
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.
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- 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.
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- 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.
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- 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.
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- 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.
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- 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.
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- 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.
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- 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.
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- Liberis A, et al. 2021. Lipid Disorders in Pregnancy. Curr Pharm Des. 27(36):3804-3807.
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- 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.
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- 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.
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- 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.
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- 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.
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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].
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- 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.
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- Foo DYP, et al. 2020. Early childhood health outcomes following in utero exposure to influenza vaccines: a systematic review. Pediatrics; 146(2):e20200375.
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- 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.
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- 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.
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