FDA Approves Return of Drug after 30 Years to Treat Morning Sickness

A drug to treat morning sickness has made a comeback after 30 years. The U.S. Food and Drug Administration has given a nod to Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat pregnant women who are suffering from nausea and vomiting, according to a news release.

Marketed by Duchnesnay Inc., Diclegis is a drug that was pulled 30 years ago as it was linked to birth defects. The drug is consumed by women who have not shown positive response to the conservative management of nausea and vomiting during pregnancy. These practices include certain modifications in diet and lifestyle, such as eating several small meals instead of three large ones, consuming bland instead of spicy food in order to avoid smells that cause nausea, and consuming food that is low in fat.

"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," 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, said in a press statement.

The effect of the drug was studied on 261 women who were suffering from nausea and vomiting during pregnancy. The participants were at least 18 years old and had been pregnant for around 7-14 weeks. The participants received two weeks of treatment with Diclegis or a placebo.

The researchers noticed that those who took Diclegis had a greater improvement in nausea and vomiting than those who took the placebo.

On conducting an additional study, researchers showed that the combination of active ingredients in Diclegis did not trigger an increased threat to the growing fetus.

The drug can be consumed everyday on empty stomach. The dose is increased to four tablets daily if symptoms are not controlled.

The most common side-effect of this drug is severe drowsiness.