TERCONAZOLE

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 (1). Fetal exposure to the drug is also possible by direct transfer of terconazole across the amniotic membranes after vaginal administration (1).

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). No published reports describing the use of terconazole in human pregnancy have been located.

In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 1,167 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.

Breast Feeding Summary

No data are available.

Reference