CASANTHRANOL

Fetal Risk Summary

Casanthranol is an anthraquinone purgative. In a large prospective study, 109 patients were exposed to this agent during pregnancy, 21 in the 1st trimester (1). No evidence of an increased risk for malformations was found (see also Cascara Sagrada).

In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 96 newborns had been exposed to casanthranol during the 1st trimester (F. Rosa, personal communication, FDA, 1993). Four (4.2%) (four expected) major birth defects were observed. Specific data were available for six defect categories, including (observed/expected) 2/1 cardiovascular defects, 1/0 spina bifida, and 1/0.5 polydactyly. No anomalies were observed in the other three categories (oral clefts, limb reduction defects, and hypospadias). These data do not support an association between the drug and congenital defects.

Breast Feeding Summary

See Cascara Sagrada.

Reference