Selected References:

• Akhigbe RE, et al. 2022. Codeine alters female reproductive function by targeting ovarian steroidogenesis and folliculogenesis via the induction of oxidative stress, inflammation, and apoptosis, Reproductive Toxicology 109: 1-9.  
• Azuine RE, et al. 2019. Prenatal risk factors and perinatal and postnatal outcomes associated with maternal opioid exposure in an urban, low-income, multiethnic US population. JAMA network 2(6): e196405-196405.  
• Berlin CM, Jr, et al. 2009. Safety issues of maternal drug therapy during breastfeeding. Clinical pharmacology and therapeutics  85(1): 20-22. 
• Bowie, AC, et al. 2022. Prescribed opioid analgesics in early pregnancy and the risk of congenital anomalies: a population-based cohort study. CMAJ. 194(5): E152-E162. 
• Bracken MB. 1986. Drug use in pregnancy and congenital heart disease in offspring. N Engl J Med. 314(17):1120. 
• Bracken MB, Holford TR. 1981. Exposure to prescribed drugs in pregnancy and association with congenital malformations. Obstet Gynecol. 58(3):336-344. 
• Brogly SB, et al. 2021. Prenatal opioid analgesics and the risk of adverse birth outcomes. Epidemiology. 32(3), 448–456. 
• Brogly SB, et al. 2023. Safety of prenatal opioid analgesics: Do results differ between public health insurance beneficiary and population-based cohorts? Birth Defects Res. 115(5):555-562. 
• Broussard CS, et al. 2011. Maternal treatment with opioid analgesics and risk for birth defects. Am J Obstet Gynecol. 204(4):314.e1-11.
• Corsi DJ, et al. 2020. Association of Maternal opioid use in pregnancy with adverse perinatal outcomes in Ontario, Canada, From 2012 to 2018. JAMA Netw Open. 3(7):e208256. 
• Corsi DJ, et al. 2021. The effects of opioids on female fertility, pregnancy and the breastfeeding mother‐infant dyad: A Review. Basic Clin Pharmacol Toxicol. 128(5):635-641. 
• Esposito, DB, et al. 2022. Characteristics of prescription opioid analgesics in pregnancy and risk of neonatal opioid withdrawal syndrome in newborns. JAMA Netw Open 5(8): e2228588. 
• Fältmarch S, et al. 2019. Use of opioids during pregnancy and effects of pregnancy outcomes. Pharmacoepidemiol Drug Saf. 28: 1239– 1245.  
• Fishman B, et al. 2019. Pregnancy outcome following opioid exposure: A cohort study. PLOS ONE 14(7): e0219061 
• Flannagan KS, et al. 2020. Is opioid use safe in women trying to conceive? Epidemiology. 31(6): 844–851. 
• Fronczak CM, et al. 2012. The insults of illicit drug use on male fertility. Journal of andrology. 33(4): 515-528. 
• Interrante JD, et al. 2021. Prescription opioid use during pregnancy and risk for preterm birth or term low birthweight. Journal of opioid management 17(3):215-225. 
• Ito S. 2018. Opioids in breast milk: Pharmacokinetic principles and clinical implications. The Journal of Clinical Pharmacology, 58: S151-S163. 
• Juurlink DN, et al. 2012. Postpartum maternal codeine therapy and the risk of adverse neonatal outcomes: a retrospective cohort study. Clinical Toxicol. 50:5.  
• Kallen B,  Reis M. 2015. Use of tramadol in early pregnancy and congenital malformation risk. Reprod Toxicol. 58:246-251. 
• Kelly LE, et al. 2013. A clinical tool for reducing central nervous system depression among neonates exposed to codeine through breast milk. PLoS ONE. 8(7):370073. 
• Khan K,  Chang J. 1997. Neonatal abstinence syndrome due to codeine. Arch Dis Child. 76:F59-F60.  
• Konijnenberg C, el at. 2022. Verbal and nonverbal memory in school-aged children born to opioid-dependent mothers. Early human development, 171, 105614. 
• Lazaryan M,  et al. 2015. Codeine should not be prescribed for breastfeeding mothers or children under the age of 12. Acta paediatrica 104(,6): 550-556. 
• Lind JN, et al. 2017. Maternal use of opioids during pregnancy and congenital malformations. A Systematic Review. Pediatrics. 139(6):e20164131.  
• Mactier H, et al. 2020. Prenatal opioid exposure – Increasing evidence of harm. Early human development, 150, 105188. 
• Mangurten HH. 1980. Neonatal codeine withdrawal in infants of non-addicted mothers. Pediatrics. 65:159-160. 
• Meny RG, et al. 1993. Codeine and the breastfed neonate. Journal of human lactation  9(4): 237-240. 
• Nair V, et al. 2012. Neonatal withdrawal syndrome due to maternal codeine use. Paediatr Child Health. 17(5):e40-e41. 
• Nezvalová-Henriksen K, et al. 2011. Effects of codeine on pregnancy outcomes from a large population-based cohort study. Eur J Clin Pharmacol. 67:1253-1261. 
• Rothman KJ, et al. 1979. Exogenous hormones and other drug exposures of children with congenital heart disease. Am J Epidemiol. 109(4):433-439. 
• Rubenstein E, et al. 2019. Brief Report: Maternal opioid prescription from preconception through pregnancy and the odds of autism spectrum disorder and autism features in children. Journal of autism and developmental disorders, 49(1): 376–382. 
• Saxén I. 1975. Associations between oral clefts and drugs taken during pregnancy. Int J Epidemiol. 4(1):37-44. 
• Sachs, Hari Cheryl, and Committee On Drugs. 2013. The transfer of drugs and therapeutics into human breast milk: an update on selected topics. Pediatrics  132(3): e796-809. 
• Shaw GM, et al. 1992. Congenital cardiac anomalies relative to selected maternal exposures and conditions during early pregnancy. Eur J Epidemiol. 8(5):757-760. 
• Shaw GM, et al. 1998. Maternal illness, including fever and medication use as risk factors for neural tube defects. Teratology. 57(1):1-7. 
• Semet M, et al. 2017. The impact of drugs on male fertility: a review. Andrology, 5(4), 640-663. 
• Sujan AC, et al. 2019. Maternal prescribed opioid analgesic use during pregnancy and associations with adverse birth outcomes: A population-based study. PLoS Medicine. 16(12). 
• U.S. Food and Drug Administration. 2017. Use of codeine and tramadol products in breastfeeding women – questions and answers. Available at https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/use-codeine-and-tramadol-products-breastfeeding-women-questions-and-answers. Accessed 2 June 2025.   
• Van Leeuwen G, et al. 1965. Narcotic withdrawal reaction in a newborn infant due to codeine. Pediatrics. 36:635-636. 
• Varney B, et al. 2024. Opioid analgesic exposure during the first trimester of pregnancy and the risk of major congenital malformations in infants: a systematic review and meta-analysis†. Anaesthesia. 79(9):967-977. 
• Willmann, S, et al. 2009. Risk to the breast-fed neonate from codeine treatment to the mother: a quantitative mechanistic modeling study. Clin Pharmacol Ther. 86, 634–643. 
• Yazdy MM, et al. 2013. Periconceptional use of opioids and the risk of neural tube defects. 2013. Obstet Gynecol. 122(4):838-844. 
• Zierler S, Rothman KJ. 1985. Congenital heart disease in relation to maternal use of Bendectin and other drugs in early pregnancy. N Engl J Med. 313(6):347-352. 
• Zipursky J, Juurlink DN. 2020. The implausibility of neonatal opioid toxicity from breastfeeding. Clin Pharmacol Ther. 108(5):964-970. 

