Selected References:

• English language version of Summary of Product Characteristics for Ilumetri (tildrakizumab) Accessed: https://www.ema.europa.eu/en/medicines/human/EPAR/ilumetri#product-information-section.
• Gisondi P, et al. 2022. Italian adaptation of EuroGuiDerm guideline on the systemic treatment of chronic plaque psoriasis. Ital J Dermatol Venerol. 157(Suppl. 1 to No. 1):1-78.
• Haycraft K, , et al. 2020. Outcomes of pregnancies from the tildrakizumab phase I–III clinical development programme. Br J Dermatol, 183: 184-186.
• Iluyma® Prescribing Information. Available online at https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761067s000lbl.pdf. Accessed on May 1, 2023.
• Owczarek W, et al. 2020. The use of biological drugs in psoriasis patients prior to pregnancy, during pregnancy and lactation: a review of current clinical guidelines. Postepy Dermatol Alergol. ;37(6):821-830.
• Smith C, , et al. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2020: a rapid update. Br. J. Dermatol., 183: 628-637.
• Yeung J, , et al. 2020. Management of Plaque Psoriasis With Biologic Therapies in Women of Child-Bearing Potential Consensus Paper. J Cutan Med Surg. 24(1_suppl):3S-14S.

Selected References:

• Cohen LS, et al. 2018. Risk of major malformations in infants following first trimester exposure to quetiapine. Am J Psychiatry, 175:1225–1231.
• Damkier P, & Videbech P. 2018. The safety of second‐generation antipsychotics during pregnancy: a clinically focused review. CNS Drugs, 32:351– 366.
• Ennis ZN., & Damkier P. 2015. Pregnancy exposure to olanzapine, quetiapine, risperidone, aripiprazole and risk of congenital malformations. A systematic review. Basic Clin Pharmacol Toxicol, 116:315-320.
• FDA Drug Safety Communication: Antipsychotic drug labels updated on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns: https://www.fda.gov/drugs/drugsafety/ucm243903.htm.
• Heinonen E, et al. 2022 Antipsychotic use during pregnancy and risk for gestational diabetes: a national register‑based cohort study in Sweden. CNS Drugs, 36:529–539.
• Holt RI, & Peveler RC. 2011. Antipsychotics and hyperprolactinaemia: mechanisms, consequences and management. Clin Endocrinol (Oxf); 74(2):141-147.
• Huybrechts KF, et al. 2016. Antipsychotic use in pregnancy and the risk for congenital malformations. JAMA Psychiatry, 73(9): 938-946.
• Kulkarni J, et al. 2014. A prospective cohort study of antipsychotic medications in pregnancy: the first 147 pregnancies and 100 one year old babies. PLoS ONE, 9(5):e947-988.
• Leutritz AL, et al. 2022. Psychotropic medication in pregnancy and lactation and early development of exposed children. British Journal of Clinical Pharmacology, 1-14.
• Levesque S, & Riley C. 2017. Fetal exposure to lamotrigine and quetiapine in two consecutive pregnancies. Arch Womens Ment Health; 20:237-339.
• Liu X, et al. 2022. Association of maternal antipsychotic prescription during pregnancy with standardized test scores of schoolchildren in Denmark. JAMA Internal Medicine; 182(10):1035-1043.
• Lusskin SI, et al. 2004. Prolactin elevation with ziprasidone. Am J Psychiatry; 161(10):1925.
• Peng M, et al. 2013. Effects of prenatal exposure to atypical antipsychotics on postnatal development and growth of infants: a case-controlled, prospective study. Psychopharmacology; 228:577–584.
• Shao P, et al. 2015. Effects of clozapine and other atypical antipsychotics on infants development who were exposed to as fetus: a post-hoc analysis. PLoS One; 10(4): 0123373.
• Sørensen MJ, et al. 2015. Risk of fetal death after treatment with antipsychotic medications during pregnancy. PLoS One; 10: 0132280.
• Staub L, et al. 2022. Association of antipsychotic drug exposure in pregnancy with risk of neurodevelopmental disorders a national birth cohort study. JAMA Internal Medicine, 182(5):522-533.
• Wichman CL. 2009. Atypical antipsychotic use in pregnancy: a retrospective review. Arch Womens Ment Health; 12:53–57.
• Yazdani-Brojeni P, et al. 2018. Quetiapine excretion into human breast milk. J Clin Psychopharmacol; 38:362–364.
• Zheng L, et al. 2022. Antidepressants and antipsychotics in human pregnancy: transfer across the placenta and opportunities for modeling studies. Journal of Clinical Pharmacology, 62(1):115-128.

