In case you are among the expecting mothers who consume H2 Blocker drugs for acid reflux, here’s some good news. You may not have to completely give up taking those drugs as experts from Ben-Gurion University of the Negev claim that these drugs seem to have no considerable risks for the fetus. These H2 Blocker drugs are known to include Famotidine, Cimetidine and Ranitidine which are approved in the U.S.
Apparently, this study provides significant support for the safety of the fetus when H2 blocker drugs are given to women in order to relieve acid reflux during pregnancy. H2 blockers are among the most commonly recommended drugs for acid reflux symptoms of heartburn, regurgitation and trouble swallowing, which appear to be widespread in pregnant women. Generally, symptoms of acid reflux appear to be more frequent and more serious in the latter months of gestation. It was estimated that nearly 30 percent to 80 percent of pregnant women are affected by it.
The study was noted to have examined infants born to mothers who were exposed to H2 blockers, mainly Famotidine at the time of pregnancy. During the study, approximately 1,148 i.e. 1.4 percent were observed to have been exposed to H2 blockers during the first trimester of pregnancy of the 84,823 infants born to mothers during the study period.
Evidently, the study was collaborated 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. Moreover, this study seems to have been conducted by the three Israeli entities as part of the BeMORE collaboration (Ben-Gurion MotheRisk Obstetric Registry of Exposure).
Chief author of the study, pediatrician and clinical pharmacologist, Dr. Rafael Gorodischer, professor emeritus at Ben-Gurion University of the Negev stated that, “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,” continues Gorodischer.
The safety of H2 blockers used during the first trimester of pregnancy seems to have been examined by connecting a database of medicines distributed over 10 years to all women registered in Clalit Health Services in the Southern District of Israel. Clalit Health Services were believed to have databases including maternal and infant hospital records along with therapeutic abortion records of Soroka University Medical Center during the same period.
“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,” says principal investigator epidemiologist Dr. Amalia Levy of the BGU Faculty of Health Sciences, and chairwoman of the BeMORE collaboration.
The findings revealed that the rate of major congenital malformations identified in the group which was exposed to H2 blockers during the first trimester appears to be 5.7 percent i.e. 65 of 1,148 infants in contrast to the rate of 5.3 percent i.e. 4,400 of 83,675 infants in the unexposed group.
Supposedly, the analysis of the safety of other medicines commonly used off-label in pregnancy is a current project of BeMORE investigators in large cohorts of women in Southern Israel.
The findings of the study have been published in The Journal of Clinical Pharmacology.