FDA Says Chronic, High-Dose Fluconazole Use Might Carry Risk for Birth Defects

Long-term, high-dose use of the antifungal fluconazole (Diflucan) could cause rare birth defects if taken during the first trimester of pregnancy, the FDA warned Wednesday. The risk is only associated with 400- to 800-mg daily doses and not with the single-dose pill (150 mg).

The agency based its warning on published reports in which infants who were exposed in utero to high-dose fluconazole in the first trimester were born with rare congenital anomalies such as brachycephaly, oral cleft, joint deformities, and congenital heart disease.

In response to the findings, the drug's pregnancy category — when indicated for life-threatening fungal infections that require high doses — has been changed from C to D. The pregnancy category has not changed for the single 150-mg dose used to treat vaginal candidiasis.