Fluconazole Pregnancy and Breast Feeding Warnings
Fluconazole is also known as: Diflucan
Overview
If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fluconazole Solution while you are pregnant. Fluconazole Solution is found in breast milk. If you are or will be breast-feeding while you use Fluconazole Solution, check with your doctor. Discuss any possible risks to your baby.
Fluconazole Pregnancy Warnings
Fluconazole has been assigned to pregnancy category C by the FDA. High-dose animal studies have revealed evidence of embryolethality, fetotoxicity and teratogenicity. There are no controlled data in human pregnancies. However, in a retrospective study, there was no overall increased risk of congenital malformations after exposure to short-course treatment with fluconazole in early pregnancy. Fluconazole should only be given during pregnancy when there are no alternatives and benefit outweighs risk.
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 Lactation Warnings
Fluconazole is excreted into human milk in relatively high concentrations. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
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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