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Metoclopramide During Early Pregnancy: How Safe?

In a large Israeli study, metoclopramide use during early pregnancy was not associated with excess risk for congenital malformations.

In the U.S., treatment of nausea and vomiting during early pregnancy usually involves pyridoxine (vitamin B₆) and antihistamines, such as doxylamine succinate, promethazine, or meclizine. If these agents are not effective, clinicians might turn to more-potent antiemetics, such as the dopamine antagonist metoclopramide. To assess the association between metoclopramide use during early pregnancy and risk for congenital malformations, investigators linked administrative records from an Israeli HMO with medical records from the hospital at which the insured women delivered. From 1998 to 2007, 81,703 singleton live births and 998 induced abortions occurred among participants (mean age, 28; two thirds Bedouin Muslim, one third Jewish).

Among women who had singleton births and induced abortions, 4.2% and 3.8%, respectively, received first-trimester metoclopramide. Among women who had singleton births and who were exposed to metoclopramide, the rate of major congenital malformations was 5.3%; among those who were not exposed, the rate was 4.9% (adjusted odds ratio, 1.04; 95% confidence interval, 0.89–1.21). Analyses that included pregnancy terminations yielded similar findings. Early exposure to metoclopramide also was not associated with significantly altered risk for minor or multiple congenital malformations; moreover, metoclopramide showed no dose-response effect.

Comment: Although metoclopramide is used more widely for treating women with nausea and vomiting during early pregnancy in Israel and some European countries than in the U.S., its use for this indication in the U.S. is not uncommon. Results of previous small studies have suggested that use during pregnancy is not linked to incidence of congenital anomalies. This large, retrospective cohort study provides substantial reassurance that metoclopramide does not cause congenital malformations. However, clinicians should be aware that use of this dopamine antagonist can cause maternal extrapyramidal symptoms (i.e., acute dystonic reactions and tardive dyskinesia).

— Andrew M. Kaunitz, MD

Published in Journal Watch Women's Health June 10, 2009

Citation(s):

Matok I et al. The safety of metoclopramide use in the first trimester of pregnancy. N Engl J Med 2009 Jun 11; 360:2528.

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• tardive dyskinesia
  Brenda J. Wentland, 10 Aug 2009 5:05 PM EST
  The fetus may be safe but there is the possibility the mother could suffer irreversible neurological changes.
  
  I am witnessing... [more]