
Hydroxychloroquine
Selected References:
- Andersson NK, et al. 2021. Fetal safety of chloroquine and hydroxychloroquine use during pregnancy: a nationwide cohort study. Rheumatology (Oxford). 14;60(5):2317-2326.
- Bérard A, et al. 2021. Chloroquine and hydroxychloroquine use during pregnancy and the risk of adverse pregnancy outcomes using real-world evidence. Front Pharmacol. 12:722511.
- Berman A, et al. 2025. Hydroxychloroquine and pregnancy outcomes in patients with anti-phospholipid syndrome: a systematic review and meta-analysis. RMD Open. 11(3):e005825.
- Bermas BL, et al. 2018. Trends in use of hydroxychloroquine during pregnancy in systemic lupus erythematosus patients from 2001 to 2015. Lupus. 27(6):1012-1017.
- Buchanan NM, et al. 1996. Hydroxychloroquine and lupus pregnancy: review of a series of 36 cases. Ann Rheum Dis. 55(7):486-488.
- Centers for Disease Control and Prevention (CDC). 2024. Malaria. Available at URL: https://www.cdc.gov/malaria/index.html [Accessed April 2026]
- Centers for Disease Control and Prevention (CDC). 2024. Treatment of Malaria: Guidelines for Clinicians (United States): Alternatives for Pregnant Women. Available at URL: https://www.cdc.gov/malaria/hcp/clinical-guidance/pregnant-women.html [Accessed April 2026]
- Chambers CD, et al. 2022. Birth outcomes in women who have taken hydroxychloroquine during pregnancy: a prospective cohort study. Arthritis Rheumatol. 74(4):711-724.
- Cimaz R, et al. 2004. Electroretinograms of children born to mothers treated with hydroxychloroquine during pregnancy and breast-feeding: comment on the article by Costedoat-Chalumeau et al. Arthritis Rheum. 50(9):3056-3057.
- Clowse MEB, et al. 2006. Hydroxychloroquine in lupus pregnancy. Arthritis Rheum. 54(11):3640-3647.
- Costedoat-Chalumeau N, et al. 2003. Safety of hydroxychloroquine in pregnant patients with connective tissue diseases: a study of one hundred thirty-three cases compared with a control group. Arthritis Rheum. 48(11):3207-3211.
- Diav-Citrin O, et al. 2013. Pregnancy outcome following in utero exposure to hydroxychloroquine: a prospective comparative observational study. Reprod Toxicol. 39:58-62.
- Feldkamp M, Carey JC. 1993. Clinical teratology counseling and consultation case report: low dose methotrexate exposure in the early weeks of pregnancy. Teratology. 47(6):533-539.
- Flint J, et al. 2016. BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 55(9):1693-1697.
- Frassi M, et al. 2004. Hydroxychloroquine in pregnant patients with rheumatic disease: a case control observation of 76 treated pregnancies. Lupus 13(9):755.
- Howley MM, et al. 2021. Maternal exposure to hydroxychloroquine and birth defects. Birth Defects Res 113(17):1245-1256.
- Huybrechts KF, et al. 2021. Hydroxychloroquine early in pregnancy and risk of birth defects. Am J Obstet Gynecol. 224(3):290.e1-290.e22.
- Ingster-Moati I, Albuisson E. 2010. Visual neurophysiological dysfunction in infants exposed to hydroxychloroquine in utero. Acta Paediatr. 99(1):4; author reply 4-5.
- Kaplan YC, et al. 2016. Reproductive outcomes following hydroxychloroquine use for autoimmune diseases: a systematic review and meta-analysis. Br J Clin Pharmacol. 81(5):835-848.
- Kroese SJ, et al. 2017. Hydroxychloroquine use in lupus patients during pregnancy is associated with longer pregnancy duration in preterm births. J Immunol Res. 2017:2810202. Levy RA, et al. 2001. Hydroxychloroquine (HCQ) in lupus
- pregnancy: double-blind and placebo-controlled study. Lupus. 10(6):401-404.
- Mairesse R, et al. 2026. In utero exposure to medications and congenital eye anomalies. BMJ Open Ophthalmol. 11(1):e002049. Available: https://pmc.ncbi.nlm.nih.gov/articles/PMC12778234/pdf/bmjophth-11-1.pdf [Accessed April 2026]
- Mirzaei M, et al. 2023. The effects of hydroxychloroquine on pregnancy outcomes in infertile women: a systematic review and meta-analysis. J Med Life. 16(2):189-194.
