Diphenhydramine

Selected References: 

  • Abernathy A, et al. 2017. Transient fetal tachycardia after intravenous diphenhydramine administration. Obstet 130(2):374-376.
  • Aldridge T, et al. 2014. First-trimester antihistamine exposure and risk of spontaneous abortion or preterm birth. Phamacoepidemiol Drug Saf. Oct 23 (10):1043-50. 
  • Anderka M, et al, and the National Birth Defects Prevention Study. 2012. Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects. Birth Defects Res (Part A) 94:22-30.
  • Aselton P, et al. 1985, First-trimester drug use and congenital disorders. Obstet Gynecol 65(4):451-455.
  • Brost BC, et al. 1996. Diphenhydramine overdose during pregnancy: Lessons from the past. Am J Obstet Gynecol 175:1376-7.
  • Black RA, et al. 2003. Over-the-Counter Medications in Pregnancy. Am Fam 67(12):2517-2524.
  • Brzezińska-Wcisło L, et al. 2017. Pregnancy: a therapeutic dilemma. Adv Dermatol Allergol:XXXIV (5): 433-438.
  • Chaudhry SK & Susser LC. 2018. Considerations in treating insomnia during pregnancy: a literature review. Psychosomatics, 59(4), 341-348. 
  • Cohen F, et al. 2021. A randomized study of IV prochlorperazine plus diphenhydramine versus IV hydromorphone for migraine-associated symptoms: A post hoc analysis. Headache. 61(8):1227-1233. 
  • Friedman BW, et al. 2016.  Diphenhydramine as Adjuvant Therapy for Acute Migraine: An Emergency Department-Based Randomized Clinical Trial. Ann Emerg Med. 67(1):32-39.
  • Gilboa SM, et al. 2009. National Birth Defects Prevention Study: Use of antihistamine medications during early pregnancy and isolated major malformations. Birth Defects Res A Clin Mol Teratol 85(2):137-150. 
  • 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 Research, 112(16), 1234-1252.
  • Hara GS, et al. 1980. Dramamine in labor: potential boon or a possible bomb? J Kans Med Soc 81(3):134-136, 155.
  • Ito S, et al. 1993. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol 168:1393-9.
  • Kargas GA, et al. 1985. Perinatal mortality due to interaction of diphenhydramine and temazepam. N Eng J Med 313:1417-8. 
  • Li Q, et al. 2013. Assessment of antihistamine use in early pregnancy and birth defects. J Allergy Clin Immunol Pract. 1(6):666-e1. 
  • McLafferty LP, et al. 2018. Pharmacologic treatment of sleep disorders in Sleep medicine clinics, 13(2), 243-250.
  • Miller MA, et al. 2020. Sleep pharmacotherapy for common sleep disorders in pregnancy and lactation. Chest, 157(1), 184-197.
  • Moraes AP, et al. 2004. Maternal exposure to diphenhydramine during the fetal period in rats: effects on physical and neurobehavioral development and on neurochemical parameters. Neurotoxicol Teratol 26(5):681-692.
  • Moretti ME, et al. 1995. Adverse events in breastfed infants exposed to antihistamines in maternal milk. Reprod Toxicol 9: 588. 
  • O’Brien TE. 1974. Excretion of drugs in human milk. Am J Hosp Pharm 31:844-54.
  • Parken DE. 1974. Probably Benadryl withdrawal manifestations in a newborn infant. J Pediatr 85:580. 
  • Saldanha IJ, et al. 2021. Management of primary headaches during pregnancy, postpartum, and breastfeeding: A systematic review. Headache, 61(1):11-43.
  • Saxen I. 1974. Cleft palate and maternal diphenhydramine intake.  Lancet 1(7854):407-408.
  • Shenai N, et al. 2018. Fetal outcomes in intentional over-the-counter medication overdoses in Psychosomatics 4:400-404.
  • So M, et al. 2010. Safety of antihistamines during pregnancy and lactation. Can Fam Physician 56(5):427-429.
  • Spencer JP, et al. 2001. Medications in the Breast-feeding Mother. Am Fam Physician 64(1): 119-127. 
  • Wolfson AR, et al. 2022. Diphenhydramine: Time to Move on? J Allergy Clin Immunol Pract. 10(12):3124-313.

