VIDARABINE

Fetal Risk Summary

Vidarabine is a potent teratogen in some species of animals after topical and IM administration (1,2). Daily instillations of a 10% solution into the vaginas of pregnant rats in late gestation had no effect on the offspring (2).

Vidarabine was used for disseminated herpes simplex in one woman at about 28 weeks' gestation (3,4). Spontaneous rupture of the membranes occurred 48 hours after initiation of therapy, and a premature infant was delivered. The infant died on the 13th day of life of complications of prematurity. In a second case, a woman at 32 weeks' gestation with herpes simplex type II encephalitis was treated with vidarabine, 10 mg/kg/day, and acyclovir (5). A female infant with culture-documented herpes neonatorum was delivered by cesarean section 13 days later. The infant responded to further treatment with acyclovir and is alive and well at 2 months of age, but the mother died 2 days after delivery.

Vidarabine, 10 mg/kg/day (800 mg/day), was administered to a woman at 26 weeks' gestation with varicella pneumonitis (6). Peak and trough levels of the agent were 12.8 and 2.7 µg/mL, respectively. She delivered a healthy female infant at 38 weeks' gestation who is developing normally at 12 months of age. In a similar case, another woman with varicella pneumonitis at 27 weeks' gestation was treated with vidarabine (6). Except for a delay in speech at age 3 years that responded to special education, the child has done well and was considered normal at 5 years.

Breast Feeding Summary

No reports involving the use of vidarabine in lactating women have been located. It is not known whether the drug is excreted into milk.

References

1. Pavan-Langston D, Buchanan RA, Alford CA Jr, eds. Adenine Arabinoside: An Antiviral Agent. New York, NY: Raven Press, 1975:153.
2. Schardein JL, Hertz DL, Petretre JA, Fitzgerald JE, Kurtz SM. The effect of vidarabine on the development of the offspring of rats, rabbits and monkeys. Teratology 1977;15:213–42.
3. Hillard P, Seeds J, Cefalo R. Disseminated herpes simplex in pregnancy: two cases and a review. Obstet Gynecol Surv 1982;37:449–53.
4. Peacock JE Jr, Sarubbi FA. Disseminated herpes simplex virus infection during pregnancy. Obstet Gynecol 1983;61:13S–8S.
5. Berger SA, Weinberg M, Treves T, Sorkin P, Geller E, Yedwab G, Tomer A, Rabey M, Michaeli D. Herpes encephalitis during pregnancy: failure of acyclovir and adenine arabinoside to prevent neonatal herpes. Isr J Med Sci 1986;22:41–4.
6. Landsberger EJ, Hager WD, Grossman JH III. Successful management of varicella pneumonia complicating pregnancy: a report of three cases. J Reprod Med 1986;31:311–4.