引 致 更 改 給 病 人 的 產 品 資 訊 的 藥 物 不 良 反 應 警 示
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| The United States: Diflucan (fluconazole): Drug Safety Communication – long-term, high-dose use during pregnancy may be associated with birth defects (English Only) |
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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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm266468.htm
In Hong Kong, Diflucan (fluconazole) is registered by Pfizer Corporation HK Ltd. and there are a total of 65 fluconazole-containing products registered and all are prescription medicines. In view of FDA's recommendation, a letter to inform healthcare professionals will be issued and the matter will be discussed in the coming meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Thursday, August 4, 2011
Issued at HKT 15:00
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