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April 10, 2013 Non-‐Profit Answers Questions About New Drug Aimed At Treating Nausea And Vomiting In Pregnancy; Experts Say The Drug May Help Curb Some Pregnancy Complications Brentwood, TN – As the U.S. Food and Drug Administration (FDA) announces approval of Diclegis (docylamine succinate and pyridoxine hydrochloride) to treat nausea and vomiting in pregnancy (NVP), MotherToBaby experts have begun fielding questions about the much-‐debated drug’s risks to a woman’s developing baby. Experts at MotherToBaby, the counseling service branch of the non-‐profit Organization of Teratology Information Specialists (OTIS), said NVP affects nearly 80% of pregnant women, usually in their first trimester. A smaller proportion of women develop hyperemesis gravidarum, a much more severe form of NVP. A pregnant woman who develops hyperemesis gravidarum, may potentially deliver a smaller baby. “Babies who are born at a lower birth weight can be predisposed to other complications,” explained Robert Felix, a senior teratogen information specialist for MotherToBaby’s California affiliate at the University of California, San Diego. “Diclegis might help to possibly curb that result.” However, the FDA’s decision to approve the drug did not happen overnight. The particular treatment has an extensive history associated with it. A similar drug, Bendectin, that was made available in the U.S. in 1956 for the treatment of NVP, became widely used by pregnant women, but was not well studied until nearly two decades later. Those studies failed to associate Bendectin with an increased risk for a pattern of major birth defects. Even with those results, the manufacturer voluntarily withdrew the drug from the U.S. market in 1983 over litigation based on unfounded concerns for birth defect risks. Sales, however, continued in the United Kingdom as Debendox and, more recently, as Diclectin in Canada. “We think we’ll get a lot of concerned calls about Diclegis,” said Felix. “We’d like to educate pregnant women and their providers about the efficacy of this drug for NVP because, generally, pregnant women do not seek treatment because their concern about safety,” he added. Felix referred to observational (epidemiological) studies that have shown the combination of active ingredients in Diclegis does not pose an increased risk of harm to the fetus. Also, a clinical trial of 261 women taking Diclegis to treat NVP showed the rate of birth defects did not differ between the women who took the drug versus those who took a placebo. In addition, the NVP symptoms among women taking the drug improved. Those with questions about Diclegis or other medications during pregnancy and breastfeeding are encouraged to call MotherToBaby experts toll-‐FREE at 866-‐626-‐6847 or by visiting MotherToBaby.org. MotherToBaby and OTIS, which are suggested resources by many agencies including the Centers for Disease Control and Prevention (CDC), are dedicated to providing
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