Selected References:

• Babuna Kobaner G, Polat Ekinci A. 2020. Infliximab for the treatment of recalcitrant generalized pustular psoriasis of pregnancy: Report of a challenging case. Dermatologic Therapy. 33(4): e13571
• Bendaoud, S, et al. 2024. Risk of anti-TNF therapy on pregnancy, breastfeeding, live vaccines and related information in patients with inflammatory bowel disease: Real-world data from a nationwide study. Digestive and liver disease: official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, 56(12), 2038–2044.
• Bröms G, et al. 2020. Anti-TNF treatment during pregnancy and birth outcomes: A population-based study from Denmark, Finland, and Sweden. Pharmacoepidemiol Drug Saf. 29(3):316-327.
• Beaulieu DB, et al. 2018. Use of biologic therapy by pregnant women with inflammatory bowel disease does not affect infant response to vaccines. Clin Gastroenterol Hepatol. 16:99-105.Carter JD, et al. 2009. A safety assessment of tumor necrosis factor antagonists during pregnancy: a review of the Food and Drug Administration database. J Rheumatol. 36(3):635-41. Chaparro M, Gisbet JP. 2014. How safe is infliximab therapy during pregnancy and lactation in inflammatory bowel disease. Expert Opin Drug Saf. 13(12):1749-62.
• 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. 37(1):73-87.
• Geldhof A, et al. 2020. Exposure to infliximab during pregnancy: Post-marketing experience. Drug Saf. 43(2):147-161.
• Goulden B, et al. 2022. A systematic review of live vaccine outcomes in infants exposed to biologic disease modifying anti-rheumatic drugs in utero. Rheumatology (Oxford). 6;61(10):3902-3906.
• Grgić, D., et al. 2020. Pregnancy-onset acute severe colitis after in vitro fertilization embryo transfer. Case reports in gastroenterology. 14(3):477–482.
• Heller MM, et al. 2011. Fatal case of disseminated BCG infection after vaccination of an infant with in utero exposure to infliximab. J Am Acad Dermatol. 65(4):870.
• Kanis SL, et al. 2021. Health outcomes of 1000 children born to mothers with inflammatory bowel disease in their first 5 years of life. Gut. 70(7):1266-1274.
• Kimberlin, D, et al. 2021. “Rotavirus Infections”, Red Book: 2021–2024 Report of the Committee on Infectious Diseases, Committee on Infectious Diseases, American Academy of Pediatrics.
• Mahadevan U, et al. 2013. Placental transfer of anti-tumor necrosis factor agents in pregnant patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 11(3):286-92.
• Mahadevan U, et al. 2021. Pregnancy and neonatal outcomes after fetal exposure to biologics and thiopurines among women with inflammatory bowel disease. Gastroenterology. 160(4):1131-1139.
• Meserve J, et al. 2021. Paternal exposure to immunosuppressive and/or biologic agents and birth outcomes in patients with immune-mediated inflammatory diseases. Gastroenterology. 161(1):107-115.e3.
• Micu MC, et al. 2014. TNF-α inhibitors do not impair sperm quality in males with ankylosing spondylitis after short-term or long-term treatment. Rheumatology (Oxford). 53(7):1250-5.
• 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.
• Saougou I, et al. 2013. Fertility in male patients with seronegative spondyloarthropathies treated with infliximab. Joint Bone Spine. 80(1):34-37.
• Snoeckx Y, et al. 2008. Pregnancy outcomes in women taking infliximab: The infliximab safety database. Arthr Rheum. 58:S426.
• Weber-Schoendorfer C, et al. 2015. Pregnancy outcome after TNF-α inhibitor therapy during the first trimester: a prospective multicentre cohort study. British Journal of Clinical Pharmacology. 80(4):727-739.

