Selected References:

• Brooks C, et al. 1977. Linear growth of children with limb deformities following exposure to thalidomide in utero. Acta Paediatr Scan, 66:673-675.  
• Castilla E, et al. 1996. Thalidomide, a current teratogen in South America. Teratology, 54:273-277.  
• Gao S, et al. 2020. Recent advances in the molecular mechanism of thalidomide teratogenicity. Biomed Pharmacother, 127:110114.  
• Guo L, et al. 2023. Inflammatory bowel disease can reduce ovarian reserve function in women: a systematic review and meta-analysis. Medicine (Baltimore), 102(11):e33113.  
• Gollop T, et al. 1987. Prenatal diagnosis of thalidomide syndrome. Prenat Diagn, 7:295-298.  
• Ito T, et al. 2020. Molecular mechanisms of thalidomide and its derivatives. Proc Jpn Acad Ser B Phys Biol Sci, 96(6):189-203. 
• Klein-Weigel PF, Ding-Greiner C. 2025. Cardiovascular manifestations of thalidomide embryopathy. Vasa, 54(5):299-304.  
• Mahesri M, et al. 2024. Trends in use and evidence of adherence to risk evaluation and mitigation strategy pregnancy testing requirements for thalidomide, lenalidomide, and pomalidomide in the USA, 2000-2020. Drug Saf, 47(9):909-919.  
• Miller MT, et al. 2009. Thalidomide and misoprostol: opthalmologic manifestations and associations both expected and unexpected. Birth Defects Res A Clin Mol Teratol, 85(8):667-676.  
• Peng X, et al. 2017. Thalidomide results in diminished ovarian reserve in reproductive age female IBD patients. Medicine (Baltimore), 96(21):e6540.  
• Prescriber Guide to (THALOMID REMS™ ) Risk Evaluation and Mitigation Strategy (REMS)™ Program. (2014). Retrieved from https://www.fda.gov/media/79047/download 
• Rodier PM, 2000. The early origins of autism. Scientific American, 282:56-63.  
• Rodier PM. 2002. Converging evidence for brain stem injury in autism. Dev Psychopathol, 14(3):537-557. 
• Smithells R. 1992. Recognition of thalidomide defects. J Med Genet, 29:716-723.  
• Sterling D, et al. 1997. Thalidomide: a surprising recovery. J Am Pharm Assn, 3:306-313.  
• Stromland K, et al. 1993. Thalidomide embryopathy: revisited 27 years later. Acta Ophthalmol (Copen), 71:238-245.  
• Stromland K, et al. 1994 Autism in the thalidomide embryopathy: a population study. Dev. Med. Child Neurol, 36:351-356.  
• Vargesson N. 2019. The teratogenic effects of thalidomide on limbs. J Hand Surg Eur Vol, 44(1):88-95.  
• Xiang P, et al. 2023. Clinical characteristics and risk factors of ovarian reserve decreases in women with Crohn’s disease: a case-control study. J Ovarian Res, 16(1):34.  

Selected References:

