High-dose fluconazole becomes pregnancy category D
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High-dose fluconazole becomes pregnancy category D Chronic use of high-dose fluconazole [Diflucan] during the first trimester of pregnancy may increase the risks of particular birth defects, warns the US FDA. The FDA cites five case reports, published in the medical literature, describing congenital abnormalities in infants whose mothers were receiving chronic fluconazole 400–800 mg/day for fungal infections. Four reports involved maternal use of IV fluconazole to treat coccidioidal meningitis, while the other report involved chronic use of high-dose oral fluconazole in an HIVpositive mother for the treatment of vaginal candidiasis. The abnormalities all shared characteristics with AntleyBixler syndrome. Available data do not suggest any link between congenital abnormalities and the use of single, low dose (150mg) oral fluconazole for the treatment of vaginal candidiasis. The FDA has changed fluconazole’s pregnancy category from C to D for indications other than vaginal candidiasis. Single dose 150mg oral fluconazole to treat vaginal candidiasis remains category C. FDA. Diflucan (fluconazole): Drug Safety Communication -- Long-term, Highdose Use During Pregnancy May Be Associated With Birth Defects. Internet Document : [2 pages], 3 Aug 2011. Available from: URL: http:// 801085428 www.fda.gov
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Reactions 13 Aug 2011 No. 1364
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