Diclegis (doxylamine succinate and pyridoxine hydrochloride) has been approved by the US Food and Drug Administration to treat nausea and vomiting during pregnancy.
The drug was sanctioned for pregnant women who haven’t responded to other therapies, such as eating smaller meals, eating lower-fat foods, and avoiding smells that can prompt nausea, the agency said in a media release.
Diclegis was evaluated in 261 adult women experiencing nausea and vomiting due to pregnancy who were at least 18 years of age and had been pregnant between 7 and 14 weeks. Women who took the drug had less nausea and vomiting than those who took a placebo. Studies also showed the drug didn’t pose a threat to the fetus, the FDA said.
The starting dose is two pills at bedtime, with an increase to a maximum recommended dose of four tablets daily (one in the morning, one mid-afternoon and two at bedtime) if symptoms are not adequately controlled. The most common side effect of the drug was potentially severe drowsiness. Women who take Diclegis should avoid driving or operating heavy machinery, the agency said.
The drug is marketed by the Canadian pharma firm Duchesnay, based in Quebec.
To read the FDA news release, click here.