Selected References:

• American College of Obstetrics and Gynecology. 2018. ACOG Practice Bulletin No. 189: nausea and vomiting of pregnancy. Obstet Gynecol, 131(1):e15-e30.
• Arsenault MY, et al. 2002. The management of nausea and vomiting of pregnancy. J Obstet Gynaecol Can, 24(10):817-831.
• Ashkenazi-Hoffnung L, et al. 2013. Evaluation of the efficacy and safety of bi-daily combination therapy with pyridoxine and doxylamine for nausea and vomiting of pregnancy. Isr Med Assoc J, 15(1):23-26.
• Atanackovic G. 2001. The safety of higher than standard dose of doxylamine-pyridoxine (Diclectin) for nausea and vomiting of pregnancy. J Clin Pharmacol, 41(8):842-845.
• Banihani S. A. (2017). A Systematic Review Evaluating the Effect of Vitamin B6 on Semen Quality. Urology journal, 15(1), 1–5.
• Berard A, et al. 2019. New evidence for concern over the risk of birth defects from medications for nausea and vomiting of pregnancy. J Clin Epidemiol, 116: 39-48.
• Brent RL. 1995. Bendectin: review of the medical literature of a comprehensively studied human nonteratogen and the most prevalent tortogen-litigen. Reprod Toxicol, 9(4):337-349.
• Dayan-Schwartz A, et al. 2024. The efficiency of cabergoline vs pyridoxine for lactation inhibition-a randomized controlled trial. Am J Obstet Gynecol. 2024 May;230(5):561.e1-561.e8.
• Einarson TR, et al. 1988. A method for meta-analysis of epidemiological studies. Drug Intell Clin Pharm, 22:813-824.
• Faraoni L, et al. 2020. Doxylamine use in pregnancy and neonatal abstinence syndrome: A case report. Reprod Toxicol, 97:6.
• Fisher A, et al. 2022. Patterns of antiemetic medication use during pregnancy: a multi-country retrospective cohort study. Plos One, 17(12):1-14.
• Guala, A, et al. 2022. Vitamin B6 Neonatal Toxicity. Case reports in pediatrics, 2022,
• Hansen C, et al. 2020. Use of antihistamine medications during early pregnancy and selected birth defects: The National Birth Defects Prevention Study, 1997-2011. Birth Defects Res, 112:1234-1252.
• He L, et al. 2024 The potential hazards of high doses of vitamin B6 in treating nausea and vomiting in pregnancy: A systematic review. Int J Gynaecol Obstet. 10.1002/ijgo.16032
• 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.
• Koren G, et al. 2015. Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial. BMC Pregnancy Childbirth, 15:59.
• Kutcher JS, et al. 2003. Bendectin and birth defects. II: Ecological analyses. Birth Defects Res A Clin Mol Teratol, 67:88-97.
• Madjunkova S, et al. 2014. The delayed-release combination of doxylamine and pyridoxine (Diclegis^®/Diclectin^®) for the treatment of nausea and vomiting of pregnancy. Pediatr Drugs, 16:199-211.
• Matthews A, et al. 2015. Interventions for nausea and vomiting in early pregnancy. Cochrane Database Syst Rev, (9):CD007575.
• McKeigue PM, et al. 1994. Bendectin and birth defects: I. A meta-analysis of the epidemiologic studies. Teratology, 50:27-37.
• Nuangchamnog N, Niebyl J. 2014. Doxylamine succinate-pyridoxine hydrochloride (Diclegis) for the management of nausea and vomiting in pregnancy: an overview. Int J Wom Health, 6:401-9.
• Nulman I, et al. 2009. Long-term neurodevelopment of children exposed to maternal nausea and vomiting of pregnancy and Diclectin. J Pediatr, 155(1):45-50.
• Nulman I, Koren G. 2009. Pharmacokinetic comparison of a delayed-release combination of doxylamine succinate and pyridoxine hydrochloride (Diclectin) and oral solutions of these drugs in healthy women of childbearing age. Can J Clin Pharmacol. 16(3):29.
• Persaud N, et al. 2018. Doxylamine-pyridoxine for nausea and vomiting of pregnancy randomized placebo controlled trial: Prespecified analyses and reanalysis. Plos One, 13(1):e0189978.
• Schrager, N. L., et al. & for the National Birth Defects Prevention Study. 2023. The association of nausea and vomiting of pregnancy, its treatments, and select birth defects: Findings from the National Birth Defect Prevention Study. Birth defects research,115(3), 275–289.
• Shrateh ON, et al. 2024. Comparing pyridoxine with dopaminergic agonists (cabergoline and bromocriptine): Unveiling the strategy for lactation inhibition – A systematic review of clinical trials. J Gynecol Obstet Hum Reprod. 2024 Jun;53(6):102783.
• Tyl RW, et al. 1988. Developmental toxicity evaluation of Bendectin in CD rats. Teratology, 37:539-552.
• Wu, X., et al. 2023. Acupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy : A Randomized, Controlled, 2 × 2 Factorial Trial. Annals of internal medicine, 176(7), 922–933.

