Risk Factor: D
Class: Central nervous system drugs/ Anticonvulsants
Fetal Risk Summary
Ethotoin is a low-potency hydantoin anticonvulsant (1). The fetal hydantoin syndrome has been associated with the use of the more potent phenytoin (see Phenytoin). Only six reports describing the use of ethotoin during the 1st trimester have been located (2,3 and 4). Congenital malformations observed in two of these cases included cleft lip/palate and patent ductus arteriosus (3,4). No cause-and-effect relationship was established. Although the toxicity of ethotoin appears to be lower than the more potent phenytoin, the occurrence of congenital defects in two fetuses exposed to ethotoin suggests that a teratogenic potential may exist.
Breast Feeding Summary
No data are available.
- Schmidt RP, Wilder BJ. Epilepsy. In Contemporary Neurology Services. Volume 2. Philadelphia, PA:FA Davis Co, 1968:154.
- Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA:Publishing Sciences Group, 1977:3589.
- Zablen M, Brand N. Cleft lip and palate with the anticonvulsant ethantoin. N Engl J Med 1978;298:285.
- Nakane Y, Okuma T, Takahashi R, et al. Multi-institutional study on the teratogenicity and fetal toxicity of antiepileptic drugs: a report of a collaborative study group in Japan. Epilepsia 1980;21:66380.