Fluoxetine (Prozac®)

Selected References:  

  • Alwan S, et al. 2016. Safety of selective serotonin reuptake inhibitors in pregnancy: a review of current evidence. CNS Drugs, 30(6):499-515.  
  • Andersen JT, et al. 2014. Exposure to selective serotonin reuptake inhibitors in early pregnancy and the risk of miscarriage. Obstet Gynecol, 124:655-661. 
  • Bandoli G, et al. 2020. Prenatal antidepressant use and risk of adverse neonatal outcomes. Pediatrics, 146(1):e20192493. 
  • 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.  
  • Burch KJ and Wells BG. 1992. Fluoxetine/norfluoxetine concentrations in human milk. Pediatrics, 89:676-677.  
  • Chambers CD, et al. 1999. Weight gain in infants breastfed by mothers who take fluoxetine. Pediatrics, 104(5):I1-15.  
  • 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.  
  • Desaunay P, Eude LG, Dreyfus M, Alexandre C, Fedrizzi S, Alexandre J, Uguz F, Guénolé F. Benefits and Risks of Antidepressant Drugs During Pregnancy: A Systematic Review of Meta-analyses. Paediatr Drugs. 2023 May;25(3):247-265. doi: 10.1007/s40272-023-00561-2. Epub 2023 Feb 28. PMID: 36853497. 
  • Diav-Citrin O, et al. 2008. Paroxetine and fluoxetine in pregnancy: a prospective, multicenter, controlled, observational study. Br J Clin Pharmacol, 66(5):695-705.  
  • Gao SY, et al. 2017. Fluoxetine and congenital malformations: a systematic review and meta-analysis of cohort studies. Br J Clin Pharmacol, 83(10):2134-2147.  
  • Goldstein DJ, Marvel DE. 1993. Psychotropic medications during pregnancy: risk to the fetus. JAMA, 270:2177. 
  • Goldstein DJ, et al. 1997. Effects of first-trimester fluoxetine exposure on the newborn. Obstet Gynecol, 89:713-8. 
  • 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 S, et al. 2019. Benzodiazepine use during pregnancy alone or in combination with an antidepressant and congenital malformations: systematic review and meta-analysis. J Clin Psychiatry, 80(4):18r12412.  
  • Huybrechts KF, et al. 2014. Antidepressant use in pregnancy and the risk of cardiac defects. N Engl J Med, 370:2397-2407. 
  • Huybrechts KF, et al. 2015. Antidepressant use late in pregnancy and risk of persistent pulmonary hypertension of the newborn. JAMA, 313(21):2142-2151. 
  • Isenberg KE. 1990. Excretion of fluoxetine in human breast milk. J Clin Psychiatry, 51:169.  
  • Jimenez-Solem E et al. 2012. Exposure to selective serotonin reuptake inhibitors and the risk of congenital malformations: a nationwide cohort study. BMJ, 2:e001148. 
  • Jordan S, et al. 2019. Antidepressant prescriptions, discontinuation, depression, and perinatal outcomes, including breastfeeding: a population cohort analysis. PLoS One, 14(11):e0225133. 
  • Kaplan et al. 2017. Maternal SSRI discontinuation, use, psychiatric disorder and the risk of autism in children: a meta-analysis of cohort studies. Br J Clin Pharmacol, 83(12):2798-2806. 
  • Kieviet N, et al. 2015. Risk factors for poor neonatal adaptation after exposure to antidepressants in utero. Acta Paediatr, 104(4):384-391.  
  • Kristensen JH, et al. 1999. Distribution and excretion of fluoxetine and norfluoxetine in human milk. Br J Clin Pharmacol, 48(4):521-527.  
  • 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.  
  • Louik C, et al, 2007. First-trimester use of selective serotonin-reuptake inhibitors and the risk of birth defects. N Engl J Med, 356:2675-2683.  
  • Lusskin SI, et al. 2018. Pharmacotherapy for Perinatal Depression. Clin Obstet Gynecol, 61(3):544-561.  
  • Masarwa R, et al. 2019. Prenatal exposure to selective serotonin 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.e1-57.e13. 
  • Morris R, Matthes J. 2015. Serotonin syndrome in a breast-fed neonate. BMJ Case Rep, doi:10.1136/bcr-2015-209418. 
  • Moses-Kolko, E.L. et al. 2005. Neonatal signs after late in utero exposure to serotonin reuptake inhibitors. Literature review and implications for clinical applications. J Am Med Assoc, 293: 2372-2383.  
  • Nulman I, et al. 1997. Neurodevelopment of children exposed in utero to antidepressant drugs. NEJM, 336(4):258-262.  
  • Nulman I, et al. 2002. Child development following exposure to tricyclic antidepressants or fluoxetine throughout fetal life: a prospective, controlled study. Am J Psychiatry, 159(11):1889-1895. 
