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FDA Approves First Treatment for Morning Sickness

April 23, 2013

The U.S. Food and Drug Administration approved Diclegis to treat pregnant women experiencing severe morning sickness, officials say.

Conservative management of "morning sickness" includes dividing up big meals into smaller ones, eating low-fat bland foods that are easy to digest, and avoiding smells that trigger nausea. Often, however, these nonmedical measures are not enough, said Hylton Joffe, MD, 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."

Study participants in the clinical trial were at least age 18 and had been pregnant for at least seven 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 pregnant women taking Diclegis experienced greater improvement in nausea and vomiting than those taking the placebo.

Additionally, observational studies showed the combination of active ingredients in Diclegis does not pose an increased risk of harm to the fetus, Joffe said.

The FDA recommends a starting dose every day at bedtime and on an empty stomach. The dose can be boosted to a maximum of 4 doses per day — one in the morning, one in midafternoon, and 2 at bedtime — if need be.

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