Selected References:  

• Ceyhan ST, et al. 2010. Serum vitamin B12 and homocysteine levels in pregnant women with neural tube defect. Gynecol Endocrinol. 26(8):578-581.  
• Dror DK, Allen LH. 2018. Vitamin B-12 in human milk: A systematic review. Adv Nutr 9:358s-66s. 
• Duggan C, et al. 2014. Vitamin B-12 supplementation during pregnancy and early lactation increases maternal, breast milk, and infant measures of vitamin B-12 status. J Nutr. 144(5):758-764.  
• Groenen PMW, et al. 2004. Marginal maternal vitamin B12 status increases the risk of offspring with spina bifida. Am J Obstet Gynecol 191(1):11-17. 
• Hampel D, Allen LH. 2016. Analyzing B-vitamins in human milk: Methodological approaches. Crit Rev Food Sci Nutr 56:494-511. 
• Lai JS, et al. 2019. Maternal plasma vitamin B12 concentrations during pregnancy and infant cognitive outcomes at 2 years of age. Br J Nutr. 121(11):1303-1312.
• Munger RG, et al. 2021. Maternal vitamin B12 status and risk of cleft lip and cleft palate birth defects in Tamil Nadu State, India. Cleft Palate Craniofac J 58(5):567-576. 
• National Institute of Health Office of Dietary Supplements. 2024. Vitamin B12: Fact Sheet for Health Professionals. Available at: https://ods.od.nih.gov/factsheets/VitaminB12-HealthProfessional/. Accessed 6 Jun 2024.  
• Nelen WL, et al. 2000. Hyperhomocysteinemia and recurrent early pregnancy loss: a meta-analysis. Fertil Steril. 74(6):1196-1199. 
• Ray JG, Blom HJ. 2003. Vitamin B12 insufficiency and the risk of fetal neural tube defects. QJM. 96(4):289-295. 
• Ray JG, et al. 2007. Vitamin B12 and the risk of neural tube defects in a folic-acid-fortified population. Epidemiology 18(3):362-366. 
• Reznikoff-Etievant MF, et al. 2002. Low Vitamin B(12) level as a risk factor for very early recurrent abortion. Eur J Obstet Gynecol Reprod Biol. 104(2):156-159. 
• Senousy SM, et al. 2018. Association between biomarkers of vitamin B12 status and the risk of neural tube defects. J Obstet Gynaecol Res. 44(10):1902-1908.  
• Suarez L, et al. 2003. Maternal serum B12 levels and risk for neural tube defects in a Texas-Mexico border population. Ann Epidemiol 13(2):81-88.  
• Van Rooij IALM, et al. 2003. Vitamin and homocysteine status of mothers and infants and the risk of nonsyndromic orofacial clefts. Am J Obstet Gynecol 189(4):1155-1160.  
• Wilson A, et al. 1999. A common variant in methionine synthase reductase combined with low cobalamin (vitamin B12) increases risk for spina bifida. Mol Genet Metab. 67(4):317-323. 
• Zhang T, et al. 2009. Maternal serum vitamin B12, folate and homocysteine and the risk of neural tube defects in the offspring in a high-risk area of China. Public Health Nutr. 12(5):680-686.  

Selected References:

• Aleck KA & Bartley DL. 1997. Multiple malformation syndrome following fluconazole use in pregnancy: report of an additional patient. Am J Med Genet 72:253-6.  
• Alsaad AM, et al. 2015. Exposure to fluconazole and risk of congenital malformations in the offspring: a systematic review and meta-analysis. Reprod Toxicol 52: 78-82. 
• Bérard A, et al. 2019. Associations between low- and high-dose oral fluconazole and pregnancy outcomes: 3 nested case-control studies. CMA J 2019;191: E179-E187. 
• Budani, M. C., et al. 2021.. Maternal use of fluconazole and congenital malformations in the progeny: A meta-analysis of the literature. Reproductive toxicology, 100:42–51.  
• Diflucan® Drug Label. 2024. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019949s072lbl.pdf. [Accessed 8/2025]. 
• Carey JC, et al. 2009. Determination of human teratogenicity by the astute clinician method: review of illustrative agents and a proposal of guidelines. Birth Defects Res A Clin Mol Teratol. 85(1):63-8.  
