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Home | Pregnancy Timeline | News Alerts |News Archive Nov 1, 2013

 

The care of most women is managed conservatively, but 10 percent to 15 percent of those with nausea and vomiting in early pregnancy will eventually receive drug treatment. Metoclopramide is often recommended if treatment with an antihistamine or vitamin B6 has failed.







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Nausea medication for pregnancy does not increase risk of malformations

In an analysis that included more than 40,000 women exposed to the nausea medication metoclopramide in pregnancy, the drug was not associated with significantly increased risk of major congenital malformations overall, spontaneous abortion, or stillbirth.

The study is published in the October 16 issue of JAMA.

More than 50 percent of pregnant women experience nausea and vomiting, typically early in their pregnancy. The care of most women is managed conservatively, but 10 percent to 15 percent of those with nausea and vomiting will eventually receive drug treatment. Metoclopramide is often recommended if treatment with an antihistamine or vitamin B6 has failed. Despite metoclopramide being one of the most commonly used prescription medications in pregnancy, data on the safety of its use in pregnancy are limited, according to background information in the article.

Bjorn Pasternak, M.D., Ph.D., of the Statens Serum Institut, Copenhagen, and colleagues conducted a study to investigate associations between metoclopramide use in pregnancy and serious adverse outcomes. The study included 1,222,503 pregnancies in Denmark from 1997-2011 and compared outcomes for women who used metoclopramide to those who did not.

In a group that included women exposed and unexposed (control group) to metoclopramide, there were 28,486 live-born infants exposed to metoclopramide in the first trimester of pregnancy and 113,698 unexposed infants. Of these, 721 exposed (25.3 per 1,000 births) and 3,024 unexposed infants (26.6 per 1,000 births) were diagnosed with any major malformation during the first year of life.


In analyses of individual malformation categories, there were no associations between metoclopramide use in the first trimester and any of the 20 malformations, including neural tube defects, cleft lip, cleft palate and limb reduction.


The researchers also observed no increased risk of spontaneous abortion, stillbirth, preterm birth, low birth weight, and fetal growth restriction associated with metoclopramide use in pregnancy.

"These safety data may help inform decision making when treatment with metoclopramide is considered in pregnancy," the authors conclude.

Abstract
Importance Metoclopramide, a drug frequently used for nausea and vomiting in pregnancy, is thought to be safe, but information on the risk of specific malformations and fetal death is lacking.

Objective To investigate the safety of metoclopramide use in pregnancy.

Design, Setting, and Participants Register-based cohort study in Denmark, 1997-2011. From a cohort of 1 222 503 pregnancies, metoclopramide-exposed and unexposed women were matched (1:4 ratio) on the basis of age, calendar year, and propensity scores.

Main Outcomes and Measures
Primary outcomes were major congenital malformations overall, 20 individual malformation categories (selected according to power criteria), spontaneous abortion, and stillbirth. In matched analyses, logistic regression was used to estimate prevalence odds ratios of malformations and Cox regression to estimate hazard ratios (HRs) of spontaneous abortion.

Results
Among 28 486 women exposed to metoclopramide in the first trimester, 721 had an infant with a major congenital malformation (25.3 [95% CI, 23.5-27.1] cases per 1000 births), compared with 3024 among 113 698 unexposed women (26.6 [95% CI, 25.7-27.5] per 1000 births). There were no significant associations between metoclopramide use and malformations overall (prevalence odds ratio, 0.93 [95% CI, 0.86-1.02]) or any of the 20 individual malformation categories, eg, neural tube defects, transposition of great vessels, ventricular septal defect, atrial septal defect, tetralogy of Fallot, coarctation of the aorta, cleft lip, cleft palate, anorectal atresia/stenosis, and limb reduction (upper limit of 95% CI below 2.0 for 17 of 20 categories). Metoclopramide was not associated with increased risk of spontaneous abortion (757 cases [20.0 {95% CI, 18.5-21.4} per 1000] among 37 946 metoclopramide-exposed women and 9414 cases [62.1 {95% CI, 60.9-63.3} per 1000] among 151 661 unexposed women; HR, 0.35 [95% CI, 0.33-0.38]) and stillbirth (142 cases [3.5 {95% CI, 2.9-4.1} per 1000] among 40 306 metoclopramide-exposed women and 634 cases [3.9 {95% CI, 3.6-4.2} per 1000] among 161 098 unexposed women; HR, 0.90 [95% CI, 0.74-1.08]).

Conclusions and Relevance
Metoclopramide use in pregnancy was not associated with increased risk of major congenital malformations overall, any of the 20 individual malformation categories assessed, spontaneous abortion, or stillbirth. These safety data may help inform decision making when treatment with metoclopramide is considered in pregnancy.

(doi:10.l001/jama.2013.278343; Available pre-embargo to the media at http://media.jamanetwork.com)

Editor's Note: This study was supported by a Danish Medical Research Council grant. All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

Please Note: An author podcast on this study will be available post-embargo on the JAMA website.

Original press release:http://www.eurekalert.org/pub_releases/2013-10/tjnj-mtf101013.php

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