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

Gideon Koren

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.

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