Selected References:

• Ahrens KA, et al. 2013. Antiherpetic Medication Use and the Risk of Gastroschisis: Findings From the National Birth Defects Prevention Study, 1997-2007. Paediatric and Perinatal Epidemiology. 27(4):340-345. 
• Braig S, et al. 2001. Acyclovir prophylaxis in late pregnancy prevents recurrent genital herpes and viral shedding. Eur J Obstet Gynecol Reprod Biol. 96(1):55-58. Centers for Disease Control. 1993. Pregnancy outcomes following systemic prenatal acyclovir exposure – June 1, 1984-June 30, 1993. MMWR. 42(41):806-809. 
• Douglas JM Jr, et al. 1988. A double-blind, placebo-controlled trial of the effect of chronically administered oral acyclovir on sperm production in men with frequently recurrent genital herpes. J Infect Dis. 157(3):588-593. 
• Drake AL, et al. 2012. Infant Safety During and After Maternal Valacyclovir Therapy in Conjunction with Antiretroviral HIV-1 Prophylaxis in a Randomized Clinical Trial. PloS One. 7(4):e34635. 
• Drake AL, et al. 2012. Valacyclovir Suppressive Therapy Reduces Plasma and Breast Milk HIV-1 RNA Levels During Pregnancy and Postpartum: A Randomized Trial. J Infect Dis. 205(3):366-375. 
• Kallia V, et al. 2025. Efficacy and Safety of Antivirals in Lactating Women with Herpesviridae Infections: A Systematic Review. Viruses. 17(4):538. 
• Kimberlin DF, et al. 1998. Pharmacokinetics of oral valacyclovir and acyclovir in late pregnancy. Am J Obstet Gynecol. 179(4):846-851.  
• Longbottom K, et al. 2024. Neonatal varicella. Arch Dis Child. 109(8):610-615.  
• Pasternak B, et al. 2010. Use of acyclovir, valacyclovir, and famciclovir in the first trimester of pregnancy and the risk of birth defects. JAMA 304(8):859-866. 
• Prober CG. 2001. Management of the neonate whose mother received suppressive acyclovir therapy during late pregnancy. Pediatr Infect Dis J. 20(1):90-91. 
• Ratanajamit C, et al. 2003. Adverse pregnancy outcome in women exposed to acyclovir during pregnancy: a population-based observational study. Scand J Infect Dis. 35(4):255-259. 
• Sheffield JS, et al. 2002. Acyclovir concentrations in human breast milk after valaciclovir administration. Am J Obstet Gynecol. 186(1):100-102. 

Selected References:

• Akhtar NH et. al. 2022. The use of dupilumab in severe atopic dermatitis during pregnancy: a case report. Allergy Asthma Clin Immunol. 18(1):9.  
• Avallone G, et al. 2024. Association between maternal dupilumab exposure and pregnancy outcomes in patients with moderate-to-severe atopic dermatitis: A nationwide retrospective cohort study. J Eur Acad Dermatol Venereol. 6(1)1-10. 
• Bosma AL, et al. 2021. Paternal and maternal use of dupilumab in patients with atopic dermatitis: a case series. Clin Exp Dermatol. 46(6):1089-1092. 
• Center for Drug Evaluation and Research (CDER). Dupilumab pharmacology review. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761055Orig1s000PharmR.pdf.  Accessed 23 June 2026. 
• Chan T, et al, 2020. Taiwanese Dermatological Association consensus for the management of atopic dermatitis: A 2020 update. J Formos Med Assoc. 120(1:Pt2):429-442. 
• Chopra CR, et al. 2025. Maternal, Fetal, and Labour Outcomes of Dupilumab Use for Atopic Dermatitis During Pregnancy: A Systematic Review. J Cutan Med Surg. 29(1):51-55.  
• Costley M, Murphy B. 2022. Severe atopic dermatitis treated successfully with dupilumab throughout pregnancy. 2022. Clin Exp Dermatol 47(5):960-961. 
