Metoclopramide during pregnancy not associated with birth defects or fetal death

Image: PD 

1. Metoclopramide use in pregnancy was neither significantly associated with increased risk of major malformations overall nor increased risk of 20 different individual malformation categories.

2. Metoclopramide use in pregnancy was also not significantly associated with spontaneous abortion or stillbirth. 

Evidence Rating Level: 2 (Good) 

Study Rundown: While most pregnancy-related nausea and vomiting can be treated using conservative measures, there is a small subset of women that require further medical management. Metoclopramide is consequently one of the most commonly utilized prescription medications during pregnancy. While previous studies have shown no association between metoclopramide use and the overall number of major malformations, none have examined the risk of individual malformation categories or fetal death. In this study, metoclopramide use in pregnancy was neither significantly associated with increased risk of major malformations nor increased risk of 20 different individual malformation categories. By examining metoclopramide use in terms of different individual malformation categories, the study further reassures prescribers on the safety profile of this medication. Similarly, metoclopramide use in pregnancy was also not significantly associated with spontaneous abortion or stillbirth.

Although the authors examined an impressive number of pregnancies (> 1 million), the study design may have inherently introduced bias based on its assumption that filling of prescriptions equated use of the prescribed medication. Nevertheless, at this time, the study supports the notion that metoclopramide appears to be safe for use during pregnancy.

Click to read the study, published today in JAMA

Relevant Reading: Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects

In-Depth [retrospective cohort study]: Using data obtained from nationwide registers, this cohort study examined 1,222,503 pregnancies in Denmark over a thirteen year period and matched metoclopramide-exposed and unexposed women based on metoclopramide prescription fill rates. These two groups were