- Mouyis M, et al. 2019. Safety of anti-rheumatic drugs in men trying to conceive: a systematic review and analysis of published evidence. Semin Arthritis Rheum. 48(5): 911-920.
- National Institutes of Health. 2021. Product label: hydroxychloroquine sulfate tablet. Available at URL: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=84b00366-96ef-41e1-bac6-5d24acdb9e1d. [Accessed April 2026]
- Rüegg L, et al. 2025. EULAR recommendations for use of antirheumatic drugs in reproduction, pregnancy, and lactation: 2024 update. Ann Rheum Dis. 84(6):910-926.
- Sammaritano LR, et al. 2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. Arthritis Rheumatol. 72(4):529-556.
- Silver R, et al. 2023. Society for Maternal-Fetal Medicine Consult Series #64: Systemic lupus erythematosus in pregnancy. Am J Obstet Gynecol. 228(3):B41-B60.
- Sperber K, et al. 2009. Systematic review of hydroxychloroquine use in pregnant patients with autoimmune diseases. Pediatr Rheumatol Online J. 13:7:9.
- Tian Y, et al. 2021. The additional use of hydroxychloroquine can improve the live birth rate in pregnant women with persistent positive antiphospholipid antibodies: A systematic review and meta-analysis. J Gynecol Obstet Hum Reprod. 50(8):102121.
- Ye S, et al. 2023. The use of hydroxychloroquine in pregnancy and its effect on perinatal outcomes in a population with autoimmune abnormalities. Clin Rheumatol. 42(4):1137-1150.
- Zhu Q, et al. 2024. Effect of hydroxychloroquine on pregnancy outcome in patients with SLE: a systematic review and meta-analysis. Lupus Sci Med. 11(2):e001239.
Hydroxychloroquine
Selected References:
Hydroxychloroquine
Selected References:
- Bourg M, et al. 2020. Fertility and sexuality of women with inflammatory arthritis. European Journal of Obstetrics & Gynecology and Reproductive Biology, 251:199-205.
- Giovannopoulou E, et al. 2017. Ankylosing Spondylitis and Pregnancy: A Literature Review. Curr Rheumatol Rev. 13(3):162-169.
- Girbash E, et al. 2023. Maternal Interleukin-17 and disease activity influence pregnancy outcomes in women with psoriatic arthritis. BMC Pregnancy Childbirth. 23(1):35.
- Gordon D, Beastall GH, Thomson JA, et al. 1986 Androgenic status and sexual function in males with rheumatoid arthritis and ankylosing spondylitis. Q J Med; 60(231): 671–679.
- Jakobsson GL, et al. 2016. Pregnancy outcomes in patients with ankylosing spondylitis: a nationwide register study. Ann Rheum Dis. 75(10):1838-42.
- Lee JS, et all. 2020. Reasons for the High Cesarean Delivery Rate among Women with Ankylosing Spondylitis: Using the Korean National Health Insurance Database. The Journal of Rheumatology, 47(5) 668-673.
- Lui NL, et al. 2011. Effect of pregnancy on ankylosing spondylitis: a case-control study. J Rheumatol 38(11):2442-4.
- Maguire S, et al. 2020. Pregnancy in axial spondyloarthropathy–A systematic review & meta-analysis. Semin Arthritis Rheum; 50(6):1269-1279.
- Maguire S, et al. 2022. What to expect when women with axial spondyloarthritis are expecting: Prevalence of complications of pregnancies in women with axial spondyloarthritis. Semin Arthritis Rheum; 54:151993.
- Menekse Beser D, et al. 2023. Assessment of fetal pulmonary artery Doppler indices in pregnant women with rheumatoid arthritis and ankylosing spondylitis. J Clin Ultrasound. 51(6):983-991.
- Mokbel A, et al. 2021. Pregnancy outcomes in women with ankylosing spondylitis: a scoping literature and methodological review. Clin Rheumatol; 40(9):3465-3480.
- Mørk S, et al. 2021. Spondyloarthritis and outcomes in pregnancy and labor–A nationwide register-based cohort study. Arthritis Care Res, 73(2), 282-288.
- Ostensen M. 1992. The effect of pregnancy on ankylosing spondylitis, psoriatic arthritis, and juvenile rheumatoid arthritis. Am J Reprod Immunol. 28(3-4):235-7.
