The U.S. Food and Drug Administration has approved a drug to treat morning sickness in pregnant women experiencing nausea and vomiting.
Diclegis is a combination of doxylamine succinate and pyridoxine hydrochloride, or also known as Vitamin B6.
Diclegis was studied for safety and effectiveness in 261 women experiencing nausea and vomiting because of pregnancy. All the study participants were at least 18 years old and between weeks seven and 14 of pregnancy. Women taking the morning sickness drug in clinical studies experienced improvement in nausea and vomiting than did those taking a placebo pill, the FDA said in a press release.
“Many women experience nausea and vomiting during pregnancy, and sometimes these symptoms are not adequately managed through recommended changes in diet and lifestyle,” said Hylton V. Joffe, M.D., M.M.Sc., director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research. “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.”
The drug, Diclegis, marketed by Duchesnay Inc., based in Blainville, Québec, Canada, a private Canadian company, is a generic version of a product that was initially approved in the United States in 1956 under the name Bendectin. It was later withdrawn in 1983 following lawsuits from women claiming their children had been harmed by it.
Recently, in announcing the decision to approve the drug for the U.S. market, the FDA’s center for drug evaluation and research said the active ingredients in Diclegis do not pose any increased risk to a fetus.
The FDA says to take Diclegis daily. Diclectin comes in the form of a single pill and is only available with a prescription. 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.
The morning sickness drug does come with a risk of drowsiness or sleepiness that can be severe, which prompted the FDA to warn women taking the drug not to operate heavy machinery or to engage in activities that would require mental alertness.
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