Selected References:

• Aman F, et al. 2012. Long-term cognitive and cardiac outcomes after prenatal exposure to chemotherapy in children aged 18 months or older: an observational study. Lancet Oncol, 9:256-264.
• Amant F, et al. 2019. Gynecologic cancers in pregnancy: guidelines based on a third international consensus meeting. Ann Oncol, 30(10):1601-1612.
• Aviles A, et al. 2001. Hematological malignancies and pregnancy: a final report of 84 children who received chemotherapy in utero. Clin Lymphoma, 2(3):173-177.
• Cardonick EH, et al. 2015. Development of children born to mothers with cancer during pregnancy: comparing in utero chemotherapy-exposed children with nonexposed controls. Am J Obstet Gynecol, 212(5):658.e1-658.e8.
• de Haan J et al. 2018. Oncological management and obstetric and neonatal outcomes for women diagnosed with cancer during pregnancy: a 20-year international cohort study of 1170 patients. Lancet Oncol, 19:337-346.
• Hahn KM, et al. 2006. Treatment of pregnant breast cancer patients and outcomes of children exposed to chemotherapy in utero. Cancer, 107(6):1219-1226.
• Huis In ‘t Veld EA, Van Assche IA, Amant F. Long-term outcomes of children after prenatal exposure to maternal cancer and its treatment. Acta Obstet Gynecol Scand. 2024;103(4):757-760.
• Ebert U, et al. 1997. Cytotoxic therapy and pregnancy. Pharmacology & Therapeutics 74(2):207-220.Hope For Two: The Pregnant with Cancer Network. [Cited 2010 August 16]. Available at URL: http://www.pregnantwithcancer.org.
• Imai A, et al. 2008. Preservation of female fertility during cancer treatment. Reprod Med Biol, 7(1):17-27.
• National Cancer Institute. 2009. General information about breast cancer and pregnancy. [Cited 2010 August 16]. Available at URL: http://www.cancer.gov/cancertopics/pdq/treatment/breast-cancer-and-pregnancy/Patient.
• National Cancer Institute. 2009. Understanding chemotherapy: a guide for patients and families. [Cited 2010 August 16]. Available at URL: https://www.cancer.org/cancer/treatment-types/chemotherapy.html 
• Ngu SF, et al. 2016. Chemotherapy in pregnancy. Best Pract Res Clin Obstet Gynaecol, 33:86-10.
• Signorello LB, et al. 2012. Congenital anomalies in the children of cancer survivors: a report from the childhood cancer survivor study. J Clin Oncol, 30(3):239-4
• Welt CK and Shapiro CL. 2010. Ovarian failure due to anticancer drugs and radiation. [Updated Sep. 2019].

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.