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

Levy of the BGU Faculty of Health Sciences, and chairwoman of the BeMORE collaboration, "of the vast majority of medications approved for use, there is insufficient data from human studies to determine whether the benefits of therapy exceed the risk to the fetus. Medicines are approved for use only after there is sufficient scientific evidence demonstrating the drug safety and effectiveness for its intended uses. There is extensive experience with the use of this medication in non-pregnant persons, with evidence of overall low rates of adverse effects when it is used as recommended."

The safety of metoclopramide use during the first trimester of pregnancy was investigated by linking a database of medications dispensed over 10 years to all women registered in Clalit Health Services in the Sothern District of Israel, with databases containing maternal and infant hospital records of Soroka University Medical Center, during the same period. In the study, 3,458 (or 4.2 percent) were exposed to metoclopramide during the first trimester of pregnancy of the 81,703 infants born to mothers during the study period.

The rate of major congenital malformations identified in the group that was exposed to metoclopramide during the first trimester was 5.3 percent% (182 of 3458 infants), as compared with a rate of 4.9 percent (3834 of 78,245 infants).

As a result, exposure to metoclopramide among this group was not associated with significantly increased risks of major congenital malformations. The results were unchanged when therapeutic abortions of exposed fetuses were included in the analysis. In addition, infants exposed in utero had no increased risk of perinatal mortality, low birth weight or premature birth.

Data of this study support the labeling of metoclopramide for nausea and vomiting during pregnancy.


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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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