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Diclegis® for Nausea and Vomiting of Pregnancy

Darrell Hulisz, RPh, PharmD
Elizabeth Hohner

April 30, 2013

The FDA recently approved Diclegis® (delayed-release doxylamine 10mg plus pyridoxine 10mg) to treat nausea and vomiting of pregnancy (NVP) in the United States.1 The same drug combination was previously marketed in the US for morning sickness as Bendectin. However, it was voluntarily removed from the market in 1983 after numerous lawsuits alleging birth defects, which have since been dismissed. The withdrawal from market stemmed from the legal costs to the manufacturer to defend the product. This same delayed-release drug combination has been marketed in Canada as Diclectin® since 1979. Over the past 30 years, the safety and efficacy of doxylamine and pyridoxine in pregnancy has been confirmed.

A recent randomized, placebo-controlled trial demonstrated both the safety and efficacy of this combination in pregnancy. The study population consisted of pregnant women who were at least 18 years old and 7-14 weeks gestational age, had NVP resulting in significant impact on daily living and had inadequate response to conservative management with diet and lifestyle modifications. Patients took two tablets at bedtime and if needed could increase the dose by one tablet in the morning and/or afternoon if symptoms persisted. The maximum studied dose was four tablets per day. The study period was 15 days; however, adverse effects were followed after termination of the study in patients who chose to continue the drug for compassionate use. Compared to placebo, Diclegis® resulted in significantly greater improvement in symptoms of NVP. Additionally there was no increased incidence of adverse events associated with Diclegis®. Diclegis ® is a prescription product intended for women who have failed to respond to conservative management of NVP, which includes eating smaller more frequent meals, eating bland foods which are low in fat and avoiding smells known to trigger nausea. The drug is FDA pregnancy category A.

FDA. FDA approves Diclegis for pregnant women experiencing nausea and vomiting. April 8, 2013. FDA News Release. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm347087.htm

Koren G, Clark S, Hankins GDV, Caritis SN, Miodovnik M, Umans JG, et al. Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial. Am J Obstet Gynecol 2010; 203:571.e1-7.

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