From the
AAP News:
Chronic, high doses (400 mg/day) of the antifungal drug Diflucan (fluconazole) may be associated with a rare and distinct set of birth defects in infants whose mothers were treated with the drug during the first trimester of pregnancy, according to the Food and Drug Administration (FDA).
The risk does not appear to be associated with a single, low dose of fluconazole (150 mg) to treat vaginal candidiasis.
Based on the information, the FDA changed the pregnancy category for fluconazole indications other than vaginal candidiasis from category C to category D. That means there is positive evidence of human fetal risk based on human data, though potential risks from use of the drug in pregnant women with serious or life-threatening conditions may be acceptable despite the risks.