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Heartburn drugs deemed safe for fetuses according to Ben-Gurion University researchers
Date:10/7/2009

herapy exceed the risk to the fetus," according to the pediatrician and clinical pharmacologist, principal investigator Dr. Rafael Gorodischer, professor emeritus at Ben-Gurion University of the Negev. "Medicines are approved for use only after there is sufficient scientific evidence demonstrating the drug safety and effectiveness for its intended uses."

The safety of H2 blockers used 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 Southern District of Israel, with databases containing maternal and infant hospital records, and with therapeutic abortion records of Soroka University Medical Center, during the same period. In the study, 1,148 (or 1.4 percent) were exposed to H2 blockers during the first trimester of pregnancy of the 84,823 infants born to mothers during the study period.

The rate of major congenital malformations identified in the group that was exposed to H2 blockers during the first trimester was 5.7 percent (65 of 1,148 infants), as compared with a rate of 5.3 percent (4,400 of 83,675 infants) in the unexposed group.

According to principal investigator epidemiologist Dr. Amalia Levy of the BGU Faculty of Health Sciences, and chairwoman of the BeMORE collaboration, "Exposure to H2 blockers 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. Also, infants exposed in utero had no increased risk of perinatal mortality, low birth weight or premature birth".


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Contact: Andrew Lavin
andrewlavin@alavin.com
212-290-9540
American Associates, Ben-Gurion University of the Negev
Source:Eurekalert

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