Diclegis is a delayed-release tablet intended for women who have not adequately responded to conservative management of nausea and vomiting during pregnancy, such as dietary and lifestyle modifications. These modifications include eating several small meals instead of three large meals, eating bland foods that are low in fat and easy to digest and avoiding smells that can trigger nausea.
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.”
Diclegis is taken daily. 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).
Allison Taylor, MD, an OB/GYN with the Center for Women’s Health, commented on the new medication:
This medication is not really new at all. It’s a combination of doxylamine (an antihistamine) and vitamin B6 that was previously known as Bendectin and used for the treatment of hyperemesis gravidarum in the 1970s and early 90s. In 1983, the manufacturer of Bendectin voluntarily removed it from the market because of concerns about possible birth defects. Multiple studies, however, have subsequently confirmed the medication as being safe for pregnancy. It’s very exciting for both pregnant patients and the physicians who take care of them to have another option for management of this bothersome side-effect of pregnancy.