Off-label morning sickness drug deemed safe for fetuses

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. 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.

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.

Bonnie - this is what they said about Thalidomide until babies were born without limbs. I would not want any pregnant woman to be a guinea pig for an off-label drug.