FDA Approves Morning Sickness Drug

April 12, 2013

After more than 30 years, the FDA re-approves use of medication for pregnant women for whom conservative management of nausea and vomiting (eg, changes in diet and lifestyle) is ineffective.

The FDA has approved the use of doxylamine succinate and pyridoxine hydrochloride (Diclegis) for the treatment of nausea or vomiting during pregnancy. The medication, originally called Bendectin, was pulled off the market decades ago because of safety concerns.

This approval was based on a study of 261 women who were experiencing nausea and vomiting during weeks 7 through 14 of their pregnancy. Compared with placebo, Diclegis resulted in significantly dimished nausea and vomiting. No safety concerns were noted in the approval: the most commonly reported adverse effect was drowsiness or sleepiness.

A press release from the FDA notes that this therapy is indicated for women for whom conservative management of nausea and vomiting (eg, changes in diet and lifestyle) is ineffective. Such measures include eating several small portions of bland, low-fat foods instead of 3 large meals and avoiding smells that can trigger nausea.

Diclegis, a delayed-release tablet, is taken before the onset of symptoms, typically at bedtime. The recommended starting dose is 2 tablets. Clinicians are encouraged to reassess pregnant women periodically to determine the need for continued administration of Diclegis.