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FDA Approves Diclegis for Pregnant Women Experiencing Morning Sickness
First drug for this indication in more than 30 years (Apr. 8)
The FDA has approved Diclegis (doxylamine succinate and pyridoxine hydrochloride [vitamin B6], Duchesnay USA) delayed-release tablets for the treatment of nausea and vomiting during pregnancy (NVP) in women who have not adequately responded to conservative management, such as dietary and lifestyle modifications. It is the first FDA-approved treatment for NVP — commonly known as morning sickness — in more than 30 years.
Diclegis was studied in 261 women experiencing NVP. The study participants were at least 18 years old and had been pregnant for 7 to 14 weeks. The women were randomly assigned to receive 2 weeks of treatment with Diclegis or placebo. Those taking Diclegis experienced greater improvement in nausea and vomiting than those taking placebo. In addition, observational (epidemiological) studies have shown that the combination of the active ingredients in Diclegis does not pose an increased risk of harm to the fetus.
Diclegis is taken daily. The 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 dosage of four tablets daily (one in the morning, one in mid-afternoon, and two at bedtime).
NVP usually improves after the first trimester. Health care professionals should reassess their patients for the continued need for Diclegis as pregnancy progresses.
Drowsiness or sleepiness, which can be severe, is the most common side effect reported by women taking the drug.
Diclegis is expected to be widely available in the U.S. by the end of May 2013.