SUNDAY, SEPTEMBER 25, 2016

Diclegis approved by FDA for pregnant women experiencing nausea and vomiting

The Food and Drug Administration approved Diclegis on Monday to treat women who are experiencing nausea and vomiting.

Diclegis, marketed by Duchesnay, Inc., is a delayed-release tablet made for women who have not properly responded to usual management of nausea and vomiting during pregnancy. These usual management techniques include dietary and lifestyle modifications, which would mean eating several smaller meals instead of three larger meals, eating bland foods low in fat and avoid smells that might cause nausea.

"Many women experience nausea and vomiting during pregnancy, and sometimes these symptoms are not adequately managed through recommended changes in diet and lifestyle," Hylton V. Joffe, director of the Division of Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research, said. "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 with nausea and vomiting due to their pregnancies. The study results showed women taking Diclegis had a better result when taking Diclegis over the placebo. It was also shown that the active ingredients in Diclegis do not pose an increased risk of harm to the fetus.