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Doxylamine succinate-pyridoxine hydrochloride

April 1, 2021

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):817-31.
  • 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):23-6.
  • 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):842-5.
  • 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):337-49.
  • Einarson TR, et al. 1988. A method for meta-analysis of epidemiological studies. Drug Intell Clin Pharm 22:813-24.
  • Faraoni L, et al. 2020. Doxylamine use in pregnancy and neonatal abstinence syndrome: A case report. Reprod Toxicol 97:6.
  • 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.
  • 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.
  • 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 18;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 2015 (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.
  • Tyl RW, et al. 1988. Developmental toxicity evaluation of Bendectin in CD rats. Teratology 37:539-52.

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