The FDA is informing the public that chronic therapy with high-doses of Diflucan (fluconazole; Pfizer) may be associated with a rare and distinct set of birth defects in infants whose mothers were treated in the first trimester of pregnancy. There are several published case reports that describe congenital anomalies in infants whose mothers were treated with chronic high-dose (400800 mg/day) fluconazole for fungal infections in the first trimester of pregnancy. The birth defects observed include: short, broad head; abnormal looking face; oral cleft; bowing of the thigh bones; thin ribs and long bones; muscle weakness and joint deformities; and congenital heart disease.

This risk does not appear to be associated with a single, low dose of fluconazole 150mg to treat vaginal 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 remains Category C.

Diflucan is an azole antifungal indicated for the treatment of oropharyngeal, esophageal, systemic candidiasis; for use in bone marrow transplant prophylaxis; cryptococcal meningitis; candida urinary tract infection; peritonitis; and vaginal candidiasis.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm266468.htm.