Chronic high doses (400 mg/day to 800 mg/day) of fluconazole (Diflucan, Pfizer) taken by women during the first trimester of pregnancy may be associated with specific birth defects in infants.
The risk does not appear to be associated with the single low dose of fluconazole (150 mg) that is used to treat yeast infection.
The safety alert is based on several published case reports of birth defects in infants whose mothers were treated with high doses of fluconazole for serious and life-threatening fungal infections during most or all of the first trimester.
As a result of these data, the pregnancy category for fluconazole indications has been changed from category C to category D.
Providers should counsel patients if the medicine is used during pregnancy or if a patient becomes pregnant while taking this medicine.
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