Diphenhydramine

Selected References:  

  • Andersen JT, et al. 2014. Exposure to selective serotonin reuptake inhibitors in early pregnancy and the risk of miscarriage. Obstet Gynecol 124: 655-661. 
  • Anderson KN, et al. 2020. Maternal use of specific antidepressant medications during early pregnancy and the risk of selected birth defects. JAMA Psychiatry. 77(12):1246-1255
  • Bérard A, et al. 2017. SSRI and SNRI use during pregnancy and the risk of persistent pulmonary hypertension of the newborn. Br J Clin Pharmacol. 83(5):1126-1133. 
  • Berle JO, et al. 2004. Breastfeeding during maternal antidepressant treatment with serotonin reuptake inhibitors: infant exposure, clinical symptoms, and cytochrome P450 genotypes. J Clin Psychiatry. 65:1228-1234.
  • Bonari L, et al. 2004. Perinatal risks of untreated depression during pregnancy. Can J Psychiatry 49(11):726-
  • Chambers CD, et al. 2006. Selective serotonin-reuptake inhibitors and risk of persistent pulmonary hypertension of the newborn. N Engl J Med 354:579-587.
  • Colvin L, et al. Dispensing patterns and pregnancy outcomes for women dispensed selective serotonin reuptake inhibitors in pregnancy. Birth Defects Research Part A: Clinical and Molecular Teratology 91:142-152
  • Cornet MC, et al. Maternal treatment with selective serotonin reuptake inhibitors during pregnancy and delayed neonatal adaptation: a population-based cohort study. Arch Dis Child Fetal Neonatal Ed 18;109(3):294-300.
  • Den Besten-Bertholee D, et al. Sertraline, citalopram and paroxetine in lactation: passage into breastmilk and infant exposure. Front Pharmacol 22(15):1414677.
  • Desaunay P, et al. 2024. Antidepressants and fetal death: A systematic review and disproportionality analysis in the WHO safety database (VigiBaseⓇ). Psychiatry Res 339: 
  • 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.
  • Ericson A, et al. 1999. Delivery outcome after the use of antidepressants in early pregnancy. Eur J Clin Pharmacol 55:503-508.
  • Gao SY, et al. 2018. Selective serotonin reuptake inhibitor use during early pregnancy and congenital malformations: a systematic review and meta-analysis of cohort studies of more than 9 million births. BMC Med 16(1):205.
  • Gram MA, et al. Antidepressant exposure patterns during pregnancy and risk of adverse newborn outcomes. Psychiatry Res 342:116274.
  • Grigoriadis S, et al. 2013. The effect of prenatal antidepressant exposure on neonatal adaptation: a systematic review and meta-analysis. J Clin Psychiatry.74(4):e309-20.
  • Heikkinen T, et al. 2002. Citalopram in pregnancy and lactation. Clin Pharmacol Ther 72:184-191.
  • Jimenez-Solem E, et al. 2012. Exposure to selective serotonin reuptake inhibitors and the risk of congenital malformations: a nationwide cohort study. BMJ Open:2e001148 doi:10.1136/bmjopen-2012-001148. 
  • Jordan AE, et al. 2008. Serotonin reuptake inhibitor use in pregnancy and the neonatal behavioral syndrome. J Matern Fetal Neonatal Med 21(10):745-751.
  • Huybrechts KF, et al. 2014. Antidepressant use in pregnancy and the risk of cardiac defects. N Engl J Med. 370(25):2397-407.
  • Kallen BAJ and Otterblad Olausson P. 2007. Maternal use of selective serotonin re-uptake inhibitors in early pregnancy and infant congenital malformations. Birth Defects Res A Clin Mol Teratol 79(4):301-308.
  • Kallen B and Otterblad Olausson P. 2008. Maternal use of selective serotonin re-uptake inhibitors and persistent pulmonary hypertension of the newborn. Pharmacoepidemiol Drug Saf 17:801-806.
  • Kieler H, et al. 2012. Selective serotonin reuptake inhibitors during pregnancy and risk of persistend pulmonary hypertension in the newborn: population based cohort study from the five Noridc BMJ; 344:d8012.
  • Kieviet N, et al. 2015. Risk factors for poor neonatal adaptation after exposure to antidepressants in utero. Acta Paediatr. 104(4):384-91.
  • Louik C, et al. 2007. First-trimester use of selective serotonin-reuptake inhibitors and the risk of birth defects. N Engl J Med 356:2675-2683.
  • Milosavljević JZ, et al. 2022.The effects of selective serotonin reuptake inhibitors on male and female fertility: a brief literature review. Int J Psychiatry Clin Pract. 26(1):43-49. 
  • Morales DR, et al. Antidepressant use during pregnancy and risk of autism spectrum disorder and attention deficit hyperactivity disorder: systematic review of observational studies and methodological considerations. BMC Med. 16:1–14.
  • Moses-Kolko, EL, et al. 2005. Neonatal signs after late in utero exposure to serotonin reuptake inhibitors:  Literature review and implications for clinical applications. JAMA 293:2372-2383.
  • Newport DJ, et al. 2002. The treatment of postpartum depression: Minimizing infant exposure. J Clin Psychiatry  63(Suppl 7): 31-44.
  • Rampono J, et al. 2006. Transfer of escitalopram and its metabolite demethylescitalopram into breastmilk. Br J Clin Pharmacol 3:316-22.
  • Reefhuis J, et al. 2015. Specific SSRIs and birth defects: bayesian analysis to interpret new data in the context of previous Bmj. 351:h3190.
  • Reis M and Kallen B. 2010. Delivery outcome after maternal use of antidepressant drugs in pregnancy: an update using Swedish data. Psychol Med 40(10):1723-1733. 
  • Sivojelezova A, et al. 2005. Citalopram use in pregnancy: prospective comparative evaluation of pregnancy and fetal outcome. Am J Obstet Gynecol 193:2004-9.
  • Sjaarda LA, et al. Urinary selective serotonin reuptake inhibitors across critical windows of pregnancy establishment: A prospective cohort study of fecundability and pregnancy loss. Fertil Steril 114:1278-1287.
  • Tabacova SA, et al. 2004. Adverse developmental events reported to FDS in association with maternal citalopram treatment in Birth Defects Res 70:361.
  • Wang S, et al. 2015. Selective serotonin reuptake inhibitors (SSRIs) and the risk of congenital heart defects: A meta-analysis of prospective cohort studies. Journal of the American Heart Association. 4(5).
  • Weissman AM, et al. 2004. Pooled analysis of antidepressant levels in lactating mothers, breast milk, and nursing infants. Am J Psychiatry. 161:1066-1078.