  • Ornoy A. 2017. Neurobehavioral risks of SSRIs in pregnancy: Comparing human and animal data. Reprod Toxicol, 72:191-200. 
  • PD-Rx Pharmaceuticals, Inc. 2025. Fluoxetine capsules: Prescribing information. DailyMed. [Accessed August 2026]. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d26f7450-7650-43df-a63b-1fe2472882a9&type=display 
  • Pedersen LH, et al. 2009. Selective serotonin inhibitors in pregnancy and congenital malformations: population based cohort study. BMJ, 339:b3569.  
  • Rampono J, et al. 2009. Placental transfer of SSRI and SNRI antidepressants and effects on the neonate. Pharmacopsychiatry, 42(3):95-100. 
  • Ruchkin V, Martin A. 2005. SSRIs and the developing brain. Lancet, 365:451-453. 
  • Sanz E, et al. 2005. Selective serotonin reuptake inhibitors in pregnant women and neonatal withdrawal syndrome: a database analysis. Lancet, 365:482-487.  
  • Sjaarda LS et al. 2020. Urinary selective serotonin reuptake inhibitors across critical windows of pregnancy establishment: a prospective cohort study of fecundability and pregnancy loss. Fertil Steril, 114(6):1278-1287. 
  • Strain, SL. 1994. Fluoxetine-initiated ovulatory cycles in two clomiphene-resistant women. J Am J Psychiatry, 151(4):620.  
  • Salisbury AL, et al. 2016. The roles of maternal depression, serotonin reuptake inhibitor treatment, and concomitant benzodiazepine use on infant neurobehavioral functioning over the first postnatal month. Am J Psychiatry, 173(2):147-157. 
  • Sylvester C, et al. 2019. selective serotonin reuptake inhibitors and fertility: considerations for couples trying to conceive. Harv Rev Psychiatry, 27(2):108-118. 
  • Taddio A, Ito S, and Koren G. 1996. Excretion of fluoxetine and its metabolite, norfluoxetine, in human breastmilk. J Clin Pharmacol, 36(1)42-47.  
  • Vaidya R, et al. 2024. Non epileptiform abnormal neurologic signs in newborns following in-utero psychotropic medication exposure. Journal of Neonatal-Perinatal Medicine. 17(5):717-722.  
  • Wang S, et al. 2015. Selective serotonin reuptake inhibitors (SSRIs) and the risk of congenital heart defects: a meta-analysis of prospective cohort studies. Journal of the American Heart Association, 4(5)e001681. 
  • Wen SW, et al. 2006. Selective serotonin reuptake inhibitors and adverse pregnancy outcomes. Am J Obstet Gynecol, 194(4):961-966.  
  • Wisner KL, Avram MJ, George AL Jr, Abramova TV, Yang A, Caritis SN, Costantine MM, Stika CS. Concentrations of Fluoxetine Enantiomers Decline During Pregnancy and Increase After Birth. J Clin Psychopharmacol. 2024 Mar-Apr 01;44(2):100-106. 
  • Yang F, et al. 2017. Risk of autism spectrum disorder in offspring following paternal use of selective serotonin reuptake inhibitors before conception: a population-based cohort study. BMJ Open, 7(12):e016368. 
  • Yang F, et al. 2018. Prenatal paternal selective serotonin reuptake inhibitors use and risk of ADHD in offspring. Pediatrics, 141(1):e20171081.  
  • Yonkers KA, et al. 2009. The management of depression during pregnancy: a report from the American Psychiatric Association and the American College of Obstetricians and Gynecologists. Obstet Gynecol, 114(3):703-713. 
  • Yoshida, K, et al. 1998. Fluoxetine in breastmilk and developmental outcome of breastfed infants. Br J Psychiatry, 172:175-178. Pregnant Women with Suspected or Confirmed Influenza. Obstet Gyn, 132(4):e169-e173. 


Fluoxetine (Prozac®)

Selected References:

  • Akbari M, et al. 2013. Systematic review and meta-analysis on the effects of thiopurines on birth outcomes from female and male patients with inflammatory bowel disease. Inflamm Bowel Dis, 19(1):15-22.
  • Alami Z, et al. 2018. Pregnancy outcome following in utero exposure to azathioprine: a French comparative observational study. Therapie, 73(3):199-207.
  • Alshwairikh LA, Zeneb B. 2022. A 25-year-old Saudi woman with a 2-year history of antisynthetase syndrome with interstitial lung disease who commenced azathioprine treatment in the third trimester of pregnancy and had a successful birth at term. Am J Case Rep, 7:23:e936833.
  • Balevic S, et al. 2024. Azathioprine metabolite levels and outcomes during pregnancies with rheumatic disease. Lupus Sci Med, 11(1):e0011036.
  • Casanova MJ, et al. 2013. Safety of thiopurines and anti-TNF-alpha drugs during pregnancy in patients with inflammatory bowel disease. Am J Gastroenterol, 108(3):433-440.