- Ostensen M & Husby G. 1989. Ankylosing spondylitis and pregnancy. Rheum Dis Clin North Am. 15(2):241-54.
- Ostensen M & Ostensen H. 1998. Ankylosing spondylitis–the female aspect. J Rheumatol. 25(1):120-4.
- Ostensen M, et al. 2004. A prospective study of pregnant patients with rheumatoid arthritis and ankylosing spondylitis using validated clinical instruments. Ann Rheum Dis. 63(10):1212-7.
- Ramonda R, Foresta C, Ortolan A, et al. 2014. Influence of tumor necrosis factor α inhibitors on testicular function and semen in spondyloarthritis patients. Fertil Steril. 101(2): 359–365.
- Saougou I1, Markatseli TE, Papagoras C, et al. 2013. Fertility in male patients with seronegative spondyloarthropathies treated with infliximab. Joint Bone Spine; 80(1): 34–37.
- Scriffignano S, et al. 2024. Male Fertility in Spondyloarthritis: from Clinical Issues to Cytokines Milieu. A Narrative Review. Curr Rheumatol Rep. doi: 10.1007/s11926-024-01153-w.
- Smith CJF, et al. 2020. Birth Outcomes and Disease Activity During Pregnancy in a Prospective Cohort of Women With Psoriatic Arthritis and Ankylosing Spondylitis. Arthritis Care Res, 72:1029-1037.
- Unal C, et al. 2020. Retrospective evaluation of pregnancies with ankylosing spondylitis in a tertiary center in Turkey. Int J Rheum Dis. 23:101-105.
- Uyaroglu OA, Seyhoglu E, Erden A, et al. 2020. Pregnancy outcomes in partners of male ankylosing spondylitis patients treated with anti-tumour necrosis factor-α biologics: real-life results from a single-centre cross-sectional study. Rheumatol Int.;40(9):1501-1507.
- Yildirim M, et al. 2023. Assessment of fetal thymus size in pregnant women with rheumatic diseases: A case-control study. J Clin Ultrasound. 51(8): 1342-1347.
Hydroxychloroquine
Selected References:
- Deepaklal MC, et al. 2015. Insulin aspart in patients with gestational diabetes mellitus and pregestational diabetes mellitus. Indian J Endocrinol Metab; 19(5): 658–662.
- Hod M, et al. 2008. Fetal and perinatal outcomes in type 1 diabetes pregnancy: a randomized study comparing insulin aspart with human insulin in 322 subjects. Am J Obstet Gynecol’ 198(2)186.e1-7.
- Matheisen ER, et al. 2007. Maternal glycaemic control and hypoglycaemia in Type 1 diabetes pregnancy: a randomized trial of insulin aspart vs. human insulin in 322 pregnant women. Diabetes Care; 30(4):771-776.
- Mathiesen ER, et al. 2008. Insulin Aspart in Diabetic Pregnancy: State of the Art. Women’s Health 4(2):119-124.
- Mathiesen ER, et al; EVOLVE study group. 2024. A comparison of the safety and effectiveness of insulin aspart with other bolus insulins in women with pre-existing Type 1 diabetes during pregnancy: A post hoc analysis of a prospective cohort study. Diabet Med; 41(10):e15411.
- Insulin Aspart Product Label. 2023. National Institute of Health DailyMed database. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bee5b358-c863-420b-be73-ced2e920c499. Accessed 3/2026.
- Pettitt DJ, et al. 2007. Efficacy, safety and lack of immunogenicity of insulin aspart compared with regular human insulin for women with gestational diabetes mellitus. Diabet Med; 24(10): 1129–1135.
- Shehadeh N, et al. 2001. Importance of insulin content in infant diet: suggestion for a new infant formula. Acta Paediatr; 90(1):93-95.
- Shehadeh N, et al. 2001. Insulin in human milk and the prevention of type 1 diabetes. Pediatr Diabetes; 2(4):175-177.
- Whitmore TJ, et al. 2012. Analysis of Insulin in Human Breast Milk in Mothers with Type 1 and Type 2 Diabetes Mellitus. Int J Endocrinol. vol. 2012: Article ID 296368.
Hydroxychloroquine
Selected References:
- Abdellatif M, et al. 2019. Association between exposure to macrolides and the development of infantile hypertrophic pyloric stenosis: a systematic review and meta-analysis. Eur J Pediatr. 178:301–314.
