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Metoclopramide not linked with major congenital malformations


A clinical research study has suggested that metoclopramide was not linked with major congenital malformations, stillbirth and spontaneous abortions. The study was published in JAMA.


The present study has assessed over 40, 000 pregnant women who were exposed to metoclopramide.

Metoclopramide is generally prescribed for the management of nausea or vomiting during pregnancy. Metoclopramide is prescribed only if other treatment options such as vitamin B6 or antihistamine are ineffective. Existing safety data of metoclopramide during pregnancy are limited.


The association between maternal metoclopramide use and serious adverse events were assessed by a team of researchers guided by Dr. Bjorn Pasternak, Statens Serum Institute, Denmark. The study included about 1,222,503 Danish pregnant women. The study period was between 1997 and 2011. The study compared the adverse events between maternal metoclopramide (first-trimester) users with the non-users.


After dropping-out excluding criteria, the metoclopramide exposed women gave birth to 28, 486 live-born infants, and the control group gave birth to 113, 698 unexposed infants. Clinically significant congenital malformation during the first year of birth was observed in about 721 exposed and 3024 unexposed infants.


No associations between first-trimester metoclopramide use and 20 malformations including limb reductions, neural tube defects, cleft lip and cleft palate. No increased risk of stillbirth, low birth weight, fetal growth retardation, pre-term birth and spontaneous abortions are associated with metoclopramide use.


The present study can help the clinicians to make informed decision before prescribing metoclopramide to pregant women, the authors wrote in the publication.

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