  • Christensen LA, et al. 2008. Azathioprine treatment during lactation. Aliment Pharmacol Ther, 28(10):1209-1213.
  • Davison JM et al. 1985. Maternal azathioprine therapy and depressed haematopoiesis in the babies of renal allograft patients. Br J Obstet Gynaecol, 92:233-239.
  • de Meij TG, et al. 2013. Dutch Initiative on crohn and colitis. Long-term follow-up of children exposed intrauterine to maternal thiopurine therapy during pregnancy in females with inflammatory bowel disease. Aliment Pharmacol Ther, 38(1):38-43.
  • Dejaco C, et al. 2001. Azathioprine treatment and male fertility in inflammatory bowel disease. Gastroenterology, 121:1048-53.
  • Francella A, et al. 2003. The safety of 6-mercaptopurine for childbearing patients with inflammatory bowel disease: a retrospective cohort study. Gastroenterology, 124(1):9-17.
  • Friedman S, et al. 2017. Paternal use of azathioprine/6-mercaptopurine or methotrexate within 3 months before conception and long-term health outcomes in the offspring: a nationwide cohort study. Reproductive Toxicology, 73:196-200.
  • Götestam Skorpen C, et al. 2016. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis, 75(5):795-810.
  • Goldstein LH, et al. 2007. Pregnancy outcome of women exposed to azathioprine during pregnancy. Birth Defects Res A Clin Mol Teratol, 79(10):696-701.
  • Hoeltzenbein M, et al. 2012. Pregnancy outcome after paternal exposure to azathioprine/6-mercaptopurine. Reprod Toxicol, 34(3):364-369.
  • Ikram N, at al. 2021. Breastfeeding in women with rheumatic diseases. Lupus Sci Med, 8(1):e000491.
  • Khedr L, Ekram M. 2024. Eur J Case Rep Intern Med, 11(4):004385.
  • Kinnucan J, Kane S. 2021. Editorial: thiopurines but not anti-TNF monotherapy are linked to worse pregnancy outcomes in a large population-based study. Aliment Pharmacol Ther, 54(3):343-344.
  • Langagergaard V, et al. 2007. Birth outcome in women treated with azathioprine or mercaptopurine during pregnancy: a Danish nationwide cohort study. Aliment Pharmacol Ther, 25(1):73-81.
  • Matalon ST, et al. 2004. Review of the potential effects of three commonly used antineoplastic and immunosuppressive drugs (cyclophosphamide, azathioprine, doxorubicin on the embryo and placenta). Reprod Toxicol, 18(2):219-230.
  • Matarazzo L, et al. 2021. Pregnancy outcome in women with childhood onset autoimmune hepatitis and autoimmune sclerosing cholangitis on long-term immunosuppressive treatment. Eur J Obstet Gynecol Reprod Biol, 268:7-11.
  • Moretti ME et al. 2006. Breast-feeding during maternal use of azathioprine. Ann Pharmacother, 40(12):2269-2272.
  • Motta M, et al. 2007. Immune system development in infants born to mothers with autoimmune disease, exposed in utero to immunosuppressive agents. Am J Perinatol, 24(8):441-447.
  • Myer A, et al. 2021. Comparative study of pregnancy outcomes in women with inflammatory bowel disease treated with thiopurines and/or anti-TNF: a French nationwide study 2010-2018. Aliment Pharmacol Ther, 54(3):302-311.
  • Nørgård B, et al. 2004. The risk of congenital abnormalities in children fathered by men treated with azathioprine or mercaptopurine before conception. Aliment Pharmacol Ther, 19(6):679-685.
  • Reynolds JA, et al. 2023. Outcomes of children born to mothers with systemic lupus erythematosus exposed to hydroxychloroquine or azathioprine. Rheumatology (Oxford), 62(3):1124-1135.
  • Skejo C, et al. 2024. Early onset sepsis and lobar pneumonia in a newborn exposed in utero to Ustekinumab and azathioprine. Inflamm Bowel Dis, 30(2):314-315.
  • Wolf MF, et al. 2023. Azathioprine and 6-mercaptopurine-induced intrahepatic cholestasis of pregnancy: case report and review of literature: Taiwan J Obstet Gynecol, 63(5):761-764.


Fluoxetine (Prozac®)

Selected References:  

  • Adank MC, et al. 2019. Is maternal lipid profile in early pregnancy associated with pregnancy complications and blood pressure in pregnancy and long term postpartum?.Obstet Gynecol; 221(2): 150-e1. 
  • Agarwala A, et al. 2024. Dyslipidemia management in women of reproductive potential: An Expert Clinical Consensus from the National Lipid Association. J Clin Lipidol; 18(5):e664-e684. 
  • Arias A, et al. 2022. Implications of High-Density Cholesterol Metabolism for Oocyte Biology and Female Fertility. Frontiers in cell and developmental biology; 10:941539.  
