
Teriflunomide
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.
Teriflunomide
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.
Teriflunomide
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.
Teriflunomide
Selected References:
- American College of Obstetricians and Gynecologists. Urinary tract infections in pregnant individuals. Clinical Consensus No. 4. Obstet Gynecol;142:435–45.
- Ailes EC, et al. 2018. Antibiotics dispensed to privately insured pregnant women with urinary tract infections – United States, 2014. MMWR Morb Mortal Wkly Rep, 67(1):18-22.
- Andersen JT et al. 2013. Trimethoprim use in early pregnancy and the risk of miscarriage: a register-based nationwide cohort study. Epidemiol Infect, 141:1749-1755.
- Cooper M, et al. 2014. Clinical Inquiry: how best to treat UTIs in women who breastfeed? J Fam Pract, 63(2):102-3.
- Crider KS, et al. 2009. Antibacterial medication use during pregnancy and risk of birth defects. Arch Pediatr Adolesc Med,163:978-985.
- Crowe HM, et al. 2021. Antibiotics and fecundability among female pregnancy planners: a prospective cohort study. Hum Reprod, 18;36(10):2761-2768.
- Czeizel AE, et al. 2001. The teratogenic risk of trimethoprim-sulfonamides: a population-based case-control study. Reprod Toxicol,15:637-646.
- Czeizel AE, et al. 2004. Possible association between different congenital abnormalities and use of different sulfonamides during pregnancy. Congenital Abnormalities, 44:79-86.
- Ford N, et al. 2014. Safety of co-trimoxazole in pregnancy: a systematic review and meta-analysis. J Acquir Immune Defic Syndr, 66(5): 512-521.
- Hansen C, et al. 2016. Trimethoprim-sulfonamide use during the first trimester of pregnancy and the risk of congenital anomalies. Pharmacoepidemiol Drug Saf, 25(2):170-8.
- Hernandez S, et al. 2000. Folic acid antagonists during pregnancy and the risk of birth defects. N Engl J Med, 343:1608-1614.
- Hernandez-Diaz S, et al. 2001. Neural tube defects in relation to use of folic acid antagonists during pregnancy. Am J Epidemiol, 153:961-968.
- Klarskov P et al. 2013. Short-acting sulfonamides near term and neonatal jaundice. Obstet Gynecol, 122:105-110.
- Li P, et al. 2020. Maternal exposure to sulfonamides and adverse pregnancy outcomes: A systematic review and meta-analysis. PLoS One, 15(12):e
- Molgaard-Nielsen D, Hviid A. 2012. Maternal use of antibiotics and the risk of orofacial clefts: a nationwide cohort Pharmacoepidemiol Drug Saf, 21:246-253.
- Murdia A, et al. 1978. Sulpha-trimethoprim combinations and male fertility. Lancet, 2:375-376.
- Muanda FT et al. 2018. Use of trimethoprim-sulfamethoxazole during pregnancy and risk of spontaneous abortion: a nested case control study. BJCP, 84(6):1198-1205.
- NIH-U.S. National Library of Medicine (2021). LABEL: BACTRIM DS- sulfamethoxazole and trimethoprim tablet. (nih.gov) Available at DailyMed https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm. Accessed November 14, 2024
- Santos F et al. 2011. Exposure to anti-infective drugs during pregnancy and the risk of small-for-gestational-age newborns: a case-control study. BJOG, 118:1374-1382.
- Wen SW, et al. 2008. Maternal exposure to folic acid antagonists and placenta-mediated adverse pregnancy outcomes. CMAJ, 179:1263-1268.
- Yang J et al. 2011. Exposure to trimethoprim/sulfamethoxazole but not other FDA category C and D anti-infectives is associated with increased risks of preterm birth and low birth weight. Int J Infect Dis, 15:e336- 341.
- Yu PA, et al. 2020. Safety of antimicrobials during pregnancy: a systematic review of antimicrobials considered for treatment and postexposure prophylaxis of p Clin Infect Dis, 70(70 Suppl 1):S37-S50.
Teriflunomide
Selected References:
- Bauer RL, et al. 2017. Use of transdermal selegiline in pregnancy and lactation: a case report. Psychosomatics, 58(4):450-452.
- Hagell P, et al. 1998. Pregnancy in Parkinson’s disease: a review of the literature and a case report. Mov Disord, 13(1):34-38.
- Kupsch A, Oertel WH. 1998. Selegiline, pregnancy, and Parkinson’s disease. Mov Disord, 13(1):175-176.
- Selegiline Drug Labels. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021479s010lbl.pdf and https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b891bd9f-fdb8-4862-89c5-ecdd700398a3&audience=consumer.
- Shimazu H, et al. 1995. [Study on oral administration of FPF 1100 prior to pregnancy, pregnancy, and lactation period in rats.] Yakuri To Chiryo, 23(1):57-70.
- Whitaker-Azmitia PM, et al. 1994. Effects of gestational exposure to monoamine oxidase inhibitors in rats: preliminary behavioral and neurochemical studies. Neuropsychopharmacology, 11(2):125-132.