Antifungal
PREGNANCY RECOMMENDATION: Human Data Suggest Low Risk
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
Although no published reports describing the use of terconazole in human pregnancy have been located, the FDA database provided information on a large number of exposures. This pregnancy experience, combined with the animal data, suggest that the embryo–fetal risk is low. However, additional human studies are required for confirmation.
FETAL RISK SUMMARY
Terconazole is available as either a vaginal cream or suppositories. The antifungal agent is absorbed into the systemic circulation in humans after vaginal administration. Fetal exposure to the drug is also possible by direct transfer of terconazole across the amniotic membranes after vaginal administration (1). Terconazole is a triazole antifungal agent in the same class as fluconazole, itraconazole, posaconazole, and voriconazole.
No evidence of teratogenicity was found after oral and SC administration of terconazole to rats and rabbits, but some embryotoxicity was observed at high doses (1).
In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 1167 newborns had been exposed to terconazole during the 1st trimester (F. Rosa, personal communication, FDA, 1993). A total of 34 (2.9%) major birth defects were observed (48 expected). Specific data were available for six defect categories, including (observed/expected) 14/12 cardiovascular defects, 0/2 oral clefts, 0/0.5 spina bifida, 3/3 polydactyly, 1/2 limb reduction defects, and 1/3 hypospadias. These data do not support an association between the drug and congenital defects.
BREASTFEEDING SUMMARY
No reports describing the use of terconazole during lactation have been located.
Reference
1.Product information. Terazol. Ortho Pharmaceutical, 1993.