The FDA ( Food and Drug Administration ) has approved Diclegis ( Doxylamine and Pyridoxine ) to treat pregnant women experiencing nausea and vomiting.

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 dietary and lifestyle modifications. 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 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 studies have shown that the combination of active ingredients in Diclegis does not pose an increased risk of harm to the fetus.

Diclegis is taken daily. Tablets must be taken whole on an empty stomach. The recommended starting dose is two tablets taken at bedtime. If symptoms are not adequately controlled, the dose can be increased to a maximum recommended dose of four tablets daily ( one in the morning, one mid-afternoon and two at bedtime ).

Nausea and vomiting due to pregnancy usually improve after the first trimester. Health care professionals should reassess their patients for continued need for Diclegis as pregnancy progresses.

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.

Source: FDA, 2013

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