• Di Lernia V, Peccerillo F, 2024. Long-Term Follow-Up of Dupilumab Treatment During Conception, Pregnancy and Lactation. Indian J Dermatol. 69(2):193-195.  
• Escolà H, et al. 2023. Dupilumab for atopic dermatitis during pregnancy and breastfeeding: Clinical experience in 13 patients. J Eur Acad Dermatol Venereol. 37(9)p.e1156-e1160. 
• Gracia-Darder I, et al. 2022). Patient with atopic dermatitis, hyper IgE syndrome and ulcerative colitis, treated successfully with dupilumab during pregnancy. Dermatol Ther. 35(2) e15247. 
• Hong N, et al. 2024. Atopic dermatitis treated safely with dupilumab during pregnancy and lactation: A case series of four patients. Australas J Dermatol. 00:1-4. 
• Heilskov S, et al. 2020. Immunosuppressive and Immunomodulating Therapy for Atopic Dermatitis in Pregnancy: An Appraisal of the Literature. Dermatol Ther (Heidelb) 10(6): 1215–1228. 
• Jang W, et al. 2025. Use of Biologics to Treat Asthma during Pregnancy and Adverse Events in Pregnant Women and Newborns: A Global Pharmacovigilance Analysis. Int Arch Allergy Immunol. 186(9):875-888.  
• Kage P, et al. 2020. A case of atopic eczema treated safely with dupilumab during pregnancy and lactation. Journal of the European Academy of Dermatology and Venereology: JEADV, 34(6), e256–e257. 
• Kage P, et al. 2021. Case of atopic eczema treated with dupilumab throughout conception, pregnancy, and lactation. J Dermatol 48(10):E484-E485. 
• Khamisy-Farah R, et al. 2021. Safety profile of Dupilumab during pregnancy: a data mining and disproportionality analysis of over 37,000 reports from the WHO individual case safety reporting database (VigiBase™) Eur Rev Med Pharmacol Sci. 25(17):5448-5451. 
• Lobo Y, et al. 2021. Atopic Dermatitis Treated Safety with Dupilumab during Pregnancy: A Case Report and Review of the Literature. Case Rep Dermatol. 13:248–256. 
• Metko, D. et al. 2024. A real-world study of dupilumab in patients with atopic dermatitis including patients with malignancy and other medical comorbidities. JAAD Int. 15:5-11. 
• Mian M, et al. 2020. Dupilumab for the treatment of severe atopic dermatitis in a pregnant patient: A case report. JAAD Case Reports. 6(10), 1051–1052.   
• Napolitano M, et al. 2021. New emergent therapies for atopic dermatitis: A review of safety profile with respect to female fertility, pregnancy, and breastfeeding. Dermatol Ther. 34:e14475.   
• Preuß S, et al. 2025. Dupilumab shows no elevated risk for maternal adverse pregnancy outcomes: A propensity-matched cohort study. J Eur Acad Dermatol Venereol. 39(9):1576-1587.  
• Riquelme-Mc Loughlin C, Mascaró JM Jr. 2021. Treatment of pemphigoid gestationis with dupilumab. Clin Exp Dermatol. 46(8):1578-1579.  
• Sánchez-García V, et al 2025. Safety of dupilumab therapy for atopic dermatitis during pregnancy: A systematic review and meta-analysis. Acta Derm Venereol.105:adv41307.  
• Sanofi-Aventis U.S. Dupixent® Prescribing Information. Available online at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?.  Accessed on 23 June 2026.  
• Vestergaard C, et al. 2019. European task force on atopic dermatitis position paper: treatment of parental atopic dermatitis during preconception, pregnancy and lactation period. J Eur Acad Dermatol Venereol. 33(9):1644-1659. 

Selected References:

• Barrau M, et al. 2023. What should we know about drug levels and therapeutic drug monitoring during pregnancy and breastfeeding in inflammatory bowel disease under biologic therapy? J Clin Med; 12(23):7495. 