• Centers for Disease Control and Prevention (CDC). 2021. Vulvovaginal Candidiasis (VVC) STI Treatment Guidelines. Available at: https://www.cdc.gov/std/treatment-guidelines/candidiasis.htm 
• el-Medany AH, Hagar HH. 2002. Effect of fluconazole on fertility of male rabbits. Arzneimittelforschung. 52:636-40.  
• Force RW. 1995. Fluconazole concentrations in breast milk. Pediatr Infect Dis J. 14:235-6. 
• Howley MM, et al, the National Birth Defects Prevention Study. 2016. Fluconazole use and birth defects in the National Birth Defects Prevention Study. Am J Obstet Gynecol 214:657.e1-9. 
• Inman W, et al. 1994. Safety of fluconazole in the treatment of vaginal candidiasis. A prescription-event monitoring study, with special reference to the outcome of pregnancy. Eur J Clin Pharmacol 46:115-8.  
• Jick SS. 1999. Pregnancy outcomes after maternal exposure to fluconazole. Pharmacotherapy 19:221-2.  
• Kaplan YC, et al. 2015. Fluconazole use during breastfeeding. Can Fam Phys. 61:875-6. 
• Latour M, et al. 2024. Risk of congenital malformations and miscarriages following maternal use of oral fluconazole during the first trimester of pregnancy: a systematic review and meta-analysis. Eur J Epidemiol. 39(12):1325-1340. 
• Lee BE, et al. 1992. Congenital malformations in an infant born to a woman treated with fluconazole. Pediatr Infect Dis J 11:1062-4.  
• Liu D, et al. 2020. Fetal outcomes after maternal exposure to oral antifungal agents during pregnancy: A systematic review and meta-analysis. Int J Gynaecol Obstet 148(1): 6-13.  
• Lopez-Rangel E & Van Allen MI. 2005. Prenatal exposure to fluconazole: an identifiable dysmorphic phenotype. Birth Defects Res A Clin Mol Teratol 73:919-23.  
• Mastroiacovo P, et al. 1996. Prospective assessment of pregnancy outcomes after first-trimester exposure to fluconazole. Am J Obstet Gynecol 175:1645-50.  
• Mølgaard-Nielsen D, et al. 2013. Use of oral fluconazole during pregnancy and the risk of birth defects. N Engl J Med 369:830-9.  
• Mølgaard-Nielsen D, et al. 2016. Association between use of oral fluconazole during pregnancy and risk of spontaneous abortion and still birth. JAMA 315(1):58-67. 
• Moorhead AM, et al. 2011. A prospective study of fluconazole treatment for breast and nipple thrush. Breastfeed Rev 19:25-9. 
• Nørgaard M, et al. 2008. Maternal use of fluconazole and risk of congenital malformations: a Danish population-based cohort study. J Antimicrob Chemother 62:172-6.  
• Pasternak B, et al. 2018. Oral fluconazole in pregnancy and risk of stillbirth and neonatal death. JAMA. 319(22):2333-2335. 
• Pursley TJ, et al. 1996. Fluconazole-induced congenital anomalies in three infants. Clin Infect Dis 22:336-40.  
• Sorensen HT, et al. 1999. Risk of malformations and other outcomes in children exposed to fluconazole in utero. Br J Clin Pharmacol. 48(2):234-8.  
• US Food and Drug Administration (FDA). 2019. FDA Drug Safety Communication: FDA to review study examining use of oral fluconazole (Diflucan) in pregnancy. https://www.fda.gov/Drugs/DrugSafety/ucm497482.htm.  
• Zhang Z, et al. 2019.The safety of oral fluconazole during the first trimester of pregnancy: a systematic review and meta-analysis. BJOG. Aug 24. doi: 10.1111/1471-0528.15913. 
• Zhu Y, et al. 2020. Oral fluconazole use in the first trimester and risk of congenital malformations: population-based cohort study. BMJ 369: m1494. 

Selected References:  

• Asadi L, Bunce PE. 2013. West Nile virus infection. CMAJ;185(18):E846. 
• Centers for Disease Control and Prevention. 2004. Interim Guidelines for the Evaluation of Infants Born to Mothers Infected with West Nile Virus During Pregnancy. MMWR 53(07):154-156. 