Diphenhydramine

Selected References:

  • Almas S, et al. 2016. Management of multiple sclerosis in the breastfeeding mother. Mult Scler Int:6527458. 
  • Amato MP and Portaccio E. 2015. Fertility, Pregnancy and Childbirth in Patients with Multiple Sclerosis: Impact of Disease-Modifying Drugs. CNS Drugs 29:207-220. 
  • Andersen JB, et al. 2018. Pregnancy outcomes in men and women treated with teriflunomide. A population-based nationwide Danish registry study. Frontiers in Immunology 9(2706):1-7.
  • Aubagio® Prescribing Information. 12/2022. Available online at http://products.sanofi.us/aubagio/aubagio.pdf, accessed 12/2022.  
  • Barataud-Reilhac A, et al. 2020. Teriflunomide-exposed pregnancies in French cohort of patients with multiple sclerosis. Neurol Clin Pract 10(4): 287-297.  
  • Cree BA. 2013. Update on reproductive safety of current and emerging disease-modifying therapies for multiple sclerosis. Mult Scler.19:835-43.  
  • Chambers CD, et al. 2010. Birth outcomes in pregnant women taking leflunomide. Arthritis Rheu. 62(5):1494-503. 
  • Chambers C, et al. 2007. Are new agents used to treat rheumatoid arthritis safe to take during pregnancy? Organization of Teratology Information Specialists (OTIS) study. Motherisk Update. 53(3):409-412. 
  • Cassina M, et al. 2012. Pregnancy outcome in women exposed to Leflunomide before or during pregnancy. Arth & Rheum 64(7):2085-2094. 
  • D’Aleo G, et al. 2020. Twin pregnancy outcome following teriflunomide treatment in a relapsing-remitting multiple sclerosis patient: A case report. Medicine (Baltimore) 99(28):e21212. 
  • Davenport L, et al. 2014. Teriflunomide: non-clinical evaluation demonstrates no effect on sperm DNA or male fertility [abstract]. Neurology 82(10 Supp):P2.233. 
  • De Santis M, et al. 2005. Paternal and maternal exposure to leflunomide: pregnancy and neonatal outcome. Ann Rheum Dis 64:1096-1097. 
  • Dobson R, et al. 2019. UK consensus on pregnancy in multiple sclerosis: ‘Association of British Neurologists’ guidelines. Pract Neurol. 19:106–14 
  • Gold R and Wolinsky JS. 2011. Pathophysiology of multiple sclerosis and the place of teriflunomide. Acta Neurol Scand 124(2):75-84. 
  • Henson LJ, et al. 2014. Updated pregnancy outcomes in patients and partners of patients in the terflunomide clinical trial program [abstract]. Neurology 82(10 Supp): P4.161. 
  • Kieseier B, et al. 2012. Pregnancy outcomes from the teriflunomide clinical development programme: retrospective analysis of the teriflunomide clinical trial database (Poster 737). Mult Scler;18(Suppl 4):328. 
  • Losee JE and Mason AC. 2005. Deformational plagiocephaly: diagnosis, prevention, and treatment. Clin Plastic Surg 31;53-64 
  • Lu E, et al. 2013. Safety of disease-modifying drugs for multiple sclerosis in pregnancy: current challenges and future considerations for effective pharmacovigilance. Expert Reviews 13(3):251-61. 
  • O’Connor P, et al. 2011: Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med 365(14):1293-1303.  
  • Varytė G, et al. 2021. Pregnancy and multiple sclerosis: an update. Curr Opin Obstet Gynecol 33(5):378-383. 
  • Vukusic  S, et al. 2020. Pregnancy outcomes in patients with multiple sclerosis treated with teriflunomide: Clinical study data and 5 years of post-marketing experience. Mult Scler 26(7):829-836.  
  • Weber-Schoendorfer C, et al. 2017. Leflunomide – A human teratogen? A still not answered question. An evaluation of the German Embryotox pharmacovigilance database. Reprod Toxicol 71:101-107. 

