Effects of codeine on pregnancy outcome: results from a large population-based cohort studyReport as inadecuate

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European Journal of Clinical Pharmacology

, Volume 67, Issue 12, pp 1253–1261

First Online: 09 June 2011Received: 24 January 2011Accepted: 23 May 2011


BackgroundGuidelines on codeine safety during pregnancy rely on small studies with inconsistent results, and associations between codeine use during pregnancy and increased risk of congenital malformations remain unsubstantiated.

ObjectivesOur objective was to analyze the effect of codeine on pregnancy outcome.

MethodsPregnancy outcomes of 2,666 women who used codeine during pregnancy were compared with 65,316 women who used no opioids during pregnancy. Information on maternal sociodemographic and medical characteristics, potential confounders, and pregnancy outcome was obtained from The Norwegian Mother and Child Cohort Study den norske Mor and barn-undersøkelsen MoBa data set and the Medical Birth Registry of Norway MBRN data set. The data sets were linked via the maternal personal identification number. Associations between codeine therapy and pregnancy outcomes were identified using logistic regression analyses.

ResultsNo significant differences were found in the survival rate adjusted odds ratio OR 0.9, 95% confidence interval CI 0.6–1.5 or the congenital malformation rate adjusted OR 0.9, 95% CI 0.8–1.1 between codeine-exposed and unexposed infants. Codeine use anytime during pregnancy was associated with planned Cesarean delivery adjusted OR 1.4, 95% CI 1.2–1.7; P < 0.0001. Third-trimester use was associated with acute Cesarean delivery adjusted OR 1.5, 95% CI 1.3–1.8; P < 0.0001 and postpartum hemorrhage adjusted OR 1.3, 95% CI 1.1–1.5; P < 0.0001. No significant associations with other adverse pregnancy outcomes were found.

ConclusionsNo effects of maternal codeine intake during pregnancy were observed on infant survival or congenital malformation rate. Our findings are reassuring; however, the association with acute Cesarean delivery and postpartum hemorrhage may justify a certain level of caution when administering codeine toward the end of pregnancy.

KeywordsCodeine Delivery complications Pregnancy outcome Electronic supplementary materialThe online version of this article doi:10.1007-s00228-011-1069-5 contains supplementary material, which is available to authorized users.

An erratum to this article can be found at http:-dx.doi.org-10.1007-s00228-012-1434-z.

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Author: Kateřina Nezvalová-Henriksen - Olav Spigset - Hedvig Nordeng

Source: https://link.springer.com/

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