Diclegis Becomes First-Ever Approved Morning Sickness Drug — What You Need to Know

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Great news for women suffering from morning sickness during their pregnancies! The FDA has officially approved the drug Diclegis.

The drug, which taken daily, must be taken whole on an empty stomach. Women new to the drug are only recommended to take two tablets at bedtime — but can take up to four tablets daily: once in the morning, once mid-afternoon and twice at bedtime.

Hylton V. Joffe, director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research, said, “Many women experience nausea and vomiting during pregnancy and sometimes these symptoms are not adequately managed through recommended changes in diet and lifestyle. Diclegis is now the only FDA-approved treatment for nausea and vomited due to pregnancy, providing a therapeutic option for pregnant women seeking relief from these symptoms.

Prior to its FDA approval, Diclegis given to 261 women experiencing nausea and vomiting due to their pregnancies. The women had all been pregnant for at least seven weeks and up to 14 weeks. Each woman was randomly assigned two weeks of treatment with either Diclegis or a placebo drug. From the results, researchers gathered that the women taking Diclegis experienced a greater improvement in their nausea and vomiting than those who were given the placebo drug. What’s more, observational studies have shown that the combination of active ingredients in Diclegis are save for the fetus and pose no harm.

Did you take Diclegis?

Plus, more from The Bump:

Is Zofran Safe for Pregnant Women?

How to Deal With Morning Sickness

What Medications are Safe During Pregnancy?