Docusate has not been formally assigned to a pregnancy category by the FDA. Animal studies have not been reported. Based on the available data, docusate does not appear to be teratogenic.

Senna has been assigned to pregnancy category C. Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. Docusate-senna should only be given during pregnancy when benefit outweighs risk.

During the Collaborative Perinatal Project, 30 exposures to docusate during the first trimester, and 116 exposures to docusate anytime during pregnancy were recorded. Malformations were reported in 3 children (2.23 expected).

In a review of 229,101 deliveries to Michigan Medicaid patients during 1985 to 1992, 232 first-trimester exposures to docusate were recorded and 3003 exposures anytime during pregnancy. A total of 9 birth defects were reported with first trimester exposure (9 expected) and included 1 cardiovascular defect and 1 case of polydactyly. Review of 6589 first trimester exposures in a previous review of data from 1980 to 1983 also revealed no association between docusate and congenital abnormalities. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994)

A published report of 35 women exposed to docusate and dihydroxyanthraquinone also revealed no association between docusate and adverse fetal outcome.

See references

In one study of 35 women receiving in combination of docusate and dihydroxyanthraquinone, diarrhea was reported in one nursing infant.

There are no data on the excretion of docusate into human milk. Diarrhea has been described in nursing infants. Senna is not excreted into human milk. However, senna is a prodrug which is metabolized in vivo to the active sennosides (glucosides of rhein). Rhein is excreted into human milk in very small amounts. No adverse effects have been observed in nursing infants. The American Academy of Pediatrics considers senna to be compatible with breast-feeding.

See references