• Centers for Disease Control and Prevention. 2002. Intrauterine West Nile Virus Infection – New York, 2002. MMWR 51(50):1135-1136. 
• Centers for Disease Control and Prevention. 2002. Possible West Nile Virus Transmission to an Infant Through Breastfeeding – Michigan, 2002. MMWR 51(39):877-878. 
• Centers for Disease Control and Prevention. 2021. West Nile Virus Transmission. https://www.cdc.gov/west-nile-virus/php/transmission//  
• Centers for Disease Control and Prevention. 2022. West Nile Virus Symptoms, Diagnosis, & Treatment. https://www.cdc.gov/westnile/symptoms/index.html.  
• Committee on Infectious Disease, American Academy of Pediatrics: 2021 Red Book: Report of the Committee on Infectious Diseases, 32nd Edition, page 848. 
• Herring R, et al. 2019. Pediatric West Nile Virus-Associated Neuroinvasive Disease: A Review of the Literature. Pediatr Neurol 92(March):16-25. 
• Hinckley AF, et al. 2006. West Nile Virus Infection Among Pregnant Women in A Northern Colorado Community, 2003-2004. Am J Epidemio 163(11Suppl): S55. 
• Hinckley AF, et al. 2007. Transmission of West Nile virus through human breast milk seems to be rare. Pediatrics 119(3):e666-671. 
• Mann TZ et al. 2018. Breast milk transmission of flaviviruses in the context of Zika virus: A systematic review. Paediatr Perinat Epidemiol 32(4):358-368. 
• O’Leary DR, et al. 2006. Birth outcomes following West Nile Virus infection of pregnant women in the United States: 2003-2004. Pediatrics 117(3):e537-545 
• Paisley JE, et al. 2006. West Nile virus infection among pregnant women in a northern Colorado community, 2003 to 2004. Pediatrics 117(3):814-820. 
• Pridjian, et al. 2016. Prospective Study of Pregnancy and Newborn Outcomes in Mothers with West Nile Illness during Pregnancy. Birth Defects Res A Clin Mol Teratol 106(8):716-723. 
• Rasmussen SA, et al. 2017. Studying the Effects of Emerging Infections on the Fetus:  Experience with West Nile and Zika Viruses. Birth Defects Res 109(5):363-371. 
• Sirois et, al. 2014. Developmental Outcomes in Young Children Born to Mothers with West Nile Illness during Pregnancy. Birth Defects Res A Clin Mol Teratol 100(10):792-796. 
• Stewart R, et al. 2013. West Nile Virus Infection in Pregnancy. Case Reports in Infectious Disease. V 2013, Article ID 351872. 
• Wesson DM. 2006. Is West Nile virus a teratogen? (abs) Birth Defects Research (Part A) 76:357. 

Selected References:

• Alwan S, et al. 2007. Use of selective serotonin-reuptake inhibitors in pregnancy and the risk of birth defects. N Engl J Med 356(26):2684-2692. 
• Ames JL, et al. 2021. Maternal psychiatric conditions, treatment with selective serotonin reuptake inhibitors, and neurodevelopmental disorders. Biol Psychiatry. 90(4):253-262. 
• Andersen JT, et al. 2014. Exposure to selective serotonin reuptake inhibitors in early pregnancy and the risk of miscarriage. Obstet Gynecol. 124(4):655-661. 
• Anderson KN, et al. 2020. Maternal use of specific antidepressant medications during early pregnancy and the risk of selected birth defects. JAMA Psychiatry. 77(12):1246-1255. 
• Andrade S, et al. 2009. Antidepressant use and risk of persistent pulmonary hypertension of the newborn. Pharmacoepidemiol Drug Saf 18(3):246-252. 
• Aynaoglu, Y., et al. 2021. Effect of diazepam, sertraline, and melatonin on the stress-induced reproductive in female rats. J Matern Fetal Neonatal Med. 34(24): 4103-4109. 
• Berard A, et al. 2017. Antidepressant use during pregnancy and the risk of major congenital malformations in a cohort of depressed pregnant women: An updated analysis of the Quebec Pregnancy Cohort. BMJ Open;7: e013372. 
