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MotherToBaby

Medications and More during pregnancy and breastfeeding

Doxylamine succinate-pyridoxine hydrochloride

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.

 

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