Citalopram/Escitalopram (Celexa®/Lexapro®)

Selected References:  

  • Andersen JT, et al. 2014. Exposure to selective serotonin reuptake inhibitors in early pregnancy and the risk of miscarriage. Obstet Gynecol 124: 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
  • Bérard A, et al. 2017. SSRI and SNRI use during pregnancy and the risk of persistent pulmonary hypertension of the newborn. Br J Clin Pharmacol. 83(5):1126-1133. 
  • Berle JO, et al. 2004. Breastfeeding during maternal antidepressant treatment with serotonin reuptake inhibitors: infant exposure, clinical symptoms, and cytochrome P450 genotypes. J Clin Psychiatry. 65:1228-1234.
  • Bonari L, et al. 2004. Perinatal risks of untreated depression during pregnancy. Can J Psychiatry 49(11):726-
  • Chambers CD, et al. 2006. Selective serotonin-reuptake inhibitors and risk of persistent pulmonary hypertension of the newborn. N Engl J Med 354:579-587.
  • Colvin L, et al. Dispensing patterns and pregnancy outcomes for women dispensed selective serotonin reuptake inhibitors in pregnancy. Birth Defects Research Part A: Clinical and Molecular Teratology 91:142-152
  • Cornet MC, et al. Maternal treatment with selective serotonin reuptake inhibitors during pregnancy and delayed neonatal adaptation: a population-based cohort study. Arch Dis Child Fetal Neonatal Ed 18;109(3):294-300.
  • Den Besten-Bertholee D, et al. Sertraline, citalopram and paroxetine in lactation: passage into breastmilk and infant exposure. Front Pharmacol 22(15):1414677.
  • Desaunay P, et al. 2024. Antidepressants and fetal death: A systematic review and disproportionality analysis in the WHO safety database (VigiBase). Psychiatry Res 339: 
  • Einarson A, et al. 2009. Incidence of major malformations in infants following antidepressant exposure in pregnancy: results of a large prospective cohort study. Can J Psychiatry 54(4):242-246.
  • Ericson A, et al. 1999. Delivery outcome after the use of antidepressants in early pregnancy. Eur J Clin Pharmacol 55:503-508.
  • Gao SY, et al. 2018. Selective serotonin reuptake inhibitor use during early pregnancy and congenital malformations: a systematic review and meta-analysis of cohort studies of more than 9 million births. BMC Med 16(1):205.
  • Gram MA, et al. Antidepressant exposure patterns during pregnancy and risk of adverse newborn outcomes. Psychiatry Res 342:116274.
  • 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.
  • Heikkinen T, et al. 2002. Citalopram in pregnancy and lactation. Clin Pharmacol Ther 72:184-191.
  • Jimenez-Solem E, et al. 2012. Exposure to selective serotonin reuptake inhibitors and the risk of congenital malformations: a nationwide cohort study. BMJ Open:2e001148 doi:10.1136/bmjopen-2012-001148. 
  • Jordan AE, et al. 2008. Serotonin reuptake inhibitor use in pregnancy and the neonatal behavioral syndrome. J Matern Fetal Neonatal Med 21(10):745-751.
  • Huybrechts KF, et al. 2014. Antidepressant use in pregnancy and the risk of cardiac defects. N Engl J Med. 370(25):2397-407.
  • Kallen BAJ and Otterblad Olausson P. 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.
  • Kallen B and Otterblad Olausson P. 2008. Maternal use of selective serotonin re-uptake inhibitors and persistent pulmonary hypertension of the newborn. Pharmacoepidemiol Drug Saf 17:801-806.
  • Kieler H, et al. 2012. Selective serotonin reuptake inhibitors during pregnancy and risk of persistend pulmonary hypertension in the newborn: population based cohort study from the five Noridc 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.
  • 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.
  • Milosavljević JZ, et al. 2022.The effects of selective serotonin reuptake inhibitors on male and female fertility: a brief literature review. Int J Psychiatry Clin Pract. 26(1):43-49. 
  • Morales DR, et al. Antidepressant use during pregnancy and risk of autism spectrum disorder and attention deficit hyperactivity disorder: systematic review of observational studies and methodological considerations. BMC Med. 16:1–14.
  • Moses-Kolko, EL, et al. 2005. Neonatal signs after late in utero exposure to serotonin reuptake inhibitors:  Literature review and implications for clinical applications. JAMA 293:2372-2383.
  • Newport DJ, et al. 2002. The treatment of postpartum depression: Minimizing infant exposure. J Clin Psychiatry  63(Suppl 7): 31-44.
  • Rampono J, et al. 2006. Transfer of escitalopram and its metabolite demethylescitalopram into breastmilk. Br J Clin Pharmacol 3:316-22.
  • Reefhuis J, et al. 2015. Specific SSRIs and birth defects: bayesian analysis to interpret new data in the context of previous Bmj. 351:h3190.
  • Reis M and Kallen B. 2010. Delivery outcome after maternal use of antidepressant drugs in pregnancy: an update using Swedish data. Psychol Med 40(10):1723-1733. 
  • Sivojelezova A, et al. 2005. Citalopram use in pregnancy: prospective comparative evaluation of pregnancy and fetal outcome. Am J Obstet Gynecol 193:2004-9.
  • Sjaarda LA, et al. Urinary selective serotonin reuptake inhibitors across critical windows of pregnancy establishment: A prospective cohort study of fecundability and pregnancy loss. Fertil Steril 114:1278-1287.
  • Tabacova SA, et al. 2004. Adverse developmental events reported to FDS in association with maternal citalopram treatment in Birth Defects Res 70:361.
  • 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).
  • Weissman AM, et al. 2004. Pooled analysis of antidepressant levels in lactating mothers, breast milk, and nursing infants. Am J Psychiatry. 161:1066-1078.