• Bonari L, et al. 2004. Perinatal risks of untreated depression during pregnancy. Can J Psychiatry 49(11):726-735. 
• Cantin C, et al. 2024. Neonates With In-Utero SSRI Exposure (NeoWISE): A retrospective cohort study examining the effect of newborn feeding method on newborn withdrawal. Int J Popul Data Sci 9:2458. 
• Casper R, et al. 2003. Follow-up of children of depressed mothers exposed or not exposed to antidepressant drugs during pregnancy. J Pediatr 142:402- 408. 
• Chambers C, et al. 2006. Selective serotonin-reuptake inhibitors and risk of persistent pulmonary hypertension of the newborn. N Engl J Med 354(6)579- 587. 
• Cuomo A, et al. 2018. Using sertraline in postpartum and breastfeeding: balancing risks and benefits. Expert Opin Drug Saf. 17(7):719-725. 
• Den Besten-Bertholee D, et al. 2024. Sertraline, citalopram and paroxetine in lactation: passage into breastmilk and infant exposure. Front Pharmacol. 15:1414677. 
• Desaunay P, et al. 2023. Benefits and Risks of Antidepressant Drugs During Pregnancy: A Systematic Review of Meta-analyses. Paediatric drugs. 25(3): 247-265. 
• De Vries C, et al. 2021. A systematic review and meta-analysis considering the risk for congenital heart defects of antidepressant classes and individual antidepressants. Drug Safety 44(3):291–312.  
• Ericson A, et al. 1999. Delivery outcome after the use of antidepressants in early pregnancy. Eur J Clin Pharmacol 55:503-508. 
• Furu K, et al. 2015. Selective serotonin reuptake inhibitors and venlafaxine in early pregnancy and risk of birth defects: population based cohort study and sibling design. BMJ. 350:h1798. 
• Galbally, M., et al. 2023. Fetal SSRI antidepressant exposure and infant sleep: Findings from the MPEWS pregnancy cohort study. Infant Behav Dev. 72:101849. 
• Grigoriadis S, et al. 2013. The effect of prenatal antidepressant exposure on neonatal adaptation: a systematic review and meta-analysis. J Clin Psychiatry. 74(4):e309-20. 
• Grigoriadis et al. 2014. Prenatal exposure to antidepressants and persistent pulmonary hypertension of the newborn: systematic review and meta-analysis. BMJ 348:f6932 
• Heinonen E, et al. 2021. Sertraline concentrations in pregnant women are steady and the drug transfer to their infants is low. Eur J Clin Pharmacol. 77(9):1323-1331. 
• Hendrick V, et al. 2001. Use of sertraline, paroxetine and fluvoxamine by nursing women. Br J Psychiatry. 179:163-166. 
• Hogue AN, et al. 2017. Effects of in-utero exposure to selective serotonin reuptake inhibitors and venlafaxine on term and preterm infants. J Neonatal Perinatal Med. 10(4):371-380. 
• Jordan S, et al. 2016. Selective serotonin reuptake inhibitor (SSRI) in pregnancy and congenital anomalies: Analysis of linked databases in Wales, Norway and Funen, Denmark. PLoS One. 11(12):e0165122. 
• Källén B, Olausson PO. 2008. Maternal use of selective serotonin re-uptake inhibitors and persistent pulmonary hypertension of the newborn. Pharmacoepidemiol Drug Saf. (8):801-806. 
• Kallen BAJ, et al. 2007. Maternal use of selective serotonin re-uptake inhibitors in early pregnancy and infant congenital malformations. Birth Defects Res A Clin Mol Teratol 79(4):301-308. 
• Kieler H, et al. 2011. Selective serotonin reuptake inhibitors during pregnancy and risk of persistent pulmonary hypertension in the newborn: a population based cohort study from five Nordic countries. BMJ 344:d8012. 
• Kieviet N, et al. 2015. Risk factors for poor neonatal adaptation after exposure to antidepressants in utero. Acta Paediatr. 104(4):384-91. 
• Kolding L et al. 2019. Sertraline use during pregnancy and effect on fetal cardiac function. J Maternal Fetal Neonatal Med. 12:1-8. 
• Kristensen JH, et al. 1998. Distribution and excretion of sertraline and N-desmethylsertraline in human milk. Br J Clin Pharmacol 45:453-457. 
