Voriconazole Pregnancy and Breastfeeding Warnings

Voriconazole is also known as: Vfend

Voriconazole Pregnancy Warnings

Voriconazole has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of teratogenicity and embryolethality at doses ranging from 0.3 to 6 times (when adjusted for body surface area) the recommended maintenance dose. There are no controlled data in human pregnancy. Voriconazole can cause fetal harm when administered to a pregnant patient. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should use effective contraception during treatment.

Voriconazole caused cleft palates, hydronephrosis and hydroureter in the offspring of rats when administered to pregnant females at a dose of 10 mg/kg (0.3 times the recommended maintenance dose on a mg/m2 basis). It was embryotoxic when administered to rabbits at a dose of 100 mg/kg (6 times the recommended maintenance dose on a mg/m2 basis). Other teratogenic effects in rats included reduced ossification of sacral and caudal vertebrae, skull, pubic and hyoid bone. Dilation of the ureter/renal pelvis was also observed. In the pregnant rats, decreased plasma estradiol levels were observed. The effects seen in rabbits included an increased embryolethality, reduced fetal weight and increased incidences of skeletal variations, cervical ribs and extra sternebral ossification sites.

Voriconazole Breastfeeding Warnings

There are no data on the excretion of voriconazole into human milk. 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.

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