Citalopram/Escitalopram (Celexa®/Lexapro®)

Selected References:

  • Almas S, et al. 2016. Management of multiple sclerosis in the breastfeeding mother. Mult Scler Int:6527458. 
  • Amato MP and Portaccio E. 2015. Fertility, Pregnancy and Childbirth in Patients with Multiple Sclerosis: Impact of Disease-Modifying Drugs. CNS Drugs 29:207-220. 
  • Andersen JB, et al. 2018. Pregnancy outcomes in men and women treated with teriflunomide. A population-based nationwide Danish registry study. Frontiers in Immunology 9(2706):1-7.
  • Aubagio® Prescribing Information. 12/2022. Available online at http://products.sanofi.us/aubagio/aubagio.pdf, accessed 12/2022.  
  • Barataud-Reilhac A, et al. 2020. Teriflunomide-exposed pregnancies in French cohort of patients with multiple sclerosis. Neurol Clin Pract 10(4): 287-297.  
  • Cree BA. 2013. Update on reproductive safety of current and emerging disease-modifying therapies for multiple sclerosis. Mult Scler.19:835-43.  
  • Chambers CD, et al. 2010. Birth outcomes in pregnant women taking leflunomide. Arthritis Rheu. 62(5):1494-503. 
  • Chambers C, et al. 2007. Are new agents used to treat rheumatoid arthritis safe to take during pregnancy? Organization of Teratology Information Specialists (OTIS) study. Motherisk Update. 53(3):409-412. 
  • Cassina M, et al. 2012. Pregnancy outcome in women exposed to Leflunomide before or during pregnancy. Arth & Rheum 64(7):2085-2094. 
  • D’Aleo G, et al. 2020. Twin pregnancy outcome following teriflunomide treatment in a relapsing-remitting multiple sclerosis patient: A case report. Medicine (Baltimore) 99(28):e21212. 
  • Davenport L, et al. 2014. Teriflunomide: non-clinical evaluation demonstrates no effect on sperm DNA or male fertility [abstract]. Neurology 82(10 Supp):P2.233. 
  • De Santis M, et al. 2005. Paternal and maternal exposure to leflunomide: pregnancy and neonatal outcome. Ann Rheum Dis 64:1096-1097. 
  • Dobson R, et al. 2019. UK consensus on pregnancy in multiple sclerosis: ‘Association of British Neurologists’ guidelines. Pract Neurol. 19:106–14 
  • Gold R and Wolinsky JS. 2011. Pathophysiology of multiple sclerosis and the place of teriflunomide. Acta Neurol Scand 124(2):75-84. 
  • Henson LJ, et al. 2014. Updated pregnancy outcomes in patients and partners of patients in the terflunomide clinical trial program [abstract]. Neurology 82(10 Supp): P4.161. 
  • Kieseier B, et al. 2012. Pregnancy outcomes from the teriflunomide clinical development programme: retrospective analysis of the teriflunomide clinical trial database (Poster 737). Mult Scler;18(Suppl 4):328. 
  • Losee JE and Mason AC. 2005. Deformational plagiocephaly: diagnosis, prevention, and treatment. Clin Plastic Surg 31;53-64 
  • Lu E, et al. 2013. Safety of disease-modifying drugs for multiple sclerosis in pregnancy: current challenges and future considerations for effective pharmacovigilance. Expert Reviews 13(3):251-61. 
  • O’Connor P, et al. 2011: Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med 365(14):1293-1303.  
  • Varytė G, et al. 2021. Pregnancy and multiple sclerosis: an update. Curr Opin Obstet Gynecol 33(5):378-383. 
  • Vukusic  S, et al. 2020. Pregnancy outcomes in patients with multiple sclerosis treated with teriflunomide: Clinical study data and 5 years of post-marketing experience. Mult Scler 26(7):829-836.  
  • Weber-Schoendorfer C, et al. 2017. Leflunomide – A human teratogen? A still not answered question. An evaluation of the German Embryotox pharmacovigilance database. Reprod Toxicol 71:101-107. 

