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Codeine

Selected References:

  • Akhigbe RE, et al. 2022. Codeine alters female reproductive function by targeting ovarian steroidogenesis and folliculogenesis via the induction of oxidative stress, inflammation, and apoptosis, Reproductive Toxicology 109: 1-9.  
  • Azuine RE, et al. 2019. Prenatal risk factors and perinatal and postnatal outcomes associated with maternal opioid exposure in an urban, low-income, multiethnic US population. JAMA network 2(6): e196405-196405.  
  • Berlin CM, Jr, et al. 2009. Safety issues of maternal drug therapy during breastfeeding. Clinical pharmacology and therapeutics  85(1): 20-22. 
  • Bowie, AC, et al. 2022. Prescribed opioid analgesics in early pregnancy and the risk of congenital anomalies: a population-based cohort study. CMAJ. 194(5): E152-E162. 
  • Bracken MB. 1986. Drug use in pregnancy and congenital heart disease in offspring. N Engl J Med. 314(17):1120. 
  • Bracken MB, Holford TR. 1981. Exposure to prescribed drugs in pregnancy and association with congenital malformations. Obstet Gynecol. 58(3):336-344. 
  • Brogly SB, et al. 2021. Prenatal opioid analgesics and the risk of adverse birth outcomes. Epidemiology. 32(3), 448–456. 
  • Brogly SB, et al. 2023. Safety of prenatal opioid analgesics: Do results differ between public health insurance beneficiary and population-based cohorts? Birth Defects Res. 115(5):555-562. 
  • Broussard CS, et al. 2011. Maternal treatment with opioid analgesics and risk for birth defects. Am J Obstet Gynecol. 204(4):314.e1-11.
  • Corsi DJ, et al. 2020. Association of Maternal opioid use in pregnancy with adverse perinatal outcomes in Ontario, Canada, From 2012 to 2018. JAMA Netw Open. 3(7):e208256. 
  • Corsi DJ, et al. 2021. The effects of opioids on female fertility, pregnancy and the breastfeeding mother‐infant dyad: A Review. Basic Clin Pharmacol Toxicol. 128(5):635-641. 
  • Esposito, DB, et al. 2022. Characteristics of prescription opioid analgesics in pregnancy and risk of neonatal opioid withdrawal syndrome in newborns. JAMA Netw Open 5(8): e2228588. 
  • Fältmarch S, et al. 2019. Use of opioids during pregnancy and effects of pregnancy outcomes. Pharmacoepidemiol Drug Saf. 28: 1239– 1245.  
  • Fishman B, et al. 2019. Pregnancy outcome following opioid exposure: A cohort study. PLOS ONE 14(7): e0219061 
  • Flannagan KS, et al. 2020. Is opioid use safe in women trying to conceive? Epidemiology. 31(6): 844–851. 
  • Fronczak CM, et al. 2012. The insults of illicit drug use on male fertility. Journal of andrology. 33(4): 515-528. 
  • Interrante JD, et al. 2021. Prescription opioid use during pregnancy and risk for preterm birth or term low birthweight. Journal of opioid management 17(3):215-225. 
  • Ito S. 2018. Opioids in breast milk: Pharmacokinetic principles and clinical implications. The Journal of Clinical Pharmacology, 58: S151-S163. 
  • Juurlink DN, et al. 2012. Postpartum maternal codeine therapy and the risk of adverse neonatal outcomes: a retrospective cohort study. Clinical Toxicol. 50:5.  
  • Kallen B,  Reis M. 2015. Use of tramadol in early pregnancy and congenital malformation risk. Reprod Toxicol. 58:246-251. 
  • Kelly LE, et al. 2013. A clinical tool for reducing central nervous system depression among neonates exposed to codeine through breast milk. PLoS ONE. 8(7):370073. 
  • Khan K,  Chang J. 1997. Neonatal abstinence syndrome due to codeine. Arch Dis Child. 76:F59-F60.  
  • Konijnenberg C, el at. 2022. Verbal and nonverbal memory in school-aged children born to opioid-dependent mothers. Early human development, 171, 105614. 