• Levinson-Castiel R, et al. 2006. Neonatal abstinence syndrome after in utero exposure to selective serotonin reuptake inhibitors in term infants. Arch Pediatr Adolesc Med 160:173-176.  
• Leutritz AL, et al. 2023. Psychotropic medication in pregnancy and lactation and early development of exposed children. Br J Clin Pharmacol. 89(2):737-750. 
• Louik C, et al. 2007 First trimester use of selective serotonin-reuptake inhibitors and the risk of birth defects. N Engl J Med 356(26):2675-2683. 
• Mammen OK, et al. 1997. Sertraline and norsertraline levels in three breastfed infants. J Clin Psychiatry 58:100-103. 
• Marks C, eral. 2021. Comparing newborn outcomes after prenatal exposure to individual antidepressants: A retrospective cohort study. Pharmacotherapy. 41(11):907-914. 
• Masarwa R, et al. 2019. Prenatal exposure to selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors and risk for persistent pulmonary hypertension of the newborn: a systematic review, meta-analysis, and network meta-analysis. Am J Obstet Gynecol. 220(1):57. 
• Mattson S, et al. 1999. Neurobehavioral follow-up of children prenatally exposed to fluoxetine [abstract]. In: Teratology 59:376. 
• Misiri S, et al. 2006. Internalizing behaviors in 4-year-old children exposed in utero to psychotropic medications. American Journal of Psychiatry. 163(6): 1026-1032. 
• Nulman I, et al. 1997. Neurodevelopment of children exposed in utero to antidepressant drugs. N Engl J Med 336 (4):258-262. 
• Oberlander TF, et al, 2008. Major congenital malformations following prenatal exposure to serotonin reuptake inhibitors and benzodiazepines using population based health data. Birth Defects Res B Dev Reprod Toxicol. 83(1):68 76. 
• Pedersen LH, et al. 2009. Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study. BMJ 339:b3569. 
• Pinheiro E, et al. 2015. Sertraline and breastfeeding: review and meta-analysis. Archives of Women’s Mental Health. 18(2):139-46. 
• Rommel A.-S.,et al. 2020. Long-term effects of intrauterine exposure to antidepressants on physical, neurodevelopmental, and psychiatric outcomes: A systematic review. J Clin Psychiatry 81(3): 19r12965.  
• Sanz E, et al. 2005. Selective serotonin reuptake inhibitors in pregnant women and neonatal withdrawal syndrome: a database analysis. Lancet 365:482-487. 
• Semet M, et al. 2017. The impact of drugs on male fertility: a review. Andrology 5(4): 640-663. 
• Sjaarda LA, et al. 2020. Urinary selective serotonin reuptake inhibitors across critical windows of pregnancy establishment: A prospective cohort study of fecundability and pregnancy loss. Fertility and Sterility, 114(6):1278–1287.  
• Stika C, et al. 2022. Changes in sertraline plasma concentrations across pregnancy and postpartum.  Clin Pharmacol Ther. 112(6):1280-1290. 
• Stowe ZN, et al. 1997. Sertraline and desmethylsertraline in human breast milk and nursing infants. Am J Psychiatry 154:1255-1260. 
• Suarez EA, et al. 2022. Association of antidepressant use during pregnancy with risk of neurodevelopmental disorders in children. JAMA Intern Med. 182(11):1149–60. 
• Sylvester C, et al. 2019. Selective serotonin reuptake inhibitors and fertility: Considerations for couples trying to conceive. Harv Rev Psychiatry 27(2):108-118. 
• Thomson, M, et al. 2021. Pharmacotherapeutic considerations for the treatment of posttraumatic stress disorder during and after pregnancy. Expert Opinion Pharmacother. 22(6):705-714. 
• Toh S, et al. 2009 Antidepressant use during pregnancy and the risk of preterm delivery and fetal growth restriction. J Clin Psychopharmacol. 29(6):555-60. 
• U.S. Food and Drug Administration. 2011 (current as of 2/13/2018). Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-selective-serotonin-reuptake-inhibitor-ssri-antidepressant-use-during#data. [Accessed 12/19]. 