 


Citalopram/Escitalopram (Celexa®/Lexapro®)

Selected References:  

  • Bach V, et al. 1989. A randomized comparison between midazolam and thiopental for elective cesarean section anesthesia. III. Placental transfer and elimination in neonates. Anesth Analg. 68:238-42. 
  • Frolich MA, et al. 2006. A single dose of fentanyl and midazolam prior to Cesarean section have no adverse neonatal effects. Can J Anaesth. 53(1):79-85. 
  • Iyilikci L, et al. 2007. Sedation for endoscopic retrograde cholangiopancreatography (ERCP) in a pregnant patient. J Anesth. 21(1):69-71. 
  • Kanto J, et al. 1984. Pharmacokinetics and sedative effect of midazolam in connection with cesarean section performed under epidural analgesia. Acta Anaesthesiol Scand 28:116-8. 
  • Kelly LE, et al. 2012. Neonatal Benzodiazepines Exposure during Breastfeeding. J Pediatr. 161(3):448-451.
  • Koitabashi T, et al. 1997. Intravenous midazolam passage into breast milk. J Anesth. 11:242-3. 
  • Nitsun M, et al. 2006. Pharmacokinetics of midazolam, propofol, and fentanyl transfer to human breast milk. Clin Pharmacol 79:549-57. 
  • Olutoye OA, et al. 2018. Food and Drug Administration warning on anesthesia and brain development: implications for obstetric and fetal surgery. Am J Obstet 218(1):98-102.
  • Senel AC, et al. 2014. Premedication with midazolam prior to caesarean section has no neonatal adverse effects. Braz J Anesthesiol. 64(1):16-21. 
  • Shergill AK, et al. 2012. Guidelines for endoscopy in pregnant and lactating women. Gastrointest Endosc. 76(1):18-24. 
  • Swanson RJ, Leavitt MG. 1992. Fertilization and mouse embryo development in the presence of midazolam. Anesth Analg 75: 549-54, 1992. 
  • Uguz A New Safety Scoring System for the Use of Psychotropic Drugs During Lactation. Am J Ther. 2021 Jan-Feb 01;28(1):e118-e126. doi: 10.1097/MJT.0000000000000909. PMID: 30601177.
  • Wilson CM, et al. 1987. A comparison of the early pharmacokinetics of midazolam in pregnant and nonpregnant women. Anaesthesia. 42:1057-62. 
  • Xu J, et al 2019. Early Developmental Exposure to Repetitive Long Duration of Midazolam Sedation Causes Behavioral and Synaptic Alterations in a Rodent Model of Neurodevelopment. J Neurosurg Anesthesiol. 31(1):151- 
  • Young C, et al. 2005. Potential of ketamine and midazolam, individually or in combination, to induce apoptotic neurodegeneration in the infant mouse brain. Br J Pharmacol. 146(2):189-97.


Citalopram/Escitalopram (Celexa®/Lexapro®)

Selected References:

  • Holt RI, Peveler RC. 2011. Antipsychotics and hyperprolactinemia: mechanisms, consequences and management. Clin Endocrinol (Oxf). 74(2):141-7.
  • Einarson A, Boskovic R. 2009. Use and safety of antipsychotic drugs during pregnancy. J Psychiatr Pract. 15(3):183-92.
  • Loxitane® Product Label. Revised 2017. Available at URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017525s051,017658s038,018039s024lbl.pdf
  • Maguire GA. 2002. Prolactin elevation with antipsychotic medications: mechanisms of action and clinical consequences. J Clin Psychiatry. 63 Suppl 4:56-62.
  • Parikh T, et al. 2014. Antipsychotic drugs and safety concerns for breast-feeding infants. South Med J. 107(11):686-8.
  • Torre, DL, and Falorni, A. 2017. Pharmacological causes of hyperprolactinemia. Therapeutics and clinical risk management. 3(5): 929-51.


