Elsevier

The Journal of Pediatrics

Volume 160, Issue 1, January 2012, Pages 33-37.e2
The Journal of Pediatrics

Original Article
Central Nervous System Depression of Neonates Breastfed by Mothers Receiving Oxycodone for Postpartum Analgesia

https://doi.org/10.1016/j.jpeds.2011.06.050Get rights and content

Objective

To quantify the incidence of central nervous system (CNS) depression in neonates breastfed by mothers medicated with oxycodone as compared with neonates whose breastfeeding mothers used codeine or acetaminophen only.

Study design

We retrospectively compared 3 cohorts in 533 breastfeeding mother-infant pairs exposed to oxycodone (n = 139), codeine (n = 210), or acetaminophen only (n = 184). Standardized questionnaires were administered to mothers during the postpartum period to identify maternal and neonatal health outcomes temporally related to analgesia exposure.

Results

Maternal exposure to oxycodone during breastfeeding was associated with a 20.1% rate of infant CNS depression (28/139) compared with 0.5% in the acetaminophen group (1/184; P < .0001; OR, 46.16; 95% CI, 6.2-344.2) and 16.7% in the codeine group (35/210; P > .05; OR, 0.79; 95% CI, 0.46-1.38). Mothers of neonates with symptoms in the oxycodone and codeine cohorts took significantly higher doses of medication compared with mothers of infants with no symptoms in the same cohorts (P = .0005 oxycodone; median, 0.4 mg/kg/day; range, 0.03-4.06 mg/kg/day versus median, 0.15 mg/kg/day; range, 0.02-2.25 mg/kg/day; codeine P < .001; median, 1.4 mg/kg/day; range, 0.7-10.5 mg/kg/day versus 0.9 mg/kg/day; range, 0.18-5.8 mg/kg/day). Mothers were significantly more likely to experience sedative adverse effects from oxycodone as compared with codeine (P < .0001; OR, 17.62; 95% CI, 9.95-31.21).

Conclusion

Oxycodone is not a safer alternative to codeine in breastfed infants.

Section snippets

Methods

A retrospective study consisting of 3 cohorts (breastfeeding mother-infant pairs exposed to oxycodone, codeine, or acetaminophen only) was conducted, after obtaining research ethics board approval from the Hospital for Sick Children (Toronto, Ontario, Canada). The mother-infant pairs were recruited from the Motherisk Program at the Hospital for Sick Children, a teratology information center that counsels women with evidence-based information about the safety of using medication during pregnancy

Results

We examined the files of 1560 women inquiring about oxycodone (n = 289), codeine (n = 681), or acetaminophen only (n = 590). Of these, 533 women were available for follow up (139 in the oxycodone cohort, 210 in the codeine cohort, and 184 in the acetaminophen-only group; Figure [available at www.jpeds.com]).

In the codeine group, 65% (137/210) of mothers were taking a combination codeine-acetaminophen product, and the rest were taking codeine alone (73/210). In the oxycodone group, 52.5%

Discussion

After a fatal case in a breastfed infant exposed to codeine through breast milk,7 both the US Food and Drug Administration and Health Canada published warnings indicating that codeine use in breastfeeding may not be safe for infants.10, 11 As a result, some institutions are now replacing codeine with oxycodone for postpartum pain relief. However, Seaton et al detected oxycodone in breast milk from all mothers taking any dose of oxycodone.1 The levels of oxycodone in breast milk strongly

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Supported by a Post Market Drug Safety and Effectiveness Catalyst grant awarded by the Drug Safety and Effectiveness Network of the Canadian Institutes of Health Research. The authors declare no conflicts of interest.

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