THE RETURN TO THE USA OF THE DOXYLAMINE-PYRIDOXINE DELAYED RELEASE COMBINATION (DICLEGIS®) FOR MORNING SICKNESS - A NEW MORNING FOR AMERICAN WOMEN
Main Article Content
Keywords
Nausea, vomiting, pregnancy, NVP, doxylamine, pyridoxine, diclegis, diclectin, bendectin, Canada, USA
Abstract
The US FDA approval in April 2013 of Diclegis®, the doxylamine-pyridoxine combination for morning sickness, is a major milestone, particularly since it is indicated for use in pregnancy and the FDA has labeled it a pregnancy category A drug the strongest evidence of fetal safety. After thirty years of being orphaned from an FDA- labeled drug for the most common medical condition in pregnancy, American women and their health care providers have a therapeutic solution that is likely to positively impact millions of women each year. This review highlights the milestones of this antiemetic agent over the last 40 years.
References
2. Einarson TR, Leeder JS, Koren G. A method for meta-analysis of epidemiological studies. Drug Intell Clin Pharm 1988;22:813-24.
3. McKeigue PM, Lamm SH, Linn S, Kutcher JS. Bendectin and birth defects: I. A meta-analysis of the epidemiologic studies. Teratology 1994;50:27-37.
4. Nulman I, Rovet J, Barrera M, Knittel-Keren D, Feldman BM, Koren G. Long-term neurodevelopment of children exposed to maternal nausea and vomiting of pregnancy and diclectin. J Pediatr 2009;155:45-50, 50.e1-2.
5. Koren G, Clark S, Hankins GD, Caritis SN, Miodovnik M, Umans JG, Mattison DR. Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial. Am J Obstet Gynecol 2010;Dec;203(6):571.e1-7.doi: 10.1016/j.ajog.2010.07.030.
6. Atanackovic G, Navioz Y, Moretti ME, Koren G. The safety of higher than standard dose of doxylamine-pyridoxine (Diclectin) for nausea and vomiting of pregnancy. J Clin Pharmacol 2001 Aug; 41(8):842-5.