  • Berge LN, et al. 1996. Pregnancy related changes in some cardiovascular risk factors. Acta Obstet Gynecol Scand; 75:439–442. 
  • Brizzi P, et al. 1999. Lipoprotein metabolism during normal pregnancy. Obstet Gynecol;  181(2):430-34. 
  • Christensen S, et al. 2023. Maternal inflammatory, lipid and metabolic markers and associations with birth and breastfeeding outcomes. Frontiers in nutrition; 10:1223753.  
  • Christopher BA, et al. 2019. Evaluation and management of lipid disorders: summary. Clinical Updates in Women’s Health Care. American College of Obstetricians and Gynecologists. Obstet Gynecol;  133:609. 
  • Cristodoro M, et al. 2024. Dietary Patterns and Fertility. Biology; 13(2),131.  
  • Dal Pino B, et al. 2026. Severe familial hypercholesterolemia and pregnancy: handle with care. Nutr Metab Cardiovasc Dis; 104767.  
  • de Oliveira AA, et al. 2026. Excessive hypercholesterolaemia during pregnancy as a risk factor for endothelial dysfunction in pre-eclampsia. J Physiol; 604(11):4302-4317.  
  • France M, et al. 2016. HEART UK statement on the management of homozygous familial hypercholesterolaemia in the United Kingdom. Atherosclerosis; 255:128-139.  
  • Graham DF, et al. 2021. Management of familial hypercholesterolemia in pregnancy. Curr Opin Lipidol; 32(6):370-377. 
  • Goharkhay N, et al. 2008. Maternal hypercholesterolemia leads to activation of endogenous cholesterol synthesis in the offspring. Amer J Obstet Gynecol; 199(3): 273-e1. 
  • Goldberg AC et al. 2011. Familial hypercholesterolemia: screening, diagnosis and management of pediatric and adult patients: clinical guidance from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Clin Lipidol; 5(3 Suppl):S1-8.  
  • Gootjes D, et al. 2022. Maternal lipid profile in pregnancy and embryonic size: a population-based prospective cohort study. BMC pregnancy and childbirth; 22(1):333.  
  • Grandi SM, et al. 2026. Elevated lipid levels and altered semen parameters in men of couples seeking fertility care. Am J Epidemiol; May 12:kwag103. 
  • Holven KB, et al. 2026. Challenges in the care of women with familial hypercholesterolaemia during the reproductive period – current evidence and practical guidance. Atherosclerosis; 415:120679. 
  • Jiang S et al. 2017. Maternal dyslipidemia during pregnancy may increase the risk of preterm birth: A meta-analysis. Taiwan J Obstet Gynecol; 56(1):9-15.  
  • Kaneko K, et al. 2022. High Maternal Total Cholesterol Is Associated With No-Catch-up Growth in Full-Term SGA Infants: The Japan Environment and Children’s Study. Frontiers in endocrinology; 13:939366.  
  • Klevmoen M, et al. 2021. Loss of statin treatment years during pregnancy and breastfeeding periods in women with familial hypercholesterolemia. Atherosclerosis;. 335:8-15.  
  • Liberis A, et al. 2021. Lipid Disorders in Pregnancy. Curr Pharm Des. 27(36):3804-3807. 
  • Mauri M, et al. 2021. Dyslipemias and pregnancy, an update. Clin Investig Arterioscler. 33(1):41-52.  
  • Moayeri M, et al. 2017. Maternal lipid profile and the relation with spontaneous preterm delivery: a systematic review. Arch Gynecol Obstet; 295(2):313-323. 
  • Mulder J, et al. 2024. Lipid metabolism during pregnancy: consequences for mother and child. Current opinion in lipidology; 35(3): 133-140.  
  • Napoli C, et al. 1999. Influence of maternal hypercholesterolaemia during pregnancy on progression of early atherosclerotic lesions in childhood: Fate of Early Lesions in Children (FELIC) study. Lancet; 354(9186): 1234-41.  
  • Nasioudis D, et al. 2018. Dyslipidemia in pregnancy and maternal-fetal outcome. Minerva ginecologica. 71(2):155-62. 
  • Ogura et al. 2016. Lipoprotein apheresis is essential for managing pregnancies in patients with homozygous familial hypercholesterolemia: Seven case series and discussion. Atherosclerosis; 254:179-183. 
  • Omolaoye T, et al. 2022. Statins and Male Fertility: Is There a Cause for Concern?. Toxics; 10(10):627.  
  • Pugh et al. 2017. Preconception maternal lipoprotein levels in relation to fecundability. Hum Reprod.15:1-9. 
  • Pushpendra A, et al. 2015. Hyper-lipidemia and male fertility: a critical review of literature.  Andrology; 4(2).  
  • Schisterman EF, et al. 2014. Lipid concentrations and couple fecundity: the LIFE study. J Clin Endocrinol Metab; 99(8):2786-94. 
  • Schisterman EF, et al. 2014. Lipid concentrations and semen quality: the LIFE study. Andrology; 2(3):408-15. 
