appear to be associated with a single, low dose of fluconazole 150mg to treat vaginal yeast infection (candidiasis). Based on this information, the pregnancy category for fluconazole indications (other than vaginal candidiasis) has been changed from category C to category D. The pregnancy category for a single, low dose of fluconazole has not changed and remains category C.

BACKGROUND: Diflucan is used to treat yeast infections of the vagina, mouth, throat, esophagus and other organs. It is also used to prevent yeast infections in patients who are likely to become infected because they are being treated with chemotherapy or radiation therapy before bone marrow transplant. Diflucan is also used to treat meningitis caused by a certain type of fungus. Pregnancy category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women with serious or life-threatening conditions may be acceptable despite its risks.

RECOMMENDATION: Healthcare professionals should counsel patients if the drug is used during pregnancy or if a patient becomes pregnant while taking the drug. Patients should notify their healthcare professionals if they are or become pregnant while taking fluconazole. If a patient uses fluconazole during pregnancy, the patient should be informed of the potential risk to the fetus.

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:
* 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 Drug Safety Communication, at:

FDA通知大眾,懷孕第一期的婦女長期使用高劑量(400-800 mg/day)Diflucan(fluconazole]1,可能會造成罕見而明顯的新生兒缺陷。但因陰道念珠菌感染而使用單次、低劑量fluconazole 150 mg時,則無此風險。因此,fluconazole單次、低劑量使用於陰道念珠菌感染時,懷孕分級維持為C;但fluconazole應用於其他適應症 時,懷孕分級從C更改為D。

Diflucan被用於治療陰道、口腔、喉嚨、食道及其他器官的酵母菌感染;預防骨髓移植前接受化療或放療的病人得到酵母菌感染;治療特定型態的黴菌引起 的腦膜炎。懷孕分級D表示對於人類嬰兒的風險已被證實,但使用藥品的利益與風險在某些經過合理評估的情況下,或許仍可接受其風險。


相關訊息與連結請參考FDA網址: /SafetyAlertsforHumanMedicalProducts/ucm266468.htm
[Posted 08/03/2011]