Selected References:

• Ali Sakr Esa W, et al. 2009. Epidural analgesia in labor for a woman with an intrathecal baclofen pump. Int J Obstet Anesth. 2009 Jan;18(1):64-6.  
• Andrade C. 2020. Individualized, High-Dose Baclofen for Reduction in Alcohol Intake in Persons With High Levels of Consumption, J Clin Psychiatry. Aug 4;81(4):20f13606. 
• Baclofen Product Label. 2023: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=04dac0f6-cc6c-4959-9bca-a6e4a99690f3. Accessed 11/2024. 
• Balakirouchenane D, et al. 2021. Pharmacokinetics of Baclofen in a Full-Term Newborn after Intrauterine Exposure: A Case Report. Neonatology; 118(5):624-627.   
• Barker KDD, et al. 2025. Three consecutive pregnancies in a woman with spastic cerebral palsy being treated with intrathecal baclofen therapy. Int J Gynaecol Obstet;168(3):893-895.  
• Bernard N, et al. 2012. Pregnancy outcomes after in utero exposure to baclofen. Reprod Toxicol; 34(2):157. 
• Briggs, GG and Freeman RK. 2016. Drugs in Pregnancy and Lactation, Tenth Edition; Wolters Kluwer. 122-3. 
• Dalton CM, et al. 2008. The safety of baclofen in pregnancy: intrathecal therapy in multiple sclerosis. Mult Scler; 14(4):571-2. 
• Delhaas EM, Verhagen J. 1992. Pregnancy in a quadriplegic patient treated with continuous intrathecal baclofen infusion to manage her severe spasticity. Case report. Paraplegia; 30: 527-8. 
• Engrand N, et al. 2001. Intrathecal baclofen for severe tetanus in a pregnant woman. Eur J Anaesthesiol; 18:261-3. 
• Eriksson G, Swahn CG. 1981. Concentrations of baclofen in serum and breast milk from a lactating woman. Scand J Clin Lab Invest; 41(2):185-7.  
• Freeman, EH and Delaney, RM. 2016. Neonatal Baclofen Withdrawal: A Case Report of an Infant Presenting with Severe Feeding Difficulties.J Pediatr Nurs. May-Jun: 31(3):346-9.  
• Goldkamp J, et al. 2011. Stiff person syndrome and pregnancy. Obstet Gynecol; 118(2 Pt 2):454-457.   
• Hale TW and Rowe HE. 2015. Medications and Mother’s Milk 2017. Springer Publishing Co. 93-4. 
• Hara T, et al. 2018. Pregnancy and breastfeeding during intrathecal baclofen therapy – A case study and review. NMC Case Rep J. Jun 25;5(3):65-8. 
• Hyser, CL and Drake, ME. 1984. Status Epilepticus after Baclofen Withdrawal. J Natl Med Assoc; 76(5):533, 537-8.  
• Lin HH, et al. 2014. Baclofen distribution into breast milk-a potential for toxicity? J Med Toxicol; 10:86.  
• Lin HH, et al. 2014. Prevention of neonatal abstinence syndrome in the setting of intrauterine baclofen exposure. J Med Toxicol; 10:85-6.   
• Logge WB, et al. 2020. Baclofen modulates cardiovascular responses to appetitive cues in treatment-seeking alcohol use disorder individuals. Hum Psychopharmacol. Mar;35(2):e2722. 
• Mahdavinasab SM, et al. 2019. Baclofen as an adjuvant therapy for autism: a randomized, double-blind, placebo-controlled trial. Eur Child Adolesc Psychiatry. Dec;28(12):1619-1628. 
• Mendez-Lucena C, et al. 2014. Intrathecal baclofen for dystonia treatment during pregnancy: A case report. Neurologia; 31(2): 131-132. 
• Moran LR, et al. 2004. Intrauterine Baclofen Exposure: A Multidisciplinary Approach. Pediatrics; 114(2): e267-8. 
• Morton CM, et al. 2009. Intrathecal baclofen administration during pregnancy: a case series and focused clinical review. PM R. Nov;1(11):1025-9.  
• Mousigian MA, et al. 2022. Neonatal baclofen withdrawal following intrauterine exposure. J Pediatr Rehabil Med; 15(2):389-394. 
• Muñoz FC et al. 2020. Pregnancy outcome in a woman exposed to continuos intrathecal baclofen unfusion. Ann Pharmacother. Jul-Aug 2000;34(7-8):956 
• Ratnayaka BD, et al. 2001. Drug points: Neonatal convulsions after withdrawal of baclofen. BMJ. Jul 14;323(7304):85.  
• Roberts AG, et al. 2003. Intrathecal baclofen pump implantation during pregnancy. Neurology; 61:1156-7. 
• Weatherby SJ, et al. 2004. Pregnancy in stiff-limb syndrome. Mov Disord; 19(7):852-4. 
• Yang K, et al. 2024. Intrathecal baclofen pump in pregnancy: case report, literature review, and management considerations. Reg Anesth Pain Med; 49(12):919-922. 