 

Diphenhydramine

Selected References:  

  • Bach V, et al. 1989. A randomized comparison between midazolam and thiopental for elective cesarean section anesthesia. III. Placental transfer and elimination in neonates. Anesth Analg. 68:238-42. 
  • Frolich MA, et al. 2006. A single dose of fentanyl and midazolam prior to Cesarean section have no adverse neonatal effects. Can J Anaesth. 53(1):79-85. 
  • Iyilikci L, et al. 2007. Sedation for endoscopic retrograde cholangiopancreatography (ERCP) in a pregnant patient. J Anesth. 21(1):69-71. 
  • Kanto J, et al. 1984. Pharmacokinetics and sedative effect of midazolam in connection with cesarean section performed under epidural analgesia. Acta Anaesthesiol Scand 28:116-8. 
  • Kelly LE, et al. 2012. Neonatal Benzodiazepines Exposure during Breastfeeding. J Pediatr. 161(3):448-451.
  • Koitabashi T, et al. 1997. Intravenous midazolam passage into breast milk. J Anesth. 11:242-3. 
  • Nitsun M, et al. 2006. Pharmacokinetics of midazolam, propofol, and fentanyl transfer to human breast milk. Clin Pharmacol 79:549-57. 
  • Olutoye OA, et al. 2018. Food and Drug Administration warning on anesthesia and brain development: implications for obstetric and fetal surgery. Am J Obstet 218(1):98-102.
  • Senel AC, et al. 2014. Premedication with midazolam prior to caesarean section has no neonatal adverse effects. Braz J Anesthesiol. 64(1):16-21. 
  • Shergill AK, et al. 2012. Guidelines for endoscopy in pregnant and lactating women. Gastrointest Endosc. 76(1):18-24. 
  • Swanson RJ, Leavitt MG. 1992. Fertilization and mouse embryo development in the presence of midazolam. Anesth Analg 75: 549-54, 1992. 
  • Uguz A New Safety Scoring System for the Use of Psychotropic Drugs During Lactation. Am J Ther. 2021 Jan-Feb 01;28(1):e118-e126. doi: 10.1097/MJT.0000000000000909. PMID: 30601177.
  • Wilson CM, et al. 1987. A comparison of the early pharmacokinetics of midazolam in pregnant and nonpregnant women. Anaesthesia. 42:1057-62. 
  • Xu J, et al 2019. Early Developmental Exposure to Repetitive Long Duration of Midazolam Sedation Causes Behavioral and Synaptic Alterations in a Rodent Model of Neurodevelopment. J Neurosurg Anesthesiol. 31(1):151- 
  • Young C, et al. 2005. Potential of ketamine and midazolam, individually or in combination, to induce apoptotic neurodegeneration in the infant mouse brain. Br J Pharmacol. 146(2):189-97.

Diphenhydramine

Selected References:

  • Holt RI, Peveler RC. 2011. Antipsychotics and hyperprolactinemia: mechanisms, consequences and management. Clin Endocrinol (Oxf). 74(2):141-7.
  • Einarson A, Boskovic R. 2009. Use and safety of antipsychotic drugs during pregnancy. J Psychiatr Pract. 15(3):183-92.
  • Loxitane® Product Label. Revised 2017. Available at URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017525s051,017658s038,018039s024lbl.pdf
  • Maguire GA. 2002. Prolactin elevation with antipsychotic medications: mechanisms of action and clinical consequences. J Clin Psychiatry. 63 Suppl 4:56-62.
  • Parikh T, et al. 2014. Antipsychotic drugs and safety concerns for breast-feeding infants. South Med J. 107(11):686-8.
  • Torre, DL, and Falorni, A. 2017. Pharmacological causes of hyperprolactinemia. Therapeutics and clinical risk management. 3(5): 929-51.
Diphenhydramine
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