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Casanthranol / docusate Pregnancy and Breastfeeding Warnings

Brand names: Aqualax Forte, DSMC Compound Plain, DSS Plus, Diocto-C, Diocto-K Plus, Dioctolose, Docu Soft Plus, Doculax Plus, Doxidan, Genasoft Plus, Octycine, Perestan, Peri-DOS, Peri-DS, Strong Caps

Casanthranol / docusate Pregnancy Warnings

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.

Hypomagnesemia was discovered within 22 hours of birth in one neonate whose mother had used docusate, 100 mg per day or more, chronically throughout pregnancy. The mother also exhibited hypomagnesemia until docusate use was discontinued.

Casanthranol has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. 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. Casanthranol-docusate is only recommended for use during pregnancy when benefit outweighs risk.

See references

Casanthranol / docusate Breastfeeding Warnings

Casanthranol is excreted into human milk. There are no data on the excretion of docusate into human milk. Diarrhea has been described in nursing infants.

Anthraquinone derivatives, for example casanthranol, are excreted in human breast milk and may potentially increase the incidence of diarrhea in the nursing infant.

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

See references

References for pregnancy information

  1. Heinonen O, Shapiro S; Kaufman DW ed., Slone D. Birth Defects and Drugs in Pregnancy. Littleton, MA: Publishing Sciences Group, Inc. 1977;297.
  2. Schindler AM. Isolated neonatal hypomagnesaemia associated with maternal overuse of stool softener Lancet. 1984;2:822.
  3. Greenhalf JO, Leonard HS. Laxatives in the treatment of constipation in pregnant and breast-feeding mothers. Practitioner. 1973;210:259-63.

References for breastfeeding information

  1. Greenhalf JO, Leonard HS. Laxatives in the treatment of constipation in pregnant and breast-feeding mothers. Practitioner. 1973;210:259-63.

Further information

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