Although metoclopramide is a popular antiemetic drug for pregnant women, data regarding its safety are lacking, Dr. Rafael Gorodischer, from Soroka Medical Center, Beer-Sheva, Israel, and colleagues note. The few studies that have examined this topic have been small and, therefore, have been unable to reach definitive conclusions.
The present study, reported in The New England Journal of Medicine for June 11, analyzed data on 81,703 singleton births that occurred among women registered in the Clalit Health Services, southern district of Israel, from January 1998 to March 2007.
Overall, 4.2% of the infants were exposed to metoclopramide during the first trimester of pregnancy, the researchers report.
Exposure to metoclopramide, relative to non-exposure to the drug, did not significantly affect the risks of major congenital malformations (5.3% vs. 4.9%), low birth weight (8.5% vs. 8.3%), preterm delivery (6.3% vs. 5.9%), or perinatal death (1.5% vs. 2.2%).
The null findings were still apparent even when therapeutic abortions of exposed and unexposed fetuses were included in the analysis, the researchers note.
"In this large, population-based cohort, we found no significant association between metoclopramide treatment in the first trimester and adverse outcomes for the fetus, including congenital malformations, perinatal death, low birth weight, and low Apgar scores," the authors conclude.
N Engl J Med 2009;360:2528-2535.
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