• Bateman BT, et al. 2015. Statins and congenital malformations: cohort study. BMJ,350:h1035. 
• Boyle AK, et al. 2019. Repurposing simvastatin as a therapy for preterm labor: evidence from preclinical models. FASEB J, 33:2743–2758.  
• Chang J, et al. 2021. Perinatal outcomes after statin exposure during pregnancy. JAMA Netw Open, 4(12):e2141321.  
• Cleary KL, et al. 2014. Challenges of studying drugs in pregnancy for off-label indications: pravastatin for preeclampsia prevention. Semin Perinatol, 38(8):523-527. 
• Constantine MM, Cleary K. 2013. Pravastatin for the prevention of preeclampsia in high-risk pregnant women. Obstet Gynecol, 121(2 Pt 1):349-353. 
• Döbert M, et al. 2021. Pravastatin versus placebo in pregnancies at high risk of term preeclampsia. Circulation, 144(9):670-679. 
• Hirsch A, et al. 2022. The effect of statins exposure during pregnancy on congenital anomalies and spontaneous abortions: A systematic review and meta-analysis. Front Pharmacol, 13.  
• Jay RH, et al. 1991. Effects of pravastatin and cholestyramine on gonadal and adrenal steroid production in familial hypercholesterolaemia. Br J Clin Pharmacol, 32(4):417–422. 
• Kane AD, et al. 2022. Combined statin and glucocorticoid therapy for the safer treatment of preterm birth. Hypertension, 80(4).  
• Kay HY, et al. 2025. Pregnancy and neonatal outcomes after fetal exposure to statins among women with dyslipidemia: a nationwide cohort. Eur J Pediatr, 184(6):340. 
• Kazmin A, et al. 2007. Risk of statin use during pregnancy: a systematic review. J Obstet Gynaecol Can, 29(11):906. 
• Kusters DM, et al. 2012. Statin use during pregnancy: a systematic review and meta-analysis. Expert Rev Cardiovasc Ther, 10(3):363-378. 
• Maierean SM, et al. 2018. The potential role of statins in preeclampsia and dyslipidemia during gestation: a narrative review. Expert Opin Investig Drugs, 27(5):427-435. 
• McElhatton P. 2005. Preliminary data on exposure to statins during pregnancy. Reprod Toxicol, 20:471-472. 
• Morton S, Thangaratinam S. 2013. Statins in pregnancy. Curr Opin Obstet Gynecol, 25(6):433-440. 
• Mudd LM, et al. 2012. Maternal lipids at mid-pregnancy and the risk of preterm delivery. Acta Obstet Gynecol Scand, 91(6):726–735.  
• Ofori B, et al. 2007. Risk of congenital anomalies in pregnant users of statin drugs. Br J Clin Pharmacol, 64(4):496-509. 
• Omolaoye TS, et al. 2022. Statins and Male Fertility: Is There a Cause for Concern? Toxics, 10(627):1-19. 
• Raham DF, et al. 2021. Management of familial hypercholesterolemia in pregnancy. Curr Opin Lipidol, 32(6):370–377.  
• Svendsen K, et al. 2025. Risk of adverse pregnancy outcomes and impact of statin use in pregnant women with familial hypercholesterolemia. Atherosclerosis, 408:120442.  
• Taguchi N, et al. 2008. Prenatal exposure to HMG CoA reductase inhibitors: effects on fetal and neonatal outcomes. Reprod Toxicol, 26(2):175-177. 
• U.S. Food and Drug Administration. 2021. Statins: drug safety communication – FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy. Posted July 20, 2021. Available at URL: https://www.fda.gov/safety/medical-product-safety-information/statins-drug-safety-communication-fda-requests-removal-strongest-warning-against-using-cholesterol.  
• Vahedian-Azimi A, et al. 2021. Effects of statins on preeclampsia: a systematic review. Pregnancy Hypertens, 23:123-130. 
• Vahedian-Azimi A, et al. 2021. A systematic review and meta-analysis on the effects of statins on pregnancy outcomes. Atherosclerosis, 336:1–11.  
• Vahedian-Azimi A, et al. 2021. Fetal toxicity associated with statins: a systematic review and meta-analysis. Atherosclerosis, 327:59-67. 
• Winterfeld U, et al. 2013. Pregnancy outcome following maternal exposure to statins: a multicentre prospective study. BJOG, 120(4):463-471. 
• Wolfgang P, et al. 2004. Pregnancy outcome after medication with HMG-CoA reductase inhibitors in the first trimester. Reprod Toxicol, 19:254-255. 

Selected References:

• Beeder LA, et al. 2010. Effect of antidepressant medications on semen parameters and male fertility. International Journal of Urology 27.1: 39-46. 
• Dao K, et al. 2023. Reproductive safety of trazodone after maternal exposure in early pregnancy: a comparative ENTIS cohort study. Journal of Clinical Psychopharmacology 43.1: 12. 
• Einarson A, et al. 2003. A multicentre prospective controlled study to determine the safety of trazodone and nefazodone use during pregnancy. Can J Psychiatry 48(2):106-110.  
• Einarson A, et al. 2009. Incidence of major malformations in infants following antidepressant exposure in pregnancy: results of a large prospective cohort study. Can J Psychiatry 54(4):242 246.  
• Glasgow-Osment B, et al. 2025. The effects of trazodone exposure during pregnancy on fetal outcomes: a systematic review. Eur J Clin Pharmacol 81: 1401-1408. 
• Khazaie H, et al. 2013. Insomnia treatment in the third trimester of pregnancy reduces postpartum depression symptoms: a randomized clinical trial. Psychiatry Res. 210(3):901-5.  
• McElhatton PR, et al. 1996. The outcome of pregnancy in 689 women exposed to therapeutic doses of antidepressants. A collaborative study of the European Network of Teratology Information Services (ENTIS). Reprod Toxicol 10:285-94. 
• Misri S and Sivertz K. 1991. Tricyclic drugs in pregnancy and lactation: a preliminary report. Int J Psychiatry Med 21:157-171. 
• Rivett KF and Barcelona PS. 1974. Toxicology of trazodone. Mod Probl Pharmacopsychiatry 9:76-86.  
• Rosa F. 1994. Medicaid antidepressant pregnancy exposure outcomes. Reprod Toxicol 8(5):444-445. 
• Verbeeck RK, et al. 1986. Excretion of trazodone in breast milk. Br J Clin Pharmacol 22(3):367-370.  

