The U.S. Food and Drug Administration today approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting.
Diclegis is a delayed-release tablet intended for women who have not adequately responded to other ways of managing nausea and vomiting during pregnancy, such as dietary and lifestyle modifications.
“Many women experience nausea and vomiting during pregnancy, and sometimes these symptoms are not adequately managed through recommended changes in diet and lifestyle,” said Hylton V. Joffe, M.D., M.M.Sc., director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research. “Diclegis is now the only FDA-approved treatment for nausea and vomiting due to pregnancy, providing a therapeutic option for pregnant women seeking relief from these symptoms.”
Diclegis was studied in 261 women experiencing nausea and vomiting due to pregnancy. Study participants in the clinical trial were at least 18 years old and had been pregnant for at least 7 weeks and up to 14 weeks. Women were randomly assigned to receive two weeks of treatment with Diclegis or a placebo. The study results showed that women taking Diclegis experienced greater improvement in nausea and vomiting than those taking placebo. Additionally, observational (epidemiological) studies have shown that the combination of active ingredients in Diclegis does not pose an increased risk of harm to the unborn child.
Diclegis is taken daily. Tablets must be taken whole on an empty stomach. The recommended starting dose is two tablets taken at bedtime.
Nausea and vomiting due to pregnancy usually improve after the first trimester. Some women find that eating several small meals instead of three large meals, eating bland foods that are low in fat and easy to digest, and avoiding certain smells that can trigger nausea, reduce morning sickness.
Drowsiness or sleepiness, which can be severe, is the most common side effect reported by women taking Diclegis. Women should avoid using Diclegis when engaging in activities requiring mental alertness, such as driving or operating heavy machinery, until cleared to do so by their health care provider.
Dr. Ednun Anzian, ob-gyn in Lynbrook, NY, finds that extreme nausea can make “what should be a joyus time for the mother very miserable. Sometimes these moms are bedridden for a period of time and so this new medication will give them some relief.”
Diclegis is marketed by Duchesnay Inc., a Canadian company.