Selected References:  

• Broussard CS, et al. 2011. National Birth Defects Prevention Study. Maternal treatment with opioid analgesics and risk for birth defects. Am J Obstet Gynecol, 204(4):314.e1–e11. 
• Edwards JE, et al. 2003. Hydromorphone transfer into breast milk after intranasal administration. Pharmacotherapy, 23(2):153-158. 
• Fishman B, et al. 2019. Pregnancy outcome following opioid exposure: a cohort study. PLoS One, 14(7):e0219061. 
• Larson JJ, et al. 2019. Cognitive and behavioral impact on children exposed to opioids during pregnancy. Pediatrics, 144(2): e20190514. 
• Lind JN, et al. 2017. Maternal use of opioids during pregnancy and congenital malformations: a systemic review. Pediatrics, 139(6):e20164131. 
• Rhodes Pharmaceuticals L.P. 2021. Hydromorphone hydrochloride product labeling. Available at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=37565441-0d95-4743-a695-d7b3326f58a1.  
• Sinatra RS, et al. 2002. Continuous epidural infusion of 0.05% bupivacaine plus hydromorphone for labor analgesia: an observational assessment in 1830 parturients. Anesth Analg, 94(5):1310-1311. 
• Yazdy MM, et al. 2013. Periconceptional use of opioids and the risk of neural tube defects. ObstetGynecol, 122(4):833-844. 

• Broussard CS, et al. 2011. National Birth Defects Prevention Study. Maternal treatment with opioid analgesics and risk for birth defects. Am J Obstet Gynecol, 204(4):314.e1–e11.
• Edwards JE, et al. 2003. Hydromorphone transfer into breast milk after intranasal administration. Pharmacotherapy, 23(2):153-158.
• Fishman B, et al. 2019. Pregnancy outcome following opioid exposure: a cohort study. PLoS One, 14(7):e0219061.
• Larson JJ, et al. 2019. Cognitive and behavioral impact on children exposed to opioids during pregnancy. Pediatrics, 144(2): e20190514.
• Lind JN, et al. 2017. Maternal use of opioids during pregnancy and congenital malformations: a systemic review. Pediatrics, 139(6):e20164131.
• Rhodes Pharmaceuticals L.P. 2021. Hydromorphone hydrochloride product labeling. Available at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=37565441-0d95-4743-a695-d7b3326f58a1.
• Sinatra RS, et al. 2002. Continuous epidural infusion of 0.05% bupivacaine plus hydromorphone for labor analgesia: an observational assessment in 1830 parturients. Anesth Analg, 94(5):1310-1311.
• Yazdy MM, et al. 2013. Periconceptional use of opioids and the risk of neural tube defects. ObstetGynecol, 122(4):833-844.

Selected References:

