DOCUSATE SODIUM

Fetal Risk Summary

No reports linking the use of docusate sodium (DSS) with congenital defects have been located. DSS is a common ingredient in many laxative preparations available to the public. In a large prospective study, 116 patients were exposed to this drug during pregnancy (1). No evidence for an association with malformations was found. Similarly, no evidence of fetal toxicity was noted in 35 women treated with a combination of docusate sodium and dihydroxyanthraquinone (2).

In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 232 newborns had been exposed to a docusate salt during the 1st trimester (F. Rosa, personal communication, FDA, 1993). Nine (3.9%) major birth defects were observed (nine expected), including one cardiovascular defect (two expected) and one polydactyly (one expected). No anomalies were observed in four other categories of defects (oral clefts, spina bifida, limb reduction defects, and hypospadias) for which specific data were available. These data do not support an association between the drug and congenital defects.

Chronic use of 150–250 mg/day or more of docusate sodium throughout pregnancy was suspected of causing hypomagnesemia in a mother and her newborn (3). At 12 hours of age, the neonate exhibited jitteriness, which resolved spontaneously. Neonatal serum magnesium levels ranged from 0.9–1.1 mg/dL between 22–48 hours of age with a maternal level of 1.2 mg/dL on the 3rd postpartum day. All other laboratory parameters were normal.

Breast Feeding Summary

A combination of docusate sodium and dihydroxyanthraquinone (Normax) was given to 35 postpartum women in a 1973 study (2). One infant developed diarrhea, but the relationship between the symptom and the laxative is unknown.

References

1. Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA:Publishing Sciences Group, 1977:442.
2. Greenhalf JO, Leonard HSD. Laxatives in the treatment of constipation in pregnant and breast-feeding mothers. Practitioner 1973;210:259–63.
3. Schindler AM. Isolated neonatal hypomagnesaemia associated with maternal overuse of stool softener. Lancet 1984;2:822.