Selected References:

• Bokun V, et al. 2019. Respiratory Syncytial Virus Exhibits Differential Tropism for Distinct Human Placental Cell Types with Hofbauer Cells Acting as a Permissive Reservoir for Infection. PloS One; 14(12):e0225767. 
• Centers for Disease Control and Prevention (CDC). 08/2023. Respiratory Syncytial Virus Infection (RSV) web page: https://www.cdc.gov/rsv/index.html [Accessed 10/2025]. 
• Centers for Disease Control and Prevention (CDC). 08/2024. RSV Vaccine Guidance for Pregnant Women. https://www.cdc.gov/rsv/hcp/vaccine-clinical-guidance/pregnant-people.html. [Accessed 10/205]. 
• Chu HY, et al. 2016. Clinical Presentation and Birth Outcomes Associated with Respiratory Syncytial Virus Infection in Pregnancy. PLoS One. 2016 Mar 31;11(3):e0152015.  
• Chiba Y, et al. 1987. Effect of breast feeding on responses of systemic interferon and virus-specific lymphocyte transformation in infants with respiratory syncytial virus infection. J Med Virol; 21(1):7-14. 
• Downham MA, et al. 1976. Breast-feeding protects against respiratory syncytial virus infections. Br Med J; 2:274-6. 
• Ferolla FM, et al. 2013. Macronutrients during pregnancy and life-threatening respiratory syncytial virus infections in children. Am J Respir Crit Care Med; 187(9):983-90.  
• Fonceca AM, et al. 2017. Infective Respiratory Syncytial Virus is Present in Human Cord Blood Samples and Most Prevalent During Winter Months. PloS One; 12(4):e0173738.  
• Galanti M, et al. 2019. Rates of asymptomatic respiratory virus infection across age groups. Epidemiol Infect; 147:e176.  
• Hause A, et al. 2021. Adverse Outcomes in Pregnant Women Hospitalized with Respiratory Syncytial Virus Infection: A Case Series, Clinical Infectious Diseases: 72(1):138–140. 
• Irvine LM, et al. 1990. Elevated viral antibody titres in spontaneous abortion. FEMS Microbiol Immunol; 2(1):23-7.  
• Kenmoe S, et al; PROMISE Investigators. 2024. Burden of Respiratory Syncytial Virus–Associated Acute Respiratory Infections During Pregnancy. The Journal of Infectious Diseases 229(Suppl 1): S51–S60. 
• Manti S, et al. 2017. Detection of Respiratory Syncytial Virus (RSV) at Birth in a Newborn with Respiratory Distress. Pediatr Pulmonol; 52(10):e81–4.  
• Manti S, et al. 2020. Respiratory syncytial virus seropositivity at birth is associated with adverse neonatal respiratory outcomes. Pediatr Pulmonol; 55(11):3074-3079.  
• Mineva G & Philip R. 2022. Impact of Breastfeeding on the Incidence and Severity of RSV Bronchiolitis in Infants: Systematic Review. Pediatrics; 149 (1 Meeting Abstracts): 280. 
• Nandapalan N, et al. 1987. Mammary immunity of mothers of infants with respiratory syncytial virus infection. J Med Virol; 22:277-87. 
• Okamoto Y, et al. 1989. Effect of breast feeding on the development of anti-idiotype antibody response to F glycoprotein of respiratory syncytial virus in infant mice after post-partum maternal immunization. J Immunol; 142:2507-12. 
• Patel SM, et al. 2019. Placental transfer of respiratory syncytial virus antibody among HIVexposed, uninfected infants. Journal of the Pediatric Infectious Diseases Society. Pediatric Infect Dis Soc. 2020 Jul 13;9(3):349-356.  
• Piedimonte G, et al. 2013. Vertical transmission of respiratory syncytial virus modulates pre- and postnatal innervation and reactivity of rat airways. PLoS One; 8(4):e61309. 
• Regan AK, et al. 2018. Respiratory Syncytial Virus Hospitalization During Pregnancy in 4 High-Income Countries, 2010-2016. Clin Infect Dis. 67(12):1915–8. 
• Riccò M, et al. 2022. Respiratory Syncytial Virus in Pregnant Women: Systematic Review and Meta-Analysis. Women; 2(2):147-160. 
• Scott R, et al. 1985. Cellular reactivity to respiratory syncytial virus in human colostrum and breast milk. J Med Virol; 17(1):83-93.  
• Weinberg A, et al. 2018. Factors associated with lower respiratory tract infections in HIV-exposed uninfected infants. AIDS Research and Human Retroviruses. 34(6):527–535. 
• Wheeler SM, et al. 2015. Maternal Effects of Respiratory Syncytial Virus Infection during Pregnancy. Emerg Infect Dis; 21(11):1951-1955. 

