Risk Factor: C
Class: Gastrointestinal agents/ Antiemetics
Fetal Risk Summary
Buclizine is a piperazine antihistamine that is used as an antiemetic (see also Cyclizine and Meclizine for closely related drugs). The drug is teratogenic in animals, but its effects on the human fetus have not been thoroughly studied.
The Collaborative Perinatal Project monitored 50,282 mother-child pairs, 44 of whom had 1st trimester exposure to buclizine (1, pp. 323324). No evidence was found to suggest a relationship to large categories of major or minor malformations. For use anytime during pregnancy, 62 exposures were recorded (1, p. 437). A possible association with congenital defects, based on the report of three malformed children, was found from this exposure. The manufacturer considers the drug to be contraindicated in early pregnancy (2).
An association between exposure during the last 2 weeks of pregnancy to antihistamines in general and retrolental fibroplasia in premature infants has been reported. See Brompheniramine for details.
Breast Feeding Summary
No data are available.
- Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA:Publishing Sciences Group, 1977.
- Product information. Bucladin. Stuart Pharmaceuticals, 1990.