  • Sharami SH, 2019. The relationship of hyperlipidemia with maternal and neonatal outcomes in pregnancy: A cross-sectional study. International Journal of Reproductive BioMedicine; 17(10): 739. 
  • Smith CJ, et al. 2018. Maternal dyslipidemia and risk for preterm birth. PloS one; 13(12): e0209579. 
  • Toleikyte I, et al. 2011. Pregnancy outcomes in familial hypercholesterolemia: a registry-based study. Circulation; 124(15):1606-14. 
  • Varnier NA, et al. 2015. Coronary artery disease secondary to familial hypercholesterolaemia: An infrequent cause of increasingly common pregnancy co-morbidity. Obstet Med; 8(3):152-4. 
  • Vrijkotte TG, et al. 2012. Maternal lipid profile during early pregnancy and pregnancy complications and outcomes: the ABCD study. The Journal of Clinical Endocrinology & Metabolism; 97(11): 3917-25. 
  • Wang C, et al. 2016. The associations between early pregnancy lipid profiles and pregnancy outcomes. J Perinatol.  37(2):127-133. 
  • Whitfield M, et al. 2015. Posttesticular sperm maturation, infertility, and hypercholesterolemia. Asian J Androl;  17(5):742-8. 
  • Wild R, et al. 2015. Dyslipidemia in pregnancy. Cardiology clinics; 33(2): 209-15. 
  • Wojcik-Baszko D, et al. 2018. Role of dyslipidemia in preeclampsia—A review of lipidomic analysis of blood, placenta, syncytiotrophoblast microvesicles and umbilical cord artery from women with preeclampsia. Prostaglandins & Other Lipid Mediators; 139: 19-23. 
  • Zhao X, et al. 2024. 27-Hydroxycholesterol inhibits trophoblast fusion during placenta development by activating PI3K/AKT/mTOR signaling pathway. Arch Toxicol; 98(3):849-863. 


Fluoxetine (Prozac®)

Selected References:

  • Breyer-Pfaff U, et al. 1995. Secretion of amitriptyline and metabolites into breast milk. The American Journal of Psychiatry; 152(5):812-813.  
  • Brixen-Rasmussen L, et al. 1982. Amitriptyline and nortriptyline excretion in human breast milk. Psychopharmacology; 76:94-95. 
  • Heinonen OP, et al. 1977. Birth Defect and Drugs in Pregnancy. Publishing Sciences Group Inc., Litteton, Mass. 
  • Huybrechts KF, et.al. 2014. Antidepressant use in pregnancy and the risk of cardiac defects. N Engl J Med; 370(25):2397-2407. 
  • Huybrechts KF, et al. 2015. Antidepressant use late in pregnancy and risk of persistent pulmonary hypertension of the newborn. JAMA; 313(21):2142-2151.  
  • Kronenfeld, N, et al. 2018. Chronic use of psychotropic medications in breastfeeding women: is it safe?. PloS One, 13(5): e0197196.  
  • Leutritz AL, et al. 2023. Psychotropic medication in pregnancy and lactation and early development of exposed children. British Journal of Clinical Pharmacology; 89(2):737-750.  
  • Lusskin SI, et al. 2018. Pharmacotherapy for perinatal depression. Clin Obstet Gynecol; 61(3):544-561. 
  • Marhofer D, et al. 2021. Schmerztherapie in der Schwangerschaft [Pain management during pregnancy: an expert-based interdisciplinary consensus recommendation.] Schmerz; 35:382–390. 
  • McElhatton PR, et al. 1996. The outcome of pregnancy in 689 women exposed to therapeutic doses of antidepressants. A collaborative study of the European Network of Teratology Information Service (ENTIS). Reprod Toxicol; 10:285-294. 
  • Misri S, Sivertz K. 1991. Tricyclic drugs in pregnancy and lactation: a preliminary report. Int J Psych Med; 21:157–171.  
  • Nulman I, et al. 1997. Neurodevelopment of children exposed in utero to antidepressant drugs. NEJM; 336(4):258-262. 
  • Nulman I, et al. 2002. Child development following exposure to tricyclic antidepressants or fluoxetine throughout fetal life: a prospective controlled study. Am J Psychiatry; 159(11):1889-1895. 
  • Palmsten K, et al. 2013. Antidepressant use and risk for preeclampsia. Epidemiology; 24(5):682-691. 
  • Phillips K, et al. 2026. Migraine, associated treatments and risk of miscarriage: a matched cohort study and nested case-control study using the CPRD pregnancy register. Cephalalgia; 46(1):3331024251414634.  
  • Sarayani A, et al. 2023. Real-world effect of a potential drug-drug interaction between topiramate and oral contraceptives on unintended pregnancy outcomes. Contraception; 120:109953.  