Selected References:

• American Academy of Pediatrics. 2009. Varicella-zoster infections. In: Pickering LK, Baker CJ, Kimberlin DW, Long SS, eds. Red Book: 2009. Report of the Committee on Infectious Diseases. 28th ed. Elk Grove Village, IL: American Academy of Pediatrics;714-727 
• Arthur I. Eidelman, et al. 2012. Breastfeeding and the Use of Human Milk. Pediatrics March 2012; 129 (3): e827–e841. 
• Bohlke K, et al. 2003. Postpartum varicella vaccination: is the vaccine virus excreted in breast milk? Obstet Gynecol 102(5 Pt 1):970-977.  
• Centers for Disease Control and Prevention. 1996. Prevention of varicella. MMWR; 45(RR-11);1-36. 
• Centers for Disease Control and Prevention. 2013. Updated Recommendations for Use of VariZIG — United States, 2013. MMWR.  62(28)574-576. 
• Centers for Disease Control and Prevention. 2016. Guidelines for vaccinating pregnant women (2012, updated 2016). http://www.cdc.gov/vaccines/pubs/preg-guide.htm  
• Chan DYL, et al. 2017. Human varicella zoster virus is not present in the semen of a man affected by chickenpox during the in vitro fertilisation of is wife. Andrologia 49(10):e12822. 
• Cohen A, et al.  Congenital varicella syndrome: the evidence for secondary prevention with varicella-zoster immune globulin. CMAJ:183(2):204-208. 
• Committee on Infectious Diseases, American Academy of Pediatrics. 1995. Recommendations for the use of live attenuated varicella vaccine. Pediatrics; 95:791-796. 
• Enders, G et al. 1994. Consequences of varicella and herpes zoster in pregnancy: prospective study of 1739 cases.” Lancet (London, England) vol. 343,8912: 1548-51.  
• Fabiano, Valentina et al. 2013. Herpes zoster in an immunocompetent boy following intrauterine exposure to varicella-zoster virus.” Cutis vol. 91,3: 127-8, 140. 
• Frederick IB, et al. 1986. Excretion of varicella-herpeszoster in breast milk. Am J Obstet Gynecol; 154:1116-1117. 
• Gruslin A, et al; SOGC. 2008. Immunization in pregnancy: No. 220, December 2008. Int J Gynaecol Obstet; 105(2):187-191. 
• Harger, James H et al. 2002. Frequency of congenital varicella syndrome in a prospective cohort of 347 pregnant women.” Obstetrics and gynecology vol. 100,2: 260-5. 
• Hayward K, et al. 2018. Management of herpes zoster (shingles) during pregnancy. J Obstet Gynaecol 38(7):887-894. 
• Konopka, A., Szczepaniak, Z., Wdowiak, N., Lissak, K., Komarów, M., Choinka, M., … Kalisiak, J. (2024). A Comprehensive Review of TORCH Syndrome: Characterization and Prevention Strategies. Quality in Sport, 21, 53987.  
• Lamont, Ronald F et al. 2011. Varicella-zoster virus (chickenpox) infection in pregnancy.” BJOG : an international journal of obstetrics and gynaecology vol. 118,10: 1155-62. 
• Marin M, et al. 2013. Closure of Varicella-Zoster Virus-Containing Vaccines Pregnancy Registry – United States. MMWR. 63(33);732-733.  
• Mohsin, M. S., Gaballa, N. F., & Elsayed, W. (2024). Varicella Orchitis: A Case Report and Literature Review. Cureus, 16(8), e66978.  
• National Center for Immunization and Respiratory Diseases. 2011. General recommendations on immunization — recommendations of the Advisory Committee on  Immunization Practices (ACIP). MMWR Recomm Rep. 60(2):1-64. Erratum in: MMWR Recomm Rep. 2011:60:993.  
• Petignat, P et al. 2001. Fetal varicella-herpes zoster syndrome in early pregnancy: ultrasonographic and morphological correlation. Prenatal diagnosis vol. 21,2 (2001): 121-4. 
• Tan MP, Koren G. 2006. Chickenpox in pregnancy: revisited. Reprod Toxicol; 21(4):410-20.  

