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.

Selected References:

• Bryant Ranch Prepack. 2024. Hydroxyzine Hydrochloride Product Label. Available at: https://www.accessdata.fda.gov/spl/data/897a39b6-65b1-4e52-85e9-2650d23a4dc0/897a39b6-65b1-4e52-85e9-2650d23a4dc0.xml. Accessed 14 April 2025.
• Calderon-Margalit, R., Qiu, C., Ornoy, A., Siscovick, D. S., & Williams, M. A. 2009. Risk of preterm delivery and other adverse perinatal outcomes in relation to maternal use of psychotropic medications during pregnancy. American journal of obstetrics and gynecology, 201(6), 579.e1–579.e5798.
• Diav-Citrin O, et al. 2003. Pregnancy outcome after gestational exposure to loratidine or antihistamines: a prospective controlled cohort study. J Allergy Clin Immunol 111:1239-1243.
• Earl FL, et al. 1973. Teratogenic research in beagle dogs and miniature swine. Lab Anim Drug Test Symp Int Comm Lab Anim, 5th Fischer, Stuttgart pp. 233-247.
• Einarson A, et al. 1997. Prospective controlled study of hydroxyzine and cetirizine in pregnancy. Ann Allergy Asthma Immunol 78:183-186.
• Erez S, et al. 1971. Double-blind evaluation of hydroxyzine as an antiemetic in pregnancy. J Reprod Med 7:57-59.
• Ito S, et al. 1993. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol 168:1393-1399.

Selected References:

• Andersen JT, et al. 2016. Diclofenac/misoprostol during early pregnancy and the risk of miscarriage: a Danish nationwide cohort study. Arch Gynecol Obstet 294(2): 245-250.
• Cassina M, et al. 2010. First trimester diclofenac exposure and pregnancy outcome. Reprod Toxicol 30:401-404.
• Choi E-Y, et al. 2023. Neonatal and maternal adverse outcomes and exposure to nonsteroidal anti-inflammatory drugs during early pregnancy in South Korea: a nationwide cohort study. PLoS Med, 20(2):e1004183.
• Dawood MY. 1993. Nonsteroidal anti-inflammatory drugs and reproduction. Am J Obstet Gynecol, 169(5):1255-1265.
• Daniel S, et al. 2012. Major malformations following exposure to Nonsteroidal anti-inflammatory drugs during the first trimester of pregnancy. J Rheumatol 39(11): 2163-2169.
• Daniel S, et al. 2014. Fetal exposure to nonsteroidal anti-inflammatory drugs and spontaneous abortion. Can Med Assoc J 186(5):E177-E182.
• Daniel S, et al. 2015. NSAIDs and spontaneous abortions – true effect or an indication bias? Br J Clin Pharmacol, 80(4):750-754.
• Dathe K, et al. 2018. No evidence of adverse pregnancy outcome after exposure to ibuprofen in the first trimester—Evaluation of the national Embryotox cohort. Reproductive Toxicology, 79: 32-38.
• Ericson A and Kallen BA. 2001. Nonsteroidal anti-inflammatory drugs in early pregnancy. Reprod Toxicol, 15:371-
• Janssen NM and Genta MS. 2000. The effects of immunosuppressive and anti-inflammatory medication on fertility, pregnancy, and lactation. Arch Intern Med, 160:610-619.
• Nakhai-Pour HR, et al. 2011. Use of nonaspirin nonsteroidal anti-inflammatory drugs during pregnancy and the risk of spontaneous abortion. CMAJ. 183(15):1713-1720.
• Nezvalova-Henriksen K et al. 2013. Effects of ibuprofen, diclofenac, naproxen, and piroxicam on the course of pregnancy and pregnancy outcome: a prospective study. BJOG, 120(8):948-959.
• Nielsen GL, et al. 2001. Risk of adverse birth outcome and miscarriage in pregnant users of non-steroidal anti-inflammatory drugs: population based observational study and case-control study. BMJ, 322(7281):266-270.
• Nielsen GL, et al. 2004. Danish group reanalyses miscarriage in NSAID users. BMJ, 328(7431):109.
• Ofori B, et al. 2006. Risk of congenital anomalies in pregnant users of non-steroidal anti-inflammatory drugs: a nested case-control study. Birth Defects Res B Dev Reprod Toxicol 77:268-279.
• Padberg S, et al. 2018. Safety of diclofenac use during early pregnancy: A prospective observational cohort study. Reprod Toxicol. 77:122-129.
• Phadke V, et al. 2012. Maternal ingestion of diclofenac leading to renal failure in newborns. Pediatr Nephrol. 27(6):1033-1036.
• S. Food and Drug Administration. 2020. FDA Warns that Using a Type of Pain and Fever Medication in Second Half of Pregnancy Could Lead to Complications.Available at: https://www.fda.gov/news-events/press-announcements/fda-warns-using-type-pain-and-fever-medication-second-half-pregnancy-could-lead-complications?utm_medium=email&utm_source=govdelivery Accessed 2 Dec 2024.
• Scherneck S, et al. 2015. Reversible oligohydramnios in the second trimester of pregnancy in two patients with long-term diclofenac exposure. Reprod Toxicol. 58:61-64.