• Bell C, et al. 2021. Systematic review and meta-analysis: Safety of vedolizumab during pregnancy in patients with inflammatory bowel disease. J Gastroenterol Hepatol; 36(10):2640-2648.  
• Caballero-Mateos AM, et al. 2023. IBD and motherhood: A journey through conception, pregnancy and beyond. J Clin Med; 12(19):6192. 
• Chambers CD, et al. 2026. Birth outcomes in women who have taken vedolizumab in pregnancy: Results from the vedolizumab pregnancy exposure registry. Am J Gastroenterol; 1;121(3):720-732. 
• Chugh R. 2023. Maternal and neonatal outcomes in vedolizumab and ustekinumab exposed pregnancies: Results from the PIANO registry. Am J Gastroenterol; 1;119(3):468-476. 
• Ding N, et al. 2022. Management of biologics in pregnant, lactating patients with inflammatory bowel disease and the impact on neonatal vaccination: A systematic review of clinical practice guidelines and consensus statements. J Clin Pharm Ther; 47(12):1952-1965. 
• Ernest-Suarez K, et al. 2025. Live rotavirus vaccination appears low-risk in infants born to mothers with inflammatory bowel disease on biologics. Clin Gastroenterol Hepatol; 23(5):835-845. 
• Gisbert JP, et al. 2023. Vaccines in children exposed to biological agents in utero and/or during breastfeeding: Are they effective and safe? J Crohns Colitis; 17 (6):995-1009. 
• Gisbert JP, et al. 2020. Safety of new biologics (vedolizumab and ustekinumab) and small molecules (tofacitinib) during pregnancy: A review. Drugs; 80(11):1085-1100.  
• Honap S, et al. 2023. An update on the safety of long-term vedolizumab use in inflammatory bowel disease. Expert Opin Drug Saf; 22 (9):767-776. 
• Julsgaard M, et al. 2017. Vedolizumab safety in pregnancy and newborn outcomes. Gut; 66(10):1866-1867.  
• Julsgaard M, et al. 2018. Vedolizumab concentrations in the breast milk of nursing mothers with inflammatory bowel disease. Gastroenterology; 154: 752-765.  
• Lahat A, et al. 2018. Vedolizumab levels in breast milk of nursing mothers with inflammatory bowel disease. J Crohns Colitis; 12:120-3.  
• Lamb CA, et al. 2019. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut; 68(Suppl 3):s1-s106.  
• Laube R, et al. 2021. Use of medications during pregnancy and breastfeeding for Crohn’s disease and ulcerative colitis. Expert Opin Drug Saf; 20(3):275-292.  
• Mahadevan U, et al. 2017. Vedolizumab exposure in pregnancy: Outcomes from clinical studies in inflammatory bowel disease. Aliment Pharmacol Ther; 45:941-950.  
• Mahadevan U, et al. 2017. Editorial: vedolizumab in pregnancy – is gut selectivity as good for baby as it is for mum? Authors’ reply. Aliment Pharmacol Ther; 45(9):1284. 
• Meyer A, et al. 2025. Safety of vedolizumab and ustekinumab compared with anti-TNF in pregnant women with inflammatory bowel disease. Clin Gastroenterol Hepatol; 23(1):144-153.e22. 
• Mitrova K, et al. 2022. Safety of ustekinumab and vedolizumab during pregnancy-Pregnancy, neonatal, and infant outcome: A prospective multicentre study. J Crohn’s Colitis; 16(12):1808-1815. 
• Moens A, et al. 2019. Outcome of pregnancies in female patients with inflammatory bowel diseases treated with vedolizumab. J Crohns Colitis; 13(1):12-13.  
• Moens A, et al. 2020. Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti-TNF or conventional therapy: results of the European CONCEIVE study. Aliment Pharmacol Ther; 51(1):129-138.  
• Nguyen B, et al. 2026. Safety of vedolizumab in pregnancy: An updated systematic review and comprehensive meta-analysis. Journal of Clinical Gastroenterology; 60(3):225-231. 