Citalopram/Escitalopram (Celexa®/Lexapro®)

Selected References: 

  • American College of Obstetricians and Gynecologists. Urinary tract infections in pregnant individuals. Clinical Consensus No. 4. Obstet Gynecol;142:435–45.
  • Ailes EC, et al. 2018. Antibiotics dispensed to privately insured pregnant women with urinary tract infections – United States, 2014. MMWR Morb Mortal Wkly Rep, 67(1):18-22.
  • Andersen JT et al. 2013. Trimethoprim use in early pregnancy and the risk of miscarriage: a register-based nationwide cohort study. Epidemiol Infect, 141:1749-1755. 
  • Cooper M, et al. 2014. Clinical Inquiry: how best to treat UTIs in women who breastfeed? J Fam Pract, 63(2):102-3. 
  • Crider KS, et al. 2009. Antibacterial medication use during pregnancy and risk of birth defects. Arch Pediatr Adolesc Med,163:978-985. 
  • Crowe HM, et al. 2021. Antibiotics and fecundability among female pregnancy planners: a prospective cohort study. Hum Reprod, 18;36(10):2761-2768.
  • Czeizel AE, et al. 2001. The teratogenic risk of trimethoprim-sulfonamides: a population-based case-control study. Reprod Toxicol,15:637-646. 
  • Czeizel AE, et al. 2004. Possible association between different congenital abnormalities and use of different sulfonamides during pregnancy. Congenital Abnormalities, 44:79-86. 
  • Ford N, et al. 2014. Safety of co-trimoxazole in pregnancy: a systematic review and meta-analysis. J Acquir Immune Defic Syndr, 66(5): 512-521.
  • Hansen C, et al. 2016. Trimethoprim-sulfonamide use during the first trimester of pregnancy and the risk of congenital anomalies. Pharmacoepidemiol Drug Saf, 25(2):170-8.
  • Hernandez S, et al. 2000. Folic acid antagonists during pregnancy and the risk of birth defects. N Engl J Med, 343:1608-1614. 
  • Hernandez-Diaz S, et al. 2001. Neural tube defects in relation to use of folic acid antagonists during pregnancy. Am J Epidemiol, 153:961-968. 
  • Klarskov P et al. 2013. Short-acting sulfonamides near term and neonatal jaundice. Obstet Gynecol, 122:105-110. 
  • Li P, et al. 2020. Maternal exposure to sulfonamides and adverse pregnancy outcomes: A systematic review and meta-analysis. PLoS One, 15(12):e 
  • Molgaard-Nielsen D, Hviid A. 2012. Maternal use of antibiotics and the risk of orofacial clefts: a nationwide cohort Pharmacoepidemiol Drug Saf, 21:246-253. 
  • Murdia A, et al. 1978. Sulpha-trimethoprim combinations and male fertility. Lancet, 2:375-376. 
  • Muanda FT et al. 2018. Use of trimethoprim-sulfamethoxazole during pregnancy and risk of spontaneous abortion: a nested case control study. BJCP, 84(6):1198-1205.
  • NIH-U.S. National Library of Medicine (2021). LABEL: BACTRIM DS- sulfamethoxazole and trimethoprim tablet. (nih.gov) Available at DailyMed https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm. Accessed November 14, 2024
  • Santos F et al. 2011. Exposure to anti-infective drugs during pregnancy and the risk of small-for-gestational-age newborns: a case-control study. BJOG, 118:1374-1382. 
  • Wen SW, et al. 2008. Maternal exposure to folic acid antagonists and placenta-mediated adverse pregnancy outcomes. CMAJ, 179:1263-1268. 
  • Yang J et al. 2011. Exposure to trimethoprim/sulfamethoxazole but not other FDA category C and D anti-infectives is associated with increased risks of preterm birth and low birth weight. Int J Infect Dis, 15:e336- 341. 
  • Yu PA, et al. 2020. Safety of antimicrobials during pregnancy: a systematic review of antimicrobials considered for treatment and postexposure prophylaxis of p Clin Infect Dis, 70(70 Suppl 1):S37-S50.