FDA approves drug to fight nausea and vomiting

On April 8, 2013, the U.S. Food and Drug Administration approved the drug Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting.

More than half of all pregnant women have some nausea during the first trimester. For most women this nausea usually goes away by the second trimester. But for some women, nausea and vomiting may continue even past the first 12 weeks of pregnancy.

Diclegis is a delayed-release tablet intended for women who have not adequately responded to conservative management of nausea and vomiting during pregnancy, such as changes to their diet and lifestyle. These modifications include eating several small meals instead of three large meals, eating bland foods that are low in fat and easy to digest and avoiding smells that can trigger nausea.

“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,” said Dr. Hylton V. Joffe of the FDA’s Center for Drug Evaluation and Research. Observational studies have shown that the combination of active ingredients in Diclegis does not pose an increased risk of harm to a developing fetus.

For questions and answers about how drugs are approved by the FDA, click on this link.

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