• Nielsen OH. 2022. Biologics for inflammatory bowel disease and their safety in pregnancy: A systematic review and meta-analysis. Clin Gastroenterol Hepatol; 20(1):74-87. 
• Pingeon O, et al. 2026. Safety of advanced therapies during pregnancy in women with immune-mediated inflammatory diseases: a systematic review and meta-analysis. J Crohns Colitis; 8;20(5):jjag045. 
• Prentice R, et al. 2025. Vedolizumab and ustekinumab levels in pregnant women with inflammatory bowel disease and infants exposed in utero. Clin Gastroenterol Hepatol; 23(1):124-133.e7. 
• Pugliese D, et al. 2024. New drugs for the treatment of IBD during conception, pregnancy, and lactation. Dig Liver Dis; 56(2):235-241. 
• Rosario M, et al. 2017. A review of the clinical pharmacokinetics, pharmacodynamics, and immunogenicity of vedolizumab. Clin Pharmacokinet; 56(11): 1287–1301.  
• Sheridan J, et al. 2017. Letter: Vedolizumab in Pregnancy. J Crohns Colitis; 11(8):1025-1026. 
• Shitrit AB-G A, et al. 2019. Exposure to vedolizumab in IBD pregnant women appears of low risk for mother and neonate: A first perspective comparison study. Am J Gastroenterol; 114(7): 1172-1175.   
• Sun W, et al. 2021. Vedolizumab concentrations in breast milk: Results from a prospective, postmarketing, milk-only lactation study in nursing mothers with inflammatory bowel disease. Clin Pharmacokinet; 60:811-8.  
• Takeda Pharmaceuticals America, Inc. 2026. Entyvio product label. Available at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6e94621c-1a95-4af9-98d1-52b9e6f1949c  

Selected References:

• Ahn KH, et al. 2015. Pregnancy outcomes with paternal exposure to finasteride, a synthetic 5-alpha-reductase inhibitor: a case-series. J Clin Toxicol. 5:2 
• AlSaad D, et al. 2018. Finasteride use during pregnancy and early neonatal outcome: a case report. Int J Clin Pharm. 40(4): 803-805.  
• Amory JK, et al. 2007. The effect of 5- alpha-reductase inhibition with dutasteride and finasteride on semen parameters and serum hormones in healthy men. J Clin Endocrinol Metab. 92:1659-1665.  
• Anderson CA, Clark RL. 1990. External genitalia of the rat: normal development and the histogenesis of 5 alpha-reductase inhibitor-induced abnormalities. Teratology. 42:483-496. 
• Bowman CJ, et al. 2003. Effects of in utero exposure to finasteride on androgen-dependent reproductive development in the male rat. Toxicol Sci. 74:393-406. 
• Carlin JR, et al. 1992. Disposition and pharmacokinetics of (14C) finasteride after oral administration in humans. Drug Metab Dispos. 20(2):148-155. 
• Cather JC, et al. 1999. Finasteride – An update and review. Cutis. 64:167-172. 
• Ciotta L, et al. 1995. Clinical and endocrine effects of finasteride, a 5(alpha)-reductase inhibitor, in women with idiopathic hirsutism. Fertil Steril. 64:299-306. 
• Clark RL, et al: Critical developmental periods for effects on male rat genitalia induced by finasteride, a 5(alpha)-reductase inhibitor. Toxicol Appl Pharmacol. 119:34-40. 
• Clark RL, et al. 1990. External genital abnormalities in male rats exposed in utero to finasteride, a 5-alpha reductase inhibitor. Teratology. 42:91-100. 
• Falsetti L, et al. 1997. Treatment of hirsutism by finasteride and flutamide in women with polycystic ovary syndrome. Gynecol Endocrinol. 11(4):251-257. 
• Husmann DA, McPhaul MJ. 1991. Time-specific androgen blockade with flutamide inhibits testicular descent in the rat. Endocrinology. 129(3):1409-1416. 
• Gupta AK, Talukder M. 2022. Topical finasteride for male and female pattern hair loss: Is it a safe and effective alternative? J Cosmet Dermatol. 21(5), 1841-1848.  
• Khera M, et al. 2020. Penile vascular abnormalities in young men with persistent side effects after finasteride use for the treatment of androgenic alopecia. Transl Androl Urol. 9(3): 1201-1209.  
• Kohler C, et al. 2007. Effect of finasteride 5mg (Proscar) on acne and alopecia in female patients with normal serum levels of free testosterone. Gynecol Endocrinol. 23:142-145. 
• Kurzrock EA, et al.  2000. Urethral development in the fetal rabbit and induction of hypospadias: a model for human development. J Urol. 164(5):1786-1792. 
• Laborde E, Brannigan RE. 2010. Effect of 1-mg dose of finasteride on spermatogenesis and pregnancy. J Androl. 31(2): e1-2.  
• Lumachi F, Rondinone R. 2003. Use of cyproterone acetate, finasteride, and spironolactone to treat idiopathic hirsutism. Fertil Steril. 79(4):942-946. 
• Martinez AG, et al. 2011. Effects of in utero exposure to D-004, a lipid extract from Roystonea regia fruits, in the male rat: a comparison with finasteride. J Med Food. 14(12):1663-1669.  
• Nabil I, et al. 2024. Protective role of hesperidin in finasteride-induced testicular toxicity in adult male Wistar rats: Insights into oxidative stress, apoptosis, and ultrastructure of seminiferous tubules. Reprod Toxicol.124:108535.  
• Overstreet JW, et al. 1999. Chronic treatment with finasteride daily does not affect spermatogenesis or semen production in young men. J Urol. 162:1295-1300.  
• Paris JJ, et al. 2011. Inhibition of 5 alpha reductase activity in late pregnancy decreases gestational length and fecundity and impairs object memory and central progestogen milieu of juvenile rat offspring. J Neuroendocrinol. 23(11):1079-1090.  
• Prahalada S, et al. 1997. Effects of finasteride, a type 2 5-alpha reductase inhibitor, on fetal development in the Rhesus monkey (Macaca mulatta). Teratology. 55(2):119-131. 
• Propecia prescribing information. 2020. Accessible from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4e07adb4-7807-47d3-b9a9-2332a3047410#S12.3 Accessed June 2026. 
• Ricci G, et al. 2012. Finasteride and fertility: case report and review of the literature. J Drugs Dermatol. 11(12):1511-1513. 
• Rittmaster, RS, 1994. Drug Therapy: Finasteride. New Engl J Med 330(2):120-125.  
• Salvarci A, Istanbulluoglu O. 2013. Secondary infertility due to use of low-dose finasteride. Int Urol Nephrol. 45(1):83-85. 
• Samplaski MK, et al. 2013. Finasteride use in the male infertility population: effects on semen and hormone parameters. Fertil Steril. 100:1528-1529.  
• Santana FFV, et al. 2023. Comparative effects of finasteride and minoxidil on the male reproductive organs: A systematic review of in vitro and in vivo evidence. Toxicol Appl Pharmacol. 478:116710. 
• Spencer JR, et al. 1991. Effects of flutamide and finasteride on rat testicular descent. Endocrinology. 129(2):741-748. 
• Teichert M, et al. 2017. Contraindicated use of 5-alpha-reductase inhibitors in women. Br J Clin Pharmacol. 83(2): 429-431 
• Wise LD, et al. 1991. Reversible decreases of fertility in male Sprague-Dawley rats treated orally with finasteride, a 5-alpha-reductase inhibitor. Reprod Toxicol. 5:353-362.  
• Zeng Y, et al. 2025. Safety concerns of paternal drug exposure on fertility, pregnancy and offspring: An analysis based on the FDA adverse event reporting system. Andrology. 13(6):1420-1431. 

Selected References:

• Ajiji P, et al. 2021. Investigating the efficacy and safety of metronidazole during pregnancy; A systematic review and meta-analysis. Eur J Obstet Gynecol Repr Biol; X,11,100128. 
• Boissiere-O’Neill T, et al. 2026. Exposure to Systemic Antimicrobials During Pregnancy and Risk of Miscarriage: A Population-Based Registry Study. BJOG; 133(7):1394-1404.  
• Burtin P, et al. 1995. Safety of metronidazole in pregnancy: a meta-analysis. Am J Obstet Gynecol; 172(21):525-529.  
• Cantu JM, Garcia-Cruz D. 1982. Midline facial defect as a teratogenic effect of metronidazole. Birth Defects Orig Artic Ser; 18(3 Pt A):85-88.  
• Caro-Paton T, et al. 1997. Is metronidazole teratogenic? A meta-analysis. Br J Clin Pharmacol; 44:(2)179-182.  
• Cram LF, et al. 2015. Genitourinary infections and their association with preterm labor. Am Fam Physician; 65(2), 241–248. 
• Czeizel AE, Rockenbauer M. 1998. A population-based case-control teratologic study of oral metronidazole. Br J Obstet Gynaecol; 105(3):322-327.  
• Diav-Citrin O, et al. 2001. Pregnancy outcome after gestational exposure to metronidazole: a prospective controlled cohort study. Teratology; 63(5):186-192.  
• Einarson A, et al. 2000. Can we use metronidazole during pregnancy and breastfeeding? Putting an end to the controversy. Can Fam Physician; 46:1053-1054. 
• Finegold SM. 1980. Metronidazole. Ann Intern Med; 93:585-587. 
• Flagyl® Prescribing Information. Available online at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020334s015lbl.pdf. Accessed June 2025. 
• Gilbert NM, et al. 2013. Urinary tract infection as a preventable cause of pregnancy complications: Opportunities, challenges, and a global call to action. Glob Adv Health Med; 2(5):59–69.  
• Gray MS, et al. 1961. Further observations on metronidazole (Flagyl). Br J Vener Dis; 37:278-279.  
• Heisterberg L, Branebjerg PE. 1983. Blood and milk concentrations of metronidazole in mothers and infants. J Perinat Med; 11:114-120.  
• Kazy Z, et al. 2005. Teratogenic potential of vaginal metronidazole treatment during pregnancy. Eur J Obstet Gynecol Reprod Biol; 123(2):174-178.  
• Koss CA, et al. 2012. Investigation of Metronidazole Use during Pregnancy and Adverse Birth Outcomes. Antimicrob Agents Chemother; 56(9): 4800-4805.  
• Löfmark S, et al. 2010. Metronidazole is still the drug of choice for treatment of anaerobic infections. Clin Infect Dis; 50(S1):S16–S23.  
• Muanda FT, et al. 2017. Use of antibiotics during pregnancy and risk of spontaneous abortion. CMAJ; 189(17):E625-E633. 
• Nwosu OC, Bloom K. The safety of metronidazole in pregnancy. Health Care Women Int; 2021;42(4-6):726-738.  
• Omranipoor A et al. 2020. Association of antibiotics therapy during pregnancy with spontaneous miscarriage: a systematic review and meta-analysis. Arch Gynecol Obstet; 302(1): 5-22. 
• Passmore CM, et al. 1988. Metronidazole excretion in human breastmilk and its effect on suckling neonates. Br J Clin Pharmacol; 26(1):45-51.  
• Piper JM, et al. 1993. Prenatal use of metronidazole and birth defects: no association. Obstet Gynecol; 82(3):348-352.  
• Rosa FW, et al. 1987. Pregnancy outcomes after first trimester vaginitis drug therapy. Obstet Gynecol; 69(5):751-755.  
• Sheehy O, et al. 2015. The use of metronidazole during pregnancy: a review of evidence. Curr Drug Saf; 10(2):170-179. 
• Workowski KA, Bolan GA. 2015. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep; 64:1-137.