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Fluconazole Pregnancy and Breastfeeding Warnings

Fluconazole is also known as: Diflucan

Fluconazole Pregnancy Warnings

Several epidemiologic studies do not indicate an increased risk of congenital anomalies associated with low dose exposure to fluconazole during pregnancy (most patients received a single 150 mg oral dose). A few cases of a distinctive and rare pattern of birth defects have been reported in infants exposed in utero to high dose maternal fluconazole (400 to 800 mg/day) during most or all of the first trimester. Brachycephaly, abnormal facies, abnormal calvarial development, cleft palate, femoral bowing, thin ribs and long bones, arthrogryposis, and congenital heart disease have been observed in these infants. These effects are similar to those observed in animal studies. Patients should be advised of the potential risk to the fetus if they become pregnant while taking fluconazole or if it is administered during pregnancy. A malformed infant girl was born prematurely to a woman who received fluconazole 400 mg per day throughout pregnancy for disseminated coccidioidomycosis. The infant displayed cranioschisis of the frontal bones, craniostenosis of the sagittal suture, hypoplasia of the nasal bones, cleft palate, humoral-radial fusion, bowed tibia and femur, bilateral femoral fractures, contractures of both upper and lower extremities, and defects of the fingers and toes. The infant died shortly after birth. Two additional cases of congenital malformations have been reported in infants born to women receiving fluconazole during or beyond the first trimester of pregnancy. Craniofacial, skeletal and cardiac malformations were evident. Only one infant survived. A 24-year-old pregnant woman at week 16 of gestation was treated with fluconazole for Candida albicans sepsis. She received fluconazole 10 mg/kg for a total of 50 days. Following treatment for sepsis, the remainder of her pregnancy took a normal course. At week 39 gestation she delivered a healthy female with no signs of congenital abnormalities. At two years of age, the baby showed normal growth and mental development. In a retrospective population-based study in Northern Denmark, 1079 women who had a live birth or a stillbirth after the 20th week of gestation and who redeemed at least one prescription for fluconazole during the first trimester were compared to a cohort comprised of 170,453 pregnant women who redeemed no fluconazole prescription during pregnancy. The women were selected through the Danish Medical Birth Registry. Data on medication use, birth outcome and covariates were extracted from population-based healthcare databases. Among 1079 women who filled a fluconazole prescription during the first trimester, 797 (74%) received a total of 150 mg of fluconazole, 235 (22%) received 300 mg of fluconazole, 24 (2%) received 350 mg of fluconazole, and 23 (2%) received 600 mg of fluconazole. These women gave birth to 44 (4.1%) children with congenital malformations. The 170,453 women without fluconazole prescriptions gave birth to 6152 (3.6%) children with congenital malformations. The study found no overall increased risk of congenital malformations after exposure to short-course treatment with fluconazole in early pregnancy.

Fluconazole 150 mg single tablet treatment of vaginal candidiasis has been assigned to pregnancy category C by the FDA. For all other indications, fluconazole has been assigned to pregnancy category D by the FDA. High-dose animal studies have revealed evidence of embryolethality, fetotoxicity, and teratogenicity. There are no controlled data in human pregnancy. Available human data do not indicate an increased risk of congenital anomalies after a single maternal dose of 150 mg. A few cases of a rare pattern of distinct congenital anomalies in infants exposed in utero to high dose maternal fluconazole (400 to 800 mg/day) during most or all of the first trimester has been reported. Fluconazole is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Fluconazole Breastfeeding Warnings

Fluconazole is excreted into human milk. The effects in the nursing infant are unknown. The manufacturer recommends that caution be used when administering fluconazole to nursing women.

Fluconazole is excreted in human milk at concentrations similar to maternal plasma levels. A nursing woman who received a single dose of fluconazole 150 mg orally to treat vaginal candidiasis had breast milk:plasma ratios of 0.46, 0.85, 0.85, and 0.83 at 2, 5, 24, and 48 hours, respectively, indicating relatively high concentrations of drug in the breast milk. The use of fluconazole has been documented in at least 2 neonates at a dosage of 6 mg/kg. One infant developed a small, transient elevation in liver function tests which resolved with a dosage reduction. These cases suggest fluconazole may be safely used during breast-feeding, as infants would receive significantly less drug. However, more experience is necessary to establish safety.

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