  • Schoretsanitis G, et al. 2021. Antidepressant transfer into amniotic fluid, umbilical cord blood & breast milk: a systematic review & combined analysis. Prog Neuropsychopharmacol Biol Psychiatry; 107:110228.  
  • Singh S, et al. 2024. Indian consensus on the role of amitriptyline in migraine prophylaxis. Cureus; 16(2):e54270.  
  • Suthar N, et al. 2018. Galactorrhea with antidepressants: a case series. Indian Journal of Psychiatry; 60(1):145-146. 
  • Tamai H, Kinugasa M. 2015. Pregnancy complicated by cyclic vomiting syndrome successfully treated with amitriptyline. Obstet Gynecol; 125(6):1487-1489.  
  • Tang KY. 2018. Amitriptyline poisoning at 34 weeks of pregnancy. Clin Toxicol (Phila); 56(4):301-303. 
  • Uguz F. 2017. Poor feeding and severe sedation in a newborn nursed by a mother on low dose amitriptyline. Breastfeed Med; 12:67-68. 
  • Uguz, F. 2021. A new safety scoring system for the use of psychotropic drugs during lactation. American journal of therapeutics; 28(1):e118-e126.  
  • Vree PH, et al. 1985. A newborn infant with amitriptyline poisoning. Ned Tijdschr Geneeskd; 129(19):910-912. 
  • Wang XY, et al. 2023. Antidepressant use during pregnancy and the risk for gestational diabetes: a systematic review and meta-analysis. J Matern Fetal Neonatal Med; 36(1):2162817.  
  • Weissman AM, et al. 2004. Pooled analysis of antidepressant levels in lactating mothers, breast milk, and nursing infants. The American J of Psychiatry; 161(6):1066-1078.  
  • Yoshida K, et al. 1997. Investigation of pharmacokinetics and possible adverse effects in infants exposed to tricyclic antidepressants in breast-milk. J Affective Disord; 43:225-37. 


Fluoxetine (Prozac®)

Selected References:

  • American Academy of Pediatrics. 2025. Recommendations for Prevention and Control of Influenza in Children, 2025–2026: Policy Statement. Pediatrics. Available at: https://doi.org/10.1542/peds.2025-073620. [Accessed 8/2025]. 
  • Becerra-Culqui TA, et al. 2022. Prenatal influenza vaccination or influenza infection and autism spectrum disorder in offspring. Clin Infect Dis; 75(7):1140-1148.  
  • Centers for Disease Control and Prevention. 2025-2026. Information for the Flu Season. Available at https://www.cdc.gov/flu/season/index.html. [Accessed 6/2026]. 
  • Centers for Disease Control and Prevention. 2025-2026. Flu Vaccine Safety and Pregnancy. Available at: https://www.cdc.gov/flu/vaccine-safety/vaccine-pregnant.html [Accessed 6/2026]. 
  • Centers for Disease Control and Prevention. 2025. Influenza Vaccine Safety Considerations during Pregnancy or while Breastfeeding. Available at: https://www.cdc.gov/flu/hcp/vax-summary/vaccine-safety-pregnant.html. [Accessed 6/2026]. 
  • Centers for Disease Control and Prevention. 2024. Vaccines for Family and Caregivers. Available at:  https://www.cdc.gov/vaccines-pregnancy/about/vaccines-family-caregivers.html. [Accessed 6/2026]. 
  • Conlin AMS, et al. 2018. A follow-up comparative safety analysis of pandemic H1N1 vaccination during pregnancy and risk of infant birth defects among U.S. military mothers. Vaccine; 36(20):2855-2860. 
  • Chaiken SR, et al. 2022. Cost-effectiveness of influenza vaccination during pregnancy. J Matern Fetal Neonatal Med; 35(25):5244-5252. 
  • Chambers CD, et al. 2013. Risks and safety of pandemic H1N1 influenza vaccine in pregnancy: birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants. Vaccine, 31(44):5026-5032.  
  • Committee on Infectious Diseases. 2024. Recommendations for Prevention and Control of Influenza in Children, 2024-2025: Technical Report. Pediatrics; 154(4):e2024068508.  
  • Donahue JG, e al. 2019. Inactivated influenza vaccine and spontaneous abortion in the Vaccine Safety Datalink in 2012-13, 2013-14, and 2014-15. Vaccine, 37(44):6673-6681.  
  • Fabiani M, et al. 2015. A/H1N1 pandemic influenza vaccination: A retrospective evaluation of adverse maternal, fetal and neonatal outcomes in a cohort of pregnant women in Italy. Vaccine, 33(19):2240-2247. 
  • Fell DB, et al. 2024. Effectiveness of influenza vaccination during pregnancy against laboratory-confirmed seasonal influenza among infants under 6 months of age in Ontario, Canada. J Infect Dis; 25;230(1):e80-e92. 
  • Foo DYP, et al. 2020. Early childhood health outcomes following in utero exposure to influenza vaccines: a systematic review. Pediatrics; 146(2):e20200375. 
