Diclegis (doxylamine succinate and pyridoxine hydrochloride) has just been approved by the U.S. Food and Drug Administration (FDA) for the treatment of nausea and vomiting, commonly known as “morning sickness”, among pregnant women.
The drug, marketed by Duchesnay Inc., based in Blainville, Québec, Canada, is intended to be used when women don’t respond to dietary and lifestyle modifications, such as eating several smaller meals and avoiding smells that can trigger nausea. Sometimes these measures aren’t enough to prevent vomiting and nausea.
Half of all pregnant mothers suffer from morning sickness. Some recommended measures to avoid morning sickness include getting plenty of rest, avoiding fatty foods, being physically active and staying hydrated.
The director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research, Hylton V. Joffe, M.D., M.M.Sc., said:
“Many women experience nausea and vomiting during pregnancy, and sometimes these symptoms are not adequately managed through recommended changes in diet and lifestyle. 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.”
In the 1980s the drug was available under the name Bendectin. However, following a series of lawsuits that linked the drug with birth defects, it was removed from the U.S. market.
The FDA’s center for drug evaluation and research evaluated the effectiveness of the drug among 261 women (at least 18 years old) who experienced vomiting and nausea during their 7th and 14th week of pregnancy. The participants were either given two weeks of treatment with either Diclegis or a placebo.
The results of the study showed that the pregnant mothers who took Diclegis experienced far less nausea and vomiting compared to those who were on placebo.
Observational studies have shown that there are no active ingredients in Diclegis that can potentially harm the fetus.
Diclegis should be taken daily on an empty stomach at a starting dose of two tablets just before going to sleep. If the symptoms do not appear to improve with two tablets per day the dose can be increased to four.
Usually, symptoms of nausea and vomiting improve after the first trimester of pregnancy. However, doctors should always monitor their patients and assess whether or not they should take Diclegis to help lessen bothersome symptoms.
The side effects of the drug include drowsiness and sleepiness, which can impair mental alertness. Therefore, the FDA recommends that women on the medication refrain from operating or driving heavy machinery without guidance by their health care provider.
Written by Joseph Nordqvist