Selected References:

• AAP Committee on Drugs. 2001. The transfer of drugs and other chemicals into human milk. Pediatrics 108:776-789.  
• Acar S, et al. 2019. Pregnancy outcomes following quinolone and fluoroquinolone exposure during pregnancy: A systematic review and meta-analysis. Reprod Toxicol, 85:65-74. 
• Berkovitch M, et al. 1994. Safety of the new quinolones in pregnancy. Obstet Gynecol, 84(4):535-538.  
• Boissiere-O’Neill T, et al. 2025. Exposure to Systemic Antimicrobials During Pregnancy and Risk of Miscarriage: A Population-Based Registry Study. BJOG. 
• Bomford JAL, et al. 1993. Ciprofloxacin use during pregnancy. Drugs, 45(S3): 461-462. 
• Cavusoglu I, et al. 2016. Evaluation of teratogenic effects of ciprofloxacin in pregnant women exposed due to urinary tract infections (abstract). Reprod Toxicol, 60:178. 
• Cover DL, Mueller BA. 1990. Ciprofloxacin penetration into human breast milk: a case report. DICP, 24:703-704.  
• 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. 
• Gardner D, et al. 1992. Simultaneous concentrations of ciprofloxacin in breast milk and in serum in mother and breast-fed infant. Clin Pharm, 11:352-354.  
• Kabeya CM, et al. 1995. Ciprofloxacin for multiresistant enteric fever in pregnancy. The Lancet, 346:307-308. 
• Leung D, et al. 1995. Treatment of typhoid in pregnancy. The Lancet, 346:648.  
• Loebstein R, et al. 1998. Pregnancy outcome following gestational exposure to fluoroquinolones: a multicenter prospective controlled study. Antimicrob Agents Chemother, 42(6):1336-1339.  
• Meaney-Delman D, et al. 2013 Prophylaxis and treatment of anthrax in pregnant women. Obstet Gynecol, 122(4):885-900.  
• 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.  
• Nahum G, et al. 2006. Antibiotic use in pregnancy and lactation. Obstet Gynecol, 107(5):1120-1138. 
• Noergaard M, et al. 2022. Ciprofloxacin exposure and adverse pregnancy outcomes: A Danish nationwide cohort study. BJOG, 129(9):1503-1511.  
• Padberg S, et al. 2014. Observational cohort study of pregnancy outcomes after first-trimester exposure to fluoroquinolones. Antimicrob Agents Chemother, 58(8):4392-4398. 
• 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, 69:83-89.  
• Schluter G. 1989. Ciprofloxacin: toxicologic evaluation of additional safety data. The Am J Med, 87(5A):S37-S39. 
• Van Wattum JJ, et al. 2019. Antibiotics and lactation: An overview of relative infant doses and a systematic assessment of clinical studies. Basic Clin Pharmacol Toxicol, 124(1):5-17. 
• Xiang DC, et al. 2024. Pregnancy-related adverse events and congenital disorders associated with fluoroquinolones: A real-world pharmacovigilance study of the FDA Adverse Event Reporting System (FAERS). Heliyon. 10(18):e37547.  
• Xiong W, et al. 2024. Association between maternal antibiotic exposure and emotional and behavioural problems in children at four years of age: A biomonitoring-based prospective study. Ecotoxicol Environ Saf. 284:116949.  
• Yefet E, et al. 2018. The safety of quinolones and fluoroquinolones in pregnancy: a meta-analysis.