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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Authors | Gideon Koren |
Journal | Journal of population therapeutics and clinical pharmacology = Journal de la therapeutique des populations et de la pharmacologie clinique
(J Popul Ther Clin Pharmacol)
Vol. 20
Issue 2
Pg. e161-2
( 2013)
ISSN: 2561-8741 [Electronic] Australia |
PMID | 23863487
(Publication Type: Journal Article)
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Chemical References |
- Antiemetics
- Delayed-Action Preparations
- Drug Combinations
- dicyclomine, doxylamine, pyridoxine drug combination
- Dicyclomine
- Doxylamine
- Pyridoxine
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Topics |
- Antiemetics
(adverse effects, therapeutic use)
- Delayed-Action Preparations
- Dicyclomine
- Doxylamine
(adverse effects, therapeutic use)
- Drug Approval
- Drug Combinations
- Drug Labeling
- Female
- Humans
- Morning Sickness
(drug therapy, epidemiology)
- Pregnancy
- Pyridoxine
(adverse effects, therapeutic use)
- United States
- United States Food and Drug Administration
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