FDA Approves “Morning Sickness” Medication

April 17, 2013
Jamie Habib

The FDA has approved Diclegis for the treatment of nausea and vomiting in pregnancy.

The FDA has approved Diclegis (doxylamine succinate, 10 mg, and pyridoxine hydrochloride, 10 mg) delayed-release tablets for the treatment of nausea and vomiting of pregnancy in women who do not adequately respond to conservative management.1 This is the only FDA-approved medication indicated specifically for nausea and vomiting caused by pregnancy. Diclegis is a combination of the common OTC sleep aid doxylamine succinate, which is an antihistamine, and pyridoxine hydrochloride, a form of vitamin B6.
   
The approval of Diclegis was based on a 15-day double-blind, randomized, multicenter, placebo-controlled trial involving 261 women with nausea and vomiting of pregnancy. All participants were 18 years or older with a gestational age between 7 weeks and 14 weeks. Symptom improvement was measured by changes in the pregnancy-unique quantification of emesis score. The study results showed that the women assigned to the Diclegis group had significantly greater improvement in the symptoms of nausea and vomiting compared with the women assigned to the placebo group.
   
Diclegis, which has pregnancy category A status, is intended for use only after conservative management strategies for nausea and vomiting have failed to produce adequate symptom improvement. These conservative strategies include eating 5 to 8 smaller meals a day instead of 3 larger meals, choosing low-fat bland foods that are easy to digest, and avoiding smells that can trigger nausea.
   
This medication is intended for daily use, and tablets must be taken whole and on an empty stomach. The recommended starting dose is 2 tablets taken orally at bedtime (day 1). If symptoms have not improved by the afternoon of day 2, the patient should take 2 tablets at bedtime, adding a third tablet the following morning (day 3). If symptoms persist on day 4, it is recommended that 1 tablet be taken in the morning, 1 tablet be taken mid-afternoon, and 2 tablets be taken at bedtime. The maximum recommended daily dose is 4 tablets.
   
After the first trimester, the need for Diclegis should be reassessed based on the patient’s symptoms. The most commonly reported adverse effect of Diclegis is drowsiness, which can be severe. Patients who take Diclegis should avoid driving until cleared to do so by a health care provider. In addition, women who are breastfeeding should discontinue the practice while taking Diclegis, because the antihistamine doxylamine will be present in the breast milk.

Pertinent Points:
- Diclegis (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg), available as delayed-release tablets, is the only FDA-approved medication currently available for the treatment of nausea and vomiting of pregnancy.
- Drowsiness and, subsequently, diminished mental alertness are the most commonly reported adverse effects; driving while taking Diclegis is not recommended.
- Breastfeeding should be discontinued in women who take Diclegis.
 

References:

1. U.S. Food and Drug Administration. FDA approves Diclegis for pregnant women experiencing nausea and vomiting. Available at:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm347087.htm

. Accessed April 9, 2013.
2. Duchesnay USA. FDA approves Duchesnay USA's Diclegis for treatment of nausea and vomiting of pregnancy (NVP) [press release]. Available at:

http://www.duchesnayusa.com/

. Accessed April 10, 2013.