• U.S. Food and Drug Administration. 2023. Zoloft® Drug Label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019839s108,20990s062lbl.pdf. [Accessed 8/2025]. 
• Wang S, et al. 2015. Selective serotonin reuptake inhibitors (ssris) and the risk of congenital heart defects: A meta-analysis of prospective cohort studies. J Am Heart Assoc 4(5):e001681. 
• Uguz, F. 2020. Selective serotonin reuptake inhibitors and the risk of congenital anomalies: A systematic review of current meta-analyses. Expert Opin Drug Saf 19(12):1595–1604.  
• Wisner KL, et al. 1998. Serum sertraline and N-desmethylsertraline levels in breastfeeding mother-infant pairs. Am J Psychiatry 155:690-692.  
• Womersely K, et al. 2017. What are the risks associated with different Selective Serotonin Re-uptake Inhibitors (SSRIs) to treat depression and anxiety in pregnancy? An evaluation of current evidence. Psychiatr Danub. 29(Suppl. 3):629-644. 
• Zheng L, et al. 2022. Antidepressants and antipsychotics in human pregnancy: Transfer across the placenta and opportunities for modeling studies. J Clin Pharmacol 62(Suppl. 1): S115-S128. 

Selected References:

• Bosworth, O. M., Padilla-Azain, M. C., Adgent, M. A., Spieker, A. J., Wiese, A. D., Pham, A., Leech, A. A., Grijalva, C. G., & Osmundson, S. S. (2024). Prescription Opioid Exposure During Pregnancy and Risk of Spontaneous Preterm Delivery. JAMA network open, 7(2), e2355990. https://doi.org/10.1001/jamanetworkopen.2023.55990 
• Brogly SB, Velez MP, Werler MM, Li W, Camden A, Guttmann A. Prenatal Opioid Analgesics and the Risk of Adverse Birth Outcomes. Epidemiology. 2021 May 1;32(3):448-456. doi: 10.1097/EDE.0000000000001328. PMID: 33625160; PMCID: PMC8011506. 
• Broussard CS, et al. 2011. Maternal treatment with opioid analgesics and risk for birth defects. American Journal of Obstetrics and     Gynecology, 204(4): 314.e1-314.e11. 
• Cobrinik RW et al. 1995. The effect of maternal narcotic addiction on the newborn infant. Pediatrics 24:288-304. 
• Collins LR, et al. 2005: Prolonged morphine exposure in utero causes fetal and placental vasoconstriction: a case report. J Matern Fetal Neonatal Med;17:417-21. 
• Daud AN, et al. 2015. P-glycoprotein-mediated drug interactions in pregnancy and changes in the risk of congenital anomalies: a case-reference study. Drug Safety, 38(7):651-659. 
• Feilberg FL, et al. Excretion of morphine in human breast milk. Acta Anaesthesiol Scand, 33(5):426-428. 
• Ghasemi-Esmailabad S, et al. 2022. The effects of morphine abuse on sperm parameters, chromatin integrity and apoptosis in men. JBRA Assist Reprod, 26(3):444-449.  
• Interrante JD, et al. 2017. Risk comparison for prenatal use of analgesics and selected birth defects, National Birth Defects Prevention Study 1997-2011. Annals of Epidemiology, 27(9):Epub ahead of print. 
• Ito, S. 2018. Opioids in breast milk: Pharmacokinetic principles and clinical implications. J Clin Pharmacol, 58 Suppl 10:S151-S163.  
• Larson, JJ, et al. 2019. Cognitive and behavioral impact on children exposed to opioids during pregnancy. Pediatrics, 142(2):e20190514.  
• Lind JN, et al. 2017. Maternal use of opioids during pregnancy and congenital malformations: A systematic review. Pediatrics, 139(6):e20164131. 
• Rothman KJ,, et al. 1979. Exogenous hormones and other drug exposures of children with congenital heart disease. American Journal of Epidemiology, 109(4):433-439. 
• Wang, Y., Berger, L., Durrance, C., Kirby, R. S., Kuo, D., Pac, J., & Ehrenthal, D. B. (2023). Duration and Timing of In Utero Opioid Exposure and Incidence of Neonatal Withdrawal Syndrome. Obstetrics and gynecology, 142(3), 603–611. https://doi.org/10.1097/AOG.0000000000005289