  • Lazaryan M,  et al. 2015. Codeine should not be prescribed for breastfeeding mothers or children under the age of 12. Acta paediatrica 104(,6): 550-556. 
  • Lind JN, et al. 2017. Maternal use of opioids during pregnancy and congenital malformations. A Systematic Review. Pediatrics. 139(6):e20164131.  
  • Mactier H, et al. 2020. Prenatal opioid exposure – Increasing evidence of harm. Early human development, 150, 105188. 
  • Mangurten HH. 1980. Neonatal codeine withdrawal in infants of non-addicted mothers. Pediatrics. 65:159-160. 
  • Meny RG, et al. 1993. Codeine and the breastfed neonate. Journal of human lactation  9(4): 237-240. 
  • Nair V, et al. 2012. Neonatal withdrawal syndrome due to maternal codeine use. Paediatr Child Health. 17(5):e40-e41. 
  • Nezvalová-Henriksen K, et al. 2011. Effects of codeine on pregnancy outcomes from a large population-based cohort study. Eur J Clin Pharmacol. 67:1253-1261. 
  • Rothman KJ, et al. 1979. Exogenous hormones and other drug exposures of children with congenital heart disease. Am J Epidemiol. 109(4):433-439. 
  • Rubenstein E, et al. 2019. Brief Report: Maternal opioid prescription from preconception through pregnancy and the odds of autism spectrum disorder and autism features in children. Journal of autism and developmental disorders, 49(1): 376–382. 
  • Saxén I. 1975. Associations between oral clefts and drugs taken during pregnancy. Int J Epidemiol. 4(1):37-44. 
  • Sachs, Hari Cheryl, and Committee On Drugs. 2013. The transfer of drugs and therapeutics into human breast milk: an update on selected topics. Pediatrics  132(3): e796-809. 
  • Shaw GM, et al. 1992. Congenital cardiac anomalies relative to selected maternal exposures and conditions during early pregnancy. Eur J Epidemiol. 8(5):757-760. 
  • Shaw GM, et al. 1998. Maternal illness, including fever and medication use as risk factors for neural tube defects. Teratology. 57(1):1-7. 
  • Semet M, et al. 2017. The impact of drugs on male fertility: a review. Andrology, 5(4), 640-663. 
  • Sujan AC, et al. 2019. Maternal prescribed opioid analgesic use during pregnancy and associations with adverse birth outcomes: A population-based study. PLoS Medicine. 16(12). 
  • U.S. Food and Drug Administration. 2017. Use of codeine and tramadol products in breastfeeding women – questions and answers. Available at https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/use-codeine-and-tramadol-products-breastfeeding-women-questions-and-answers. Accessed 2 June 2025.   
  • Van Leeuwen G, et al. 1965. Narcotic withdrawal reaction in a newborn infant due to codeine. Pediatrics. 36:635-636. 
  • Varney B, et al. 2024. Opioid analgesic exposure during the first trimester of pregnancy and the risk of major congenital malformations in infants: a systematic review and meta-analysis†. Anaesthesia. 79(9):967-977. 
  • Willmann, S, et al. 2009. Risk to the breast-fed neonate from codeine treatment to the mother: a quantitative mechanistic modeling study. Clin Pharmacol Ther. 86, 634–643. 
  • Yazdy MM, et al. 2013. Periconceptional use of opioids and the risk of neural tube defects. 2013. Obstet Gynecol. 122(4):838-844. 
  • Zierler S, Rothman KJ. 1985. Congenital heart disease in relation to maternal use of Bendectin and other drugs in early pregnancy. N Engl J Med. 313(6):347-352. 
  • Zipursky J, Juurlink DN. 2020. The implausibility of neonatal opioid toxicity from breastfeeding. Clin Pharmacol Ther. 108(5):964-970. 

 

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