HealthDay News — The FDA has approved doxylamine succinate and pyridoxine hydrochloride (Diclegis, Duchesnay) to treat nausea and vomiting during pregnancy.
The drug was sanctioned for pregnant women whose nausea has not responded to dietary modifications, including eating smaller meals, eating lower-fat foods and avoiding smells that may prompt nausea.
“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,” Hylton V. Joffe, MD, MMSc, director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.
The approval came after results from clinical trials involving 261 adult pregnant women experiencing nausea and vomiting showed those who took the drug experienced less nausea and vomiting than those who took a placebo. Additional observational studies have shown that the combination of the drugs active ingredients does not pose an increased risk of harm to the fetus.
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 doxylamine succinate and pyridoxine hydrochloride should avoid driving or operating heavy machinery, the agency said.