NYSTATIN

Fetal Risk Summary

Nystatin is poorly absorbed after oral administration and from intact skin and mucous membranes. Animal studies have not been conducted with this antifungal agent.

The Collaborative Perinatal Project found a possible association with congenital malformations after 142 1st-trimester exposures, but this was probably related to its use as an adjunct to tetracycline therapy (1, p. 313). No association was found following 230 exposures anytime in pregnancy (1, p. 435). Other investigators have reported its safe use in pregnancy (2,3,4 and 5).

In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 489 newborns had been exposed to nystatin during the 1st trimester (F. Rosa, personal communication, FDA, 1993). A total of 20 (4.1%) major birth defects were observed (21 expected). Specific data were available for six defect categories, including (observed/expected) 3/5 cardiovascular defects, 1/1 oral clefts, 0/0 spina bifida, 1/1 polydactyly, 1/1 limb reduction defects, and 2/1 hypospadias. These data do not support an association between the drug and congenital defects.

Breast Feeding Summary

Because nystatin is poorly absorbed, if at all, serum and milk levels would not occur.

References

1. Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA: Publishing Sciences Group, 1977.
2. Culbertson C. Monistat: a new fungicide for treatment of vulvovaginal candidiasis. Am J Obstet Gynecol 1974;120:973–6.
3. David JE, Frudenfeld JH, Goddard JL. Comparative evaluation of Monistat and Mycostatin in the treatment of vulvovaginal candidiasis. Obstet Gynecol 1974;44:403–6.
4. Wallenburg HCS, Wladimiroff JW. Recurrence of vulvovaginal candidosis during pregnancy. Comparison of miconazole vs nystatin treatment. Obstet Gynecol 1976;48:491–4.
5. Rosa FW, Baum C, Shaw M. Pregnancy outcomes after first-trimester vaginitis drug therapy. Obstet Gynecol 1987;69:751–5.