BLAINVILLE, QUEBEC – Diclegis (doxylamine succinate and pyridoxine hydrochloride) has been approved by the U.S. Food and Drug Administration to treat pregnant women experiencing nausea and vomiting.
It currently is the only approved treatment for those symptoms during pregnancy, the FDA said.
Diclegis is a delayed-release tablet intended for women who have not adequately responded to conservative management of so-called morning sickness during pregnancy, such as dietary and lifestyle modifications.
“Study results showed that women taking Diclegis experienced greater improvement in nausea and vomiting than those taking placebo,” according to the FDA, which pointed out that epidemiological studies have shown that the combination of active ingredients in Diclegis does not pose an increased risk of harm to the fetus.
A similar drug called Bendectin was pulled off of drugstore shelves 30 years ago because of concerns of harm to unborn babies, but more recent studies suggested those fears were unfounded.
Diclegis is marketed by Duchesnay Inc., based in Blainville, Québec, Canada.