  • Getahun D, et al. 2019. Association between seasonal influenza vaccination with pre- and postnatal outcomes. Vaccine, 37(13):1785-1791. Getahun D, et al. 2024.
  • Safety of the seasonal influenza vaccine in 2 successive pregnancies. JAMA Netw Open; 7(9):e2434857. Grohskopf LA, et al. 2024. Prevention and Control of
  • Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2024–25 Influenza Season. MMWR Recomm Rep; 2024;73(No. RR-5):1–25.  
  • Gunatilaka A, et al.2023. Protective effect of maternal immunization on birth outcomes: A data linkage study. Int J Gynaecol Obstet. 162(1):51-57.  
  • Gunnes N, et al. 2020. Seasonal and pandemic influenza during pregnancy and risk of fetal death: a Norwegian registry-based cohort study. Eur J Epidemiol, 35(4):371-379. 
  • Haberg S, et al. 2013. Risk of fetal death after pandemic influenza virus infection or vaccination. N Engl J Med, 368(4):333-340. 
  • Hall C, et al. 2025. Receipt of Tdap or Influenza vaccine during pregnancy and odds of clinical chorioamnionitis: A nested case-control study. Pharmacoepidemiol Drug Saf. 34(4):e70147. 
  • Hunagund S, et al. 2022. Effects of vaccination against influenza, pertussis, and COVID-19 on human milk antibodies: Current evidence and implications for health equity. Front Immunol; 13:910383. 
  • Hviid A, et al. 2017. Association between pandemic influenza A (H1N1) vaccination in pregnancy and early childhood morbidity in offspring. JAMA Pediatr, 171(3):239-248. 
  • Irving SA, et al. 2013. Trivalent inactivated influenza vaccine and spontaneous abortion. Obstet Gynecol, 121(1):159-165. 
  • Jamieson, Denise J.  et al. 2026, Maternal Immunization. Obstetrics & Gynecology; 147(5):p 661-678. 
  • Kharbanda EO, et al. 2013. Inactivated influenza vaccine during pregnancy and risks for adverse obstetric events. Obstet Gynecol, 122(3):659-667. 
  • Kharbanda EO, et al. 2017. First trimester influenza vaccination and risks for major structural birth defects in offspring. J Pediatr, 187:234-239.e4. 
  • Lee H, et al. 2025. Association of Influenza Vaccination During Pregnancy with Health Outcomes in Mothers and Children: A Population-Based Cohort Study. Clin Pharmacol Ther. 117(5):1381-1392. 
  • Legge A, et al. 2014. Rates and determinants of seasonal influenza vaccination in pregnancy and association with neonatal outcomes. CMAJ, 186(4):E157E163.  
  • Ludvigsson JF, et al. 2015. Maternal vaccination against H1N1 influenza and offspring mortality: population-based cohort study and sibling design. BMJ, 351:h5585. 
  • Ludvigsson JF, et al. 2020. Maternal influenza A(H1N1) immunization during pregnancy and risk for autism spectrum disorder in offspring : a cohort study. Ann Intern Med, 173(8):597-604. 
  • Malange V, et al, Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS). 2025. Influenza vaccination during early pregnancy and risk of major birth defects, US Birth Defects Study To Evaluate Pregnancy exposureS, 2014-2019. Vaccine. 59:127297. 
  • Maloney P, et al. 2026. Interim Estimates of 2025-26 Seasonal Influenza Vaccine Effectiveness – United States, September 2025-February 2026. MMWR Morb Mortal Wkly Rep; 12;75(9):116-123.  
  • McHugh L, et al. 2017. Birth outcomes for Australian mother-infant pairs who received an influenza vaccine during pregnancy, 2012-2014: the FluMum study. Vaccine, 35(10):1403-1409. 
  • Mehrabadi A, et al. 2021. Association of maternal influenza vaccination during pregnancy with early childhood health outcomes. JAMA, 325(22):2285-2293. 
  • Moro PL, et al. 2011. Adverse events in pregnant women following administration of trivalent inactivated influenza vaccine and live attenuated influenza vaccine in the Vaccine Adverse Event Reporting System, 1990-2009. Am J Obstet Gynecol, 204(2):146.e1-146.e1467.  
  • Moro PL et al. 2021. Reports of cell-based influenza vaccine administered during pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 2013-2020. Vaccine, 39(4):678-681. 
  • Munoz FM, et al. 2005: Safety of influenza vaccination during pregnancy. Am J Obstet Gynecol, 192(4):1098-1106. 
  • Nassar AH, et al. 2023. Vaccination in pregnancy. Int J Gynaecol Obstet; 162(1):18-23. 
  • Neuzil KM, et al. 1998. Impact of influenza on acute cardiopulmonary hospitalizations in pregnant women. Am J Epidemiol, 148(11):1094-1102. 
  • Nordin JD, et al. 2014. Maternal influenza vaccine and risks for preterm or small for gestational age birth. J Pediatr, 164(5):1051-1057.e2. 