Selected References:

• Aagaard J, et al. 1991. Prostatic tissue levels of ofloxacin. Urology, 38:380-382.
• Cahill JB Jr, et al. 2005. Levofloxacin secretion in breast milk: a case report. Pharmacotherapy, 25:116-118.
• Caplin Sterile Limited. 2024. Ofloxacin product label. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo. Accessed June 20 2024.
• Danisovicova A, et al. 1994. Magnetic resonance imaging in children receiving quinolones: no evidence of quinolone-induced arthropathy. A multicenter survey. Chemotherapy, 40:209-214.
• Drobac PC, et al. 2005. Treatment of multidrug-resistant tuberculosis during pregnancy: long-term follow-up of 6 children with intrauterine exposure to second-line agents. Clin Infect Dis, 40:1689-1692.
• Erhart B, et al. 1998. Ofloxacin: the next generation of antibiotic in sperm and embryo cultures for assisted reproductive technologies. Fertil Steril, 69(2):246-251.
• Falagas ME, et al. 2007. Arrhythmias associated with fluoroquinolone therapy. Int J Antimicrob Agents, 29(4):374-379.
• Giamarellou H, et al. 1989. Pharmacokinetics of three newer quinolones in pregnant and lactating women. Am J Med, 87(5A):49S-51S.
• Loebstein R, et al. 1998. Pregnancy outcome following gestational exposure to fluoroquinolones: a multicenter prospective controlled study. Antimicrob Agents Chemother, 42:1336-1339.
• Muanda Ft, et al. 2017. Use of antibiotics during pregnancy and the risk of major congenital malformations: a population based cohort study. Br J Clin Pharmacol, 83:2557-2571.
• Naber KG, et al. 1993. Penetration of ofloxacin into prostatic fluid, ejaculate and seminal fluid. Infection, 21(2):98-100.
• Nivagen Pharmaceuticals Inc. 2023. Ofloxacin product label. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo. Accessed June 20 2024.
• Padberg S, et al. 2014. Observational cohort study of pregnancy outcomes after first-trimester exposure to fluoroquinolones. Antimicrob Agents Chemother, 58(8):4392-4398.
• Peled Y, et al. 1991. Ofloxacin during the second trimester of pregnancy. DICP, 25(11):1181-1182.
• Schaefer C, et al. 1996. Pregnancy outcome after prenatal quinolone exposure. Evaluation of a case registry of the European Network of Teratology Information Services (ENTIS). Eur J Obstet Gynecol Reprod Biol, 69(2):83-89.
• Schramm P. 1986. Ofloxacin: concentration in human ejaculate and influence on sperm motility. Infection, 14 Suppl 4:S274-S275.
• Shao S, et al. 2023. Association between antibiotic exposure and the risk of infertility in women of childbearing age: a case-control study. Ecotoxicol Environ Saf, 249: 114414.
• Shin YJ, et al. 2018. Pregnancy outcomes in women reporting exposure to ofloxacin in early pregnancy. J Obstet Gynaecol, 38(6):807-812.
• Wilton LV, et al. 1998. The outcomes of pregnancy in women exposed to newly marketed drugs in general practice in England. British J Obstet Gynecol, 105:882-889.
• Yamaguchi H, et al. 2007. Post-marketing surveillance of the safety of levofloxacin in Japan. Chemotherapy, 53(2):85-103.