Drugs in Pregnancy and Lactation: Tenth Edition

PAREGORIC

Antidiarrheal

PREGNANCY RECOMMENDATION: Human Data Suggest Risk

BREASTFEEDING RECOMMENDATION: Limited Human Data—Probably Compatible

PREGNANCY SUMMARY

Paregoric is a mixture of opium powder, anise oil, benzoic acid, camphor, glycerin, and ethanol. Its action is mainly caused by morphine (see also Morphine). High or chronic use near term could result in neonatal depression and/or withdrawal. There also is concern that exposure to opioids during organogenesis, including morphine, results in a low absolute risk of congenital anomalies.

FETAL RISK SUMMARY

Paregoric is indicated for the treatment of diarrhea. Animal reproduction studies have not been conducted with paregoric or morphine. Although long-term animal studies have not been conducted, paregoric has no known carcinogenic or mutagenic potential (1).

The Collaborative Perinatal Project monitored 50,282 mother–child pairs, 90 of whom had 1st trimester exposure to paregoric (2, pp. 287–295). For use anytime during pregnancy, 562 exposures were recorded (2, p. 434). No evidence was found to suggest a relationship to large categories of major or minor malformations or to individual defects.

BREASTFEEDING SUMMARY

The active component of paregoric, morphine, is thought to be compatible with breastfeeding (see Morphine). However, high doses or chronic use might have long-term effects on a nursing infant.

References

1.Product information. Paregoric. Hi-Tech Pharmacal, 2012.

2.Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA: Publishing Sciences Group, 1977.