title: The return to the USA of doxylamine-pyridoxine delayed release combination (Diclegis®) for morning sickness--a new morning for American women.
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.
authors.affiliation: Motherisk Program, Department of Pediatrics, The Hospital for Sick Children, and the University of Toronto, Toronto, Canada. gkoren@sickkids.ca
authors.forename: Gideon
authors.initials: G
authors.lastname: Koren
mesh_terms: D000932:Antiemetics / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004025:Dicyclomine; D004319:Doxylamine / Q000009:adverse effects / Q000627:therapeutic use*; D017277:Drug Approval; D004338:Drug Combinations; D004348:Drug Labeling; D005260:Female; D006801:Humans; D048968:Morning Sickness / Q000188:drug therapy* / Q000453:epidemiology; D011247:Pregnancy; D011736:Pyridoxine / Q000009:adverse effects / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000932:Antiemetics; D003692:Delayed-Action Preparations; D004338:Drug Combinations; C004454:dicyclomine, doxylamine, pyridoxine drug combination; D004025:Dicyclomine; D004319:Doxylamine; D011736:Pyridoxine