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Off-label morning sickness drug deemed safe for fetuses -- Ben-Gurion U. researchers
Date:6/10/2009

BEER-SHEVA, ISRAEL, June 10, 2009 Metoclopramide, a drug approved in the U.S. for nausea, vomiting and heartburn poses no significant risks for the fetus according to a large cohort study published in the June 11 issue of the prestigious New England Journal of Medicine, "The Safety of Metoclopramide Use in the First Trimester of Pregnancy" (N Engl J Med 2009;360:24 June 11, 2009).

According to the pediatrician and clinical pharmacologist, principal investigator Dr. Rafael Gorodischer, prof. emeritus at Ben-Gurion University of the Negev, "Metoclopramide is the drug of choice in Europe and Israel for "morning sickness-like" symptoms of nausea and vomiting, which are common in pregnant women. In the U.S. however, it is only used in the most severe cases, as it is an "off-label" use for nausea and vomiting during pregnancy. The findings of this very large cohort study examining infants born to mothers who were exposed to metoclopramide during the first trimester provide significant reassurance for the safety of the fetus when the drug is given to women to relieve nausea and vomiting during pregnancy."

Between 50 percent to 80 percent of pregnant women experience nausea and vomiting during the first trimester and beyond, which can be severe.

This study is collaboration between Ben-Gurion University of the Negev, Soroka University Medical Center and Clalit Health Services -- all in Beer-Sheva, Israel -- along with the Division of Pharmacology, Hospital for Sick Children in Toronto, Canada. The study is part of the doctoral thesis of Ilan Matok and was conducted by the three Israeli entities as part of the BeMORE collaboration (Ben-Gurion MotheRisk Obstetric Registry of Exposure). The study of the safety of other medications commonly used off-label in pregnancy is an ongoing project of BeMORE investigators in large cohorts of women in Southern Israel.

According to principal investigator epidemiologist Dr. Amalia
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Contact: Andrew Lavin
alc@alavin.com
516-353-2505
American Associates, Ben-Gurion University of the Negev
Source:Eurekalert

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