Selected References:

• American Academy of Pediatrics. 2021. Breastfeeding during the COVID-19 pandemic. Available at URL: https://www.healthychildren.org/English/health-issues/conditions/COVID-19/Pages/Breastfeeding-During-COVID-19.aspx
• Academy of Breastfeeding Medicine. 2020. ABM Statement: Considerations for COVID-19 vaccination in lactation. Available at URL: https://abm.memberclicks.net/abm-statement-considerations-for-covid-19-vaccination-in-lactation
• American College of Obstetricians and Gynecologists. 2021. COVID-19 vaccination considerations for obstetric-gynecologic care. Available at URL: https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/covid-19-vaccination-considerations-for-obstetric-gynecologic-care
• American Society for Reproductive Medicine. 20021. Patient management and clinical recommendations during the coronavirus (COVID-19) pandemic. Available at URL: https://www.asrm.org/news-and-publications/covid-19/statements/patient-management-and-clinical-recommendations-during-the-coronavirus-covid-19-pandemic
• Blakeway H, et al. 2022. COVID-19 vaccination during pregnancy: coverage and safety. Am J Obstet Gynecol 226(2): e1-236.e14.
• Centers for Disease Control and Prevention. 2022. Interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the United States: Considerations involving pregnancy, lactation, and fertility. Available at URL: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#pregnancy-fertility
• Centers for Disease Control and Prevention. 2021. Vaccination safety for breastfeeding mothers. Available at URL: https://www.cdc.gov/breastfeeding/breastfeeding-special-circumstances/vaccinations-medications-drugs/vaccinations.html
• Citu IM, et al. 2022. Immunogenicity following administration of BNT162b2 and Ad26.COV2.S COVID-19 vaccines in the pregnant population during the third trimester. Viruses 14(2):307.
• Janssen Fact Sheet for Healthcare Providers Administering Vaccine. Revised 5/5/2022. Available at URL: https://www.fda.gov/media/146304/download
• Kachikis A, et al. 2021. Short-term reactions among pregnant and lactating individuals in the first wave of the COVID-19 vaccine rollout. JAMA Netw Open 4(8):e2121310.
• Kharbanda EO, et al. 2021. Spontaneous abortion following COVID-19 vaccination during pregnancy. JAMA 326(16):1629-1631.
• Lipkind HS, et al. 2022. Receipt of COVID-19 vaccine during pregnancy and preterm or small-for-gestational-age at birth — Eight integrated health care organizations, United States, December 15, 2020–July 22, 2021. MMWR Morb Mortal Wkly Rep 2022;71:26–30.
• Morgan JA, et al. 2022. Maternal outcomes after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in vaccinated compared with unvaccinated pregnant patients. Obstet Gynecol 139:107-109.
• Moro PL, et al. 2022. Post-authorization surveillance of adverse events following COVID-19 vaccines in pregnant persons in the vaccine adverse event reporting system (VAERS), December 2020 – October 2021. Vaccine 40(24):3389-3394.
• Zambrano LD, et al. 2020. Update: characteristics of symptomatic women of reproductive age with laboratory-confirmed SARS-CoV-2 infection by pregnancy status — United States, January 22–October 3, 2020. MMWR Morb Mortal Wkly Rep. 2020;69:1641–1647.

Selected References:

• Barenys M. 2009. Chronic exposure to MDMA (ecstasy) increases DNA damage in sperm and alters testes histopathology in male rats. Toxicol Lett 191:40-46
• Barneys M, et al. 2020. Developmental neurotoxicity of MDMA. A systematic literature review summarized in a putative adverse outcome pathway. Nurotoxicology 78:209-241.
• Committee on Drugs, American Academy of Pediatrics. 2001. The transfer of drugs and other chemicals into human milk. Pediatrics 108:776-89.
• Cooper AJ & Egleston CV. 1997. Accidental ingestión of Ecstasy by a toddler: Unusual cause for convulsion in a febrile child. J Accid Emerg Med 14(3):183-184.
• Draper ES, et al. 2008. Recreacional drug use. A major risk factor for gastroschisis? Am J Epidemiol 167(4):485-491.
• Fríguls B, et al. A comprehensive review of assay methods to determine drugs in breast milk and the safety of breastfeeding when taking drugs. Anal Bioanal Chem 397:1157–1179.
• Kolbrich EA, Goodwin RS, Gorelick DA, Hayes RJ, Stein EA, Huestis MA. 2008. Plasma pharmacokinetics of 3,4-methylenedioxymethamphetamine after controlled oral administration to young adults. Ther Drug Monit. Jun;30(3):320-32.
• Marcela C, et al. 2019. Stimulant use in pregnancy – An under-recognized epidemic among pregnant women. Clin Obstet 62(1):168-184.
• McElhatton P, et al.1999. Congenital anomalies after prenatal ecstasy exposure. Lancet 354:1441-2.
• Parrott A, et al. 2014. MDMA and heightened cortisol: a neurohormonal perspective on the pregnancy outcomes of mothers used ‘Ecstasy’ during pregnancy. Hum Psychopharmacol 29(1):1-7.
• Plessinger M, 1998. Prenatal exposure to amphetamines. Risks and adverse outcomes in pregnancy. Obstet Gynecol Clin North Am 25:119-38.
• Singer LT, et al. 2012. Neurobehavioral outcomes of infants exposed to MDMA (Ecstasy) and other recreational drugs during pregnancy. Neurotoxicol Teratol 34(3):303-10.
• Singer L. et al 2012. One-year outcomes of prenatal exposure to MDMA and other recreational drugs. Pediatrics 130(3): 407–413.
• Singer LT, et al. 2015. Developmental outcomes of 3,4-methylenedioxymethamphetamine (ecstasy)-exposed infants in the UK Hum Psychopharmacol 30(4): 290-294.
• Singer LT, et al. 2016. Motor delays in MDMA (ecstasy) exposed infants persist to 2 years. Neurotoxicol Teratol 54: 22-28.
• Smid MC, et al. 2019. Stimulant use in pregnancy: An under-recognized epidemic among pregnant women. Clin Obstet Gynecol 62(1):168-184.
• van Tonningen-van Driel MM, et al. 1999. [Pregnancy outcome after ecstasy use; 43 cases followed by the Teratology Information Service of the National Institute for Public Health and Environment (RIVM)]. Ned Tijdschr Geneeskd 143(1):27-31.
• Wouldes TA, Lester BM. 2019. Stimulants: How big is the problem and what are the effects of prenatal exposure? Semin Fetal Neonatal Med 24(2):155-160.

Selected References:

• Banihani SA, Khasawneh FH. 2018. Effect of lansoprazole on human sperm motility, sperm viability, seminal nitric oxide production, and seminal calcium chelation. Res Pharm Sci.13:460‐468.
• Dağlı U, Kalkan IH. 2017. Treatment of reflux disease during pregnancy and lactation. Turk J Gastroenterol. 2017 Dec;28(Suppl 1):S53-S56.
• Diav-Citrin O, et al. 2005. The safety of proton pump inhibitors in pregnancy: A multicenter prospective controlled trial. Aliment Pharmacol Ther; 21:269-75.
• Escoffier, J, Arnaud, B, Kaba, M, et al. 2020. Pantoprazole, a proton‐pump inhibitor, impairs human sperm motility and capacitation in vitro. Andrology. 8: 1795– 1804.
• Hastie R et al. 2019. Proton Pump Inhibitors and Preeclampsia Risk Among 157 720 Women. Hypertension. 73(5):1097-1103. doi: 10.1161/HYPERTENSIONAHA.118.12547.
• Kallen BA. 2001. Use of omeprazole during pregnancy–no hazard demonstrated in 955 infants exposed during pregnancy. Eur J Obstet Gynecol Reprod Biol. 96(1):63-68.
• Mahadevan U, Kane S. 2006. American Gastroenterological Association Institute technical review on the use of gastrointestinal medications in pregnancy. Gastroenterology.131(1):283-331
• Majithia R, Johnson DA. 2012. Are proton pump inhibitors safe during pregnancy and lactation? Evidence to date. Drugs. 72(2):171-179.
• Marshall JK, et al. 1998. Omeprazole for refractory gastroesophageal reflux disease during pregnancy and lactation. Can J Gastroenterol. 12(3):225-7.
• Matok I, et al. 2012. The safety of fetal exposure to proton-pump inhibitors during pregnancy. Dig Dis Sci.. 57(3):699-705.
• Pasternak B, Hviid A. 2010. Use of proton pump inhibitors in early pregnancy and the risk of birth defects. N Egl J Med. 363(22): 2114-2123.
• Plante L, et al. 2004. Excretion of pantoprazole in human breast. J Reprod Med. 2004;49:825-7.
• Saito J, et al. 2020. Esomeprazole During Pregnancy and Lactation: Esomeprazole Levels in Maternal Serum, Cord Blood, Breast Milk, and the Infant’s Serum. Breastfeed Med. 15(9):598-601. doi: 10.1089/bfm.2020.0175. Epub 2020 Jul 7.
• Ruigomez A, et al. 1999. Use of cimetidine, omeprazole, and ranitidine in pregnant women and pregnancy outcomes. Am J Epidemiol. 150(5):476-481.
• Thélin CS, Richter JE. 2020. Review article: the management of heartburn during pregnancy and lactation. Aliment Pharmacol Ther. 51(4):421-434. doi: 10.1111/apt.15611. Epub 2020 Jan 17. PMID: 31950535 Review.