  • Nwoji U. 2022. Seasonal influenza vaccine exposure in pregnancy: 5-year results from a pregnancy registry. Hum Vaccin Immunother, 18(1):1932213. 
  • Ohfuji S, et al. 2020. Safety of influenza vaccination on adverse birth outcomes among pregnant women: a prospective cohort study in Japan. Int J Infect Dis, 93:68-76. 
  • Palmsten K, et al. 2023. Influenza vaccination during pregnancy and risk of selected major structural congenital heart defects, National Birth Defects Prevention Study 2006-2011. Birth Defects Res; 115(1):88-95. 
  • Pasternak B, et al. 2012. Risk of adverse fetal outcomes following administration of a pandemic influenza A (H1N1) vaccine during pregnancy. JAMA, 308(2):165-174.  
  • Poehling KA, et al, New Vaccine Surveillance Network. 2011. Impact of maternal immunization on influenza hospitalizations in infants. Am J Obstet Gynecol, 204(6 Suppl 1):S141-8. 
  • Pool V, Iskander J. 2006 Safety of influenza vaccination during pregnancy. Am J Obstet Gynecolc 194:1200; author reply 1201. 
  • Regan AK, et al. 2024. Maternal influenza vaccination and associated risk of fetal loss: A claims-based prospective cohort study. Vaccine. 42(26):126256. 
  • Regan AK, et al. 2023. Risk of miscarriage in relation to seasonal influenza vaccination before or during pregnancy. Obstet Gynecol. 142(3):625-635.  
  • Robinson C, et al. 2022. A prospective cohort study on pregnancy outcomes of persons immunized with a seasonal quadrivalent inactivated influenza vaccine during pregnancy. Vaccines (Basel). 10(10):1577.  
  • Romano CJ et al. 2021. History of pandemic H1N1-containing influenza vaccination and risk for spontaneous abortion and birth defects. Vaccine, 39(44):6553-6562. 
  • Sakala IG, et al. 2023. Developmental and reproductive safety of Advax-CpG55.2™ adjuvanted COVID-19 and influenza vaccines in mice. Vaccine. :S0264-410X(23)01007-1.  
  • Sarna M et al. 2022 The risk of major structural birth defects associated with seasonal influenza vaccination during pregnancy: A population-based cohort study. Birth Defects Res. 114(19):1244-1256. 
  • Sarna M, et al. 2025. Neonatal and infant mortality after maternal influenza and pertussis vaccination: Probabilistically linked cohort study. Hum Vaccin Immunother; 21(1):2587307.  
  • Shaikh H, et al. 2023. Safety and protective effects of influenza vaccination in pregnant women on pregnancy and birth outcomes in Pune, India: A cross-sectional study. Vaccines (Basel). 11(6):1034. 
  • Sheffield J, et al. 2004. The efficacy and safety of influenza vaccination in pregnancy. Am J Obstet Gynecol, 191(6 Suppl):S66. 
  • Siston A, et al. 2010, Pandemic 2009 influenza A(H1N1) virus illness among pregnant women in the United States. JAMA, 303(15):1517-1525. 
  • Tamma et al. 2009. Safety of influenza vaccination during pregnancy. Am J Obstet Gynecol, 201(6):547-552. 
  • Tchuente V, et al 2026. Maternal influenza vaccination during pregnancy and the risk of adverse pregnancy and birth outcomes. Front Pharmacol; 5;16:1691111.  
  • Thompson MG, et al. 2018. Influenza vaccine effectiveness in preventing influenza-associated hospitalizations during pregnancy: a multi-country retrospective test negative design study, 2010–2016. Clin Infect Dis, 68(9):1444–1453. 
  • Xie S, et al. 2023. The association between maternal influenza vaccination during pregnancy and adverse birth outcomes in the United States: Pregnancy risk Assessment Monitoring System (PRAMS). Vaccine. 41(13):2300-2306. 
  • Zaman K, et al. 2008. Effectiveness of maternal influenza immunization in mothers and infants. N Engl J Med; 359(15):1555-1564. 
  • Zasztowt-Sternicka M, et al. 2025. Immunogenicity of inactivated quadrivalent influenza vaccine in pregnant women, including the level of postvaccination antibodies in umbilical cord blood. Vaccine. 19;53:127047. 
  • Zerbo O, et al. 2017. Association between influenza infection and vaccination during pregnancy and risk of autism spectrum disorder. JAMA Pediatr, 171(1):e163609. 
  • Zerbo O, et al. 2025. Influenza vaccination during pregnancy and infant influenza in the first 6 months of life. Obstet Gynecol; 146(2):e36-e42. 
  • Zhang X, et al. 2026. The Impact of Maternal Influenza Infection and Vaccination During Pregnancy on Birth Outcomes. Pediatr Infect Dis J. 10.1097/INF.0000000000005194. Epub ahead of print.