- Antonucci R, et al. 2022. Use of Azithromycin in Pregnancy: More Doubts than Certainties. Clinical drug invest. 42(11): 921–935.
- Bakheit, AH, et al. 2014. Azithromycin. Profiles of Drug Substn, Excip, and Rel Methodol. 39:1-40.
- Bérard A et al. 2015. Use of macrolides during pregnancy and the risk of birth defects: a population-based study. Pharmacoepidemiol Drug Saf 24(12):1241–1248.
- Cooper WO, et al. 2002. Prenatal prescription of macrolide antibiotics and infantile hypertrophic pyloric stenosis. Obstet Gynecol; 100:101–106.
- Cooper WO, et al. 2009. Antibiotics potentially used in response to bioterrorism and the risk of major congenital malformations. Paediatr Perinat Epidemiol. 23(1):18-28.
- Damkier P, et al. 2019. In utero exposure to antibiotics and risk of congenital malformations: a population-based study. Am J Obstet Gynecol 221(6):648.e1–648.e15.
- Fan H, et al. 2020. Associations between macrolide antibiotics prescribing during pregnancy and adverse child outcomes in the UKL Population based cohort study. BMJ 368:m331.
- Figueroa-Romero A, et al. 2022. Drugs for intermittent preventive treatment of malaria in pregnancy: current knowledge and way forward. Trop. Med. Infect. Dis. 8(7): 152.
- Goldstein LH, et al. 2009. The safety of macrolides during lactation. Breastfeed Med, 4(4):197-200.
- Heikkinen T., et al. 2005. The transplacental transfer of the macrolide antibiotics erythromycin, roxithromycin and azithromycin. BJOG: An Intern Jour of Obstet and Gynaecol. 107(6):770-775.
- Hume-Nixon M, et al. 2021. A systematic review and meta-analysis of the effect of administration of azithromycin during pregnancy on perinatal and neonatal outcomes. EClinicalMedicine 40:101123.
- Leke, AZ, et al. 2021. Macrolide and lincosamide antibiotic exposure in the first trimester of pregnancy and risk of congenital anomaly: A European case-control study. Reprod Toxicol 100:101–108.
- Lund M, et al. 2014. Use of macrolides in mother and child and risk of infantile hypertrophic pyloric stenosis: nationwide cohort study. BMJ. 348:g1908.
- Mårdh PA. 2002. Influence of infection with chlamydia trachomatis on pregnancy outcome, infant health and life-long sequelae in infected offspring. Best Pract and Research Clin Obstet and Gynaec. 16(6): 847-864.
- Muanda FT, et al. 2017. Use of antibiotics during pregnancy and risk of spontaneous abortion. CMAJ. 189(17):625-633.
- Pfizer Labs. 2021. Zithromax (azithromycin) label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050670s036,050710s051,050711s050,050784s037lbl.pdf. Accessed 4 Nov 2025.
- Rahangdale L, et al. 2006. An observational cohort study of Chlamydia trachomatis treatment in pregnancy. Sex Transm Dis. 33(2):106-110.
- Sandman Z., Iqbal OA. 2024. Azithromycin. StatPearls. Available at: https://www.ncbi.nlm.nih.gov/books/NBK557766/. Accessed 4 Nov 2025.
- Sarkar M, et al. 2006. Pregnancy outcome following gestational exposure to azithromycin. BMC Pregnancy Childbirth. 6:18.
- Sørensen HT, et al. 2003. Risk of infantile hypertrophic pyloric stenosis after maternal postnatal use of macrolides. Scand J Infect Dis. 35(2):104-106.
- Sutton A, et al. 2014. Azithromycin accumulates in breast milk following a single dose for cesarean prophylaxis. AJOG. 210(1):S235.
- Tellem R, et al. 2005. Pregnancy outcome after gestational exposure to the new macrolides: a prospective controlled cohort study. Reprod Toxicol.;20(3):484-485.
- U.S. Centers for Disease Control and prevention. 2021. Chlamydia Infections – STI Treatment Guidelines. Available at: https://www.cdc.gov/std/treatment-guidelines/chlamydia.htm. Accessed 4 Nov 2025.
- Wilton LV, et al. 1998. The outcomes of pregnancy in women exposed to newly marketed drugs in general practice in England. Br J Obstet Gynaecol. 105(8): 882–889.