• Abdullahi H, et al. 2021. Seasonal influenza during pregnancy. Eur J Obstet Gynecol Reprod Biol. 258:235-239.  
• Anselem O et al. 2019. Improving care for pregnant women with suspected influenza: A retrospective study before and after introduction of a rapid molecular assay. PLoS One. Jun 14;14(6):e0217651 
• Centers for Disease Control and Prevention. 2024. About influenza.  https://www.cdc.gov/flu/about/index.html [Accessed 7/2025]  
• Centers for Disease Control and Prevention. 2024. Preventing seasonal flu.  https://www.cdc.gov/flu/prevention/index.html (Accessed 7/2025) 
• Centers for Disease Control and Prevention. 2023. Influenza (flu) and breastfeeding. https://www.cdc.gov/breastfeeding-special-circumstances/hcp/illnesses-conditions/flu.html [Accessed 7/2025]. 
• Centers for Disease Control and Prevention. 2023Influenza antiviral medications: Summary for clinicians. Available at: https://www.cdc.gov/flu/hcp/antivirals/summary-clinicians.html  
• Dawood FS, et al. 2021. Incidence of influenza during pregnancy and association with pregnancy and perinatal outcomes in three middle-income countries: a multisite prospective longitudinal cohort study. Lancet Infect Dis 21(1):97-106.  
• Dotters-Katz SK. 2024. Influenza in Pregnancy: Maternal, Obstetric, and Fetal Implications, Diagnosis, and Management. Clin Obstet Gynecol. 67(3):557-564 
• Fell DB, et al. 2018. The relationship between 2009 pandemic H1N1 influenza during pregnancy and preterm birth. Epidemiology 29:107-116.  
• Fiore AE, et al. 2010. Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 59(RR-8):1-62. Erratum: Vol. 59, No. RR-8. 
• Grohskoft LA, et al. 2020. Prevention and control of seasonal influenza with vaccines: Recommendations of the Advisory Committee on Immunization Practices-United States, 2020-2021 Influenza Season. MMWR Recomm Rep 69(8):1-24. 
• 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 SE, et al: 2013. Risk of fetal death after pandemic influenza virus infection or vaccination. N Engl J Med 368: 333-340.  
• Legge A, et al. 2014. Rates and determinants of seasonal influenza vaccination in pregnancy and association with neonatal outcomes. CMAJ 186(4): E157-E164.  
• Louie JK, et al. 2015. Pregnancy and severe influenza infection in the 2013-2014 influenza season. Ob Gyn 125(1): 184-192. 
• Luteijn JM, Brown MJ, Dolk H. 2014. Influenza and congenital anomalies: a systematic review and meta-analysis. Hum Reprod. 29(4):809-23. 
• Mátrai Á, et al. 2022. First-Trimester Influenza Infection Increases the Odds of Non-Chromosomal Birth Defects: A Systematic Review and Meta-Analysis. Viruses. 2022 Dec 2;14(12):2708.  
• Mátrai Á, et al 2023. Reducing the Risk of Birth Defects Associated with Maternal Influenza: Insights from a Hungarian Case-Control Study. J Clin Med. 12(21):6934.  
• Memoli MJ, et al. 2013. Influenza in pregnancy. Influenza Other Respir Viruses. 7(6):1033-9.  Neuzil KM, et al. 1998. Impact of influenza on acute cardiopulmonary hospitalizations in pregnant women. Am J Epidemiol. 148(11):1094-1102.  
• Nypaver C, et al. 2021. Influenza and Influenza Vaccine: A Review. J Midwifery Womens Health. 66(1):45-53. PMID: 33522695. 
• Oseghale O, et al. 2022. Influenza Virus Infection during Pregnancy as a Trigger of Acute and Chronic Complications. Viruses. 14(12): 2729. 
• Payne K, et al. 2020. Twenty-First Century Viral Pandemics: A Literature Review of Sexual Transmission and Fertility Implications in Men. Sex Med Rev 8(4):518-530. 
• Selten JP,et al. 2017. The serological evidence for maternal influenza as risk factor for psychosis in offspring is insufficient: critical review and meta-analysis. Schizophr Res 183:2-9. 
• Tamma PD, et al. 2009. Safety of influenza vaccination during pregnancy. Am J Obstet Gynecol. 201(6):547-52. 
• Zerbo O, et al. 2017. Association between influenza infection and vaccination during pregnancy and risk of autism spectrum disorder. JAMA Pediatr 171(1):e163609. 

Selected References:

• Bazzani C, et al. 2015. Prospectively-followed pregnancies in patients with inflammatory arthritis taking biological drugs: an Italian multicentre study. Clin Exp Rheumatol, 33(5):688-693. 
• Beltagy A, et al. 2021. Biologics During Pregnancy and Breastfeeding Among Women With Rheumatic Diseases: Safety Clinical Evidence on the Road. Frontiers in pharmacology vol. 12 621247. 
• Berthelsen BG, et al. 2010. Etanercept concentrations in maternal serum, umbilical cord serum, breast milk and child serum during breastfeeding. Rheumatology (Oxford), 49:2225-2227. 
• Bertrand K, et al. 2023. The Concentration of Etanercept in Human Milk and Infant Outcomes. The Journal of rheumatology vol 50: 712-714. 
• Brӧms G, et al. 2016. Low risk of birth defects for infants whose mothers are treated with anti-tumor necrosis factor agents during pregnancy. Clinical Gastroenterology and Hepatology, 14(2):234-241.e5. 
• Carman WJ, et al. 2017. Pregnancy and infant outcomes including major congenital malformations among women with chronic inflammatory arthritis or psoriasis, with and without etanercept use. Pharmacoepidemiol Drug Saf, 26:1109-1118. 
• Carter JD, et al. 2009. A safety assessment of tumor necrosis factor antagonists during pregnancy: A review of the Food and Drug Administration Database. The Journal of Rheumatology, 36:3. 
• Carter JD, et al. 2006. Tumor necrosis factor-alpha inhibition and VATER association: a causal relationship. J Rheumatol, 33(5):1014-1017. 
• Chambers CD, et al. 2004. Pregnancy outcome in women exposed to anti-TNF-alpha medications:  The OTIS Rheumatoid Arthritis in Pregnancy Study [abstract]. Arthritis Rheum, 50(9):S479-S480. 
• Chambers CD, et al. 2015. Pregnancy outcomes in women exposed to etanercept: the OTIS autoimmune diseases in pregnancy project. Abstract presented at Annual Meeting, Am College of Rheum, San Francisco, CA. 
• Clark, DA. 2010.  Anti-TNF_ therapy in immune-mediated subfertility: State of the art. J Reprod Immunol, 85(1):15-24. 
• Dall’ara F, et al. 2016. Safety of anti-TNF alfa agents during pregnancy and breastfeeding: longterm follow up of exposed children in a case-series of mothers with chronic arthritides. Ann Rheum Dis, 75(Suppl 2): 493. 
• Dai F, et al. 2022. TNF-a/anti-TNF-a drugs and its effect on pregnancy outcomes. Expert reviews in molecular medicine vol 24 e26. 
• Dernoncourt A, et al. 2023. Fetal and Neonatal Adverse Drug Reactions Associated with Biologics Taken During Pregnancy by Women with Autoimmune Diseases: Insights from an Analysis of the World Health Organization Pharmacovigilance Database. VigiBase. BioDrugs: clinical immunotherapeutics, biopharmaceuticals and gene therapy vol 31: 73-87. 
• Diav-Citrin O, et al. 2014. Pregnancy outcome following gestational exposure to TNF-alpha-inhibitors: A prospective, comparative, observational study. Reprod Toxicol, 43:78-84. 
• Food and Drug Administration 2012. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103795s5503lbl.pdf [Accessed 7/2023]. 
• Johnson DL, et al. 2008. Pregnancy outcomes in women exposed to etanercept: The OTIS Autoimmune Diseases in Pregnancy Project [abstract]. Arthritis and Rheumatism, 58(9):S682.  
• Keeling S and Wolbink GJ. 2010. Measuring multiple etanercept levels in the breast milk of a nursing mother with rheumatoid arthritis. J Rheumatol, 37(7):1551. 
• Membrive-Jiménez C, et al. 2003. Safety and effectiveness of bDMARDs during pregnancy in patients with rheumatic diseases: Real-world data from the BIOBADASER registry. Reumatol Clin (Engl Ed) 
• Micu MC, et al. 2014. TNF-alpha inhibitors do not impair sperm quality in males with ankylosing spondylitis after short-term or long-term treatment. Rheumatology (Oxford), 53(7):1250-1255.  
• Ӧnalan G, et al. 2018. Effect of etanercept on the success of assisted reproductive technology in patients with endometrioma. Gynecol Obstet Invest, 83(4):358-364. 
• Orozco C, et al. 2005. Safety of TNF inhibitors during pregnancy in patients with inflammatory arthritis. Abstract presented at 69th Annual Meeting, Am College of Rheum, San Diego, CA, November 13th-17th. 
• Pentsuk N and van der Laan JW. 2009. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol, 86(4):328-344. 
• Romanowska-Prochnicka K et al. 2021. The Role of TNF-a and Anti-TNF-a Agents during Preconception, Pregnancy, and Breastfeeding. International jourinal of mokecular sciences vol.22, 6 2922. 
• Roux CH, et al. 2006. Pregnancy in rheumatology patients exposed to anti-tumour necrosis factor (TNF)-{alpha} therapy. Rheumatology, 46: 695-698. 
• Rüegg L, et al. 2025. EULAR recommendations for use of antirheumatic drugs in reproduction, pregnancy, and lactation: 2024 update. Ann Rheum Dis. 2025 Jun;84(6):910-926.  
• Russell M, et al. 2023. British Society for Rheumatology guideline on prescribing drug in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids. Rheumatology vol 62.: e48-e88. 
• Verstappen SM, et al. 2011. BSRBR Control Centre Consortium, BSR Biologics Register. Concise report: anti-TNF therapies and pregnancy: outcome of 130 pregnancies in the British Society for Rheumatology Biologics Register. Ann Rheum Dis, 70(5): 823-826.  
• Villiger PM, et al. 2010. Effects of TNF antagonists on sperm characteristics in patients with spondyloarthritis. Ann Rheum Dis, 69(10): 1842-1844. 
• Viktil KK, et al. 2012. Outcomes after anti-rheumatic drug use before and during pregnancy: a cohort study among 150 000 pregnant women and expectant fathers. Scandinavian Journal of Rheumatology, 41(3): 196-201. 
• Vinet E, et al. 2018. Serious infections in rheumatoid arthritis offspring exposed to tumour necrosis factor alpha inhibitors: A cohort study. Arthr Rheumatol, 70(10):1565-1571. 
• Weber-Schoendorfer C, et al. 2015. Pregnancy outcome after TNF-alpha inhibitor therapy during the first trimester: a prospective multicentre cohort study. Br J Clin Pharmacol, 80(4): 727-739. 

Selected References:

• Anderson PO. 2021. Monoclonal antibodies during breastfeeding. Breastfeeding Med.16(8):591-593.  
• Bellot M, et al. 2022. Effect of ofatumumab on pregnancy, parturition, and lactation in cynomolgus monkeys. Reprod Toxicol. 108:28-34.  
• Ciplea A, et al. 2023. Ofatumumab in breast milk of multiple sclerosis patients. Mult Scler J. ;29 (3_Suppl):132-3.  
• Dobson R, et al. 2023. Anti-CD20 therapies in pregnancy and breast feeding: a review and ABN guidelines. Pract Neurol. 23(1):6-14. . 
• Gklinos P, Dobson R. 2023. Monoclonal Antibodies in Pregnancy and Breastfeeding in Patients with Multiple Sclerosis: A Review and an Updated Clinical Guide. Pharmaceuticals (Basel). 16(5):770. doi: 10.3390/ph16050770. PMID: 37242553; PMCID: PMC10223026. 
• Hauser SL, et al. 2022. Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years. Mult Scler. 2022 Sep;28(10):1576-1590.  
• Hefner S, et al. 2025. Impact of continuous ofatumumab exposure during pregnancy in multiple sclerosis. Neurol Clin Pract 15(1): e200410.  
• Hellwig K, et al. 2022. Pregnancy outcomes in patients with multiple sclerosis following exposure to ofatumumab (P4-4.007). Neurology. Neurology, 98 (18 Supplement) 3377.  
• Krajnc N, et al. 2022. Monoclonal Antibodies in the Treatment of Relapsing Multiple Sclerosis: an Overview with Emphasis on Pregnancy, Vaccination, and Risk Management. Neurotherapeutics. 19(3):753-773.  
• Krysko KM, et al. 2023. Family planning considerations in people with multiple sclerosis. Lancet Neurol. 22(4):350-366.  
• Novartis Pharmaceuticals Corporation. 2022. Kesimpta® (ofatumumab) Prescribing Information. Available online at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6a8a3f53-2062-48ff-9dbe-b939df133ca3&audience=consumer  
• Novartis Pharmaceuticals Corporation. 2022. Arzerra® (ofatumumab) Prescribing Information. Available online at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=77785ce3-e8df-4ca1-8f8e-6c418c6a17de&audience=consumer  
• Quattrocchi E, Ostergaard M, Taylor PC, van Vollenhoven RF, Chu M, Mallett S, Perry H, Kurrasch R. 2016. Safety of repeated open-label treatment courses of intravenous ofatumumab, a human anti-cd20 monoclonal antibody, in rheumatoid arthritis: Results from three clinical trials. PLoS One. Jun 23;11(6): e0157961.  
• Schwake C, et al.2022. Effects of anti-CD20 therapies on infant health and physiological B-cell development if administered before or during pregnancy and/or lactation. Mult Scler J.  28 (3 Suppl):29-30.  
• Witt L, et al. 2025. Ofatumumab-exposed breastfeeding in multiple sclerosis patients. Mult Scler. 31(3):338-351.  

Selected References:

• Arendt KW, et al. 2011. Topical vasoconstrictor use for nasal intubation during pregnancy complicated by cardiomyopathy and preeclampsia. Int J Obstet Anesth. 20(3):246-9.
• Aselton P, et al. 1985. First-trimester drug use and congenital disorders. Obstet Gynecol 65:451-455, 1985.
• Baxi LV, et al. 1985. Fetal heart rate changes following maternal administration of a nasal decongestant. Am J Obstet Gynecol. 153:799-800.
• Jick H, et al. 1981. First-trimester drug use and congenital disorders. JAMA 246:343-346.
• Mazzotta P, et al. 1999. Treating allergic rhinitis in pregnancy. Safety considerations. Drug Saf. 20(4):361-75.
• Menezes GA, et al. 2016. Prenatal diagnosis and physical model reconstruction of agnathia-otocephaly with limb deformities (absent ulna, fibula and digits) following maternal exposure to oxymetazoline in the first trimester. J Obstet Gynaecol Res. 42(8):1016-20.
• Rayburn WF, et al. 1990. Uterine and fetal Doppler flow changes from a single dose of a long-acting intranasal decongestant. Obstet Gynecol. 76:180-2.
• Yau W-P, et al. 2013. Use of decongestants during pregnancy and the risk of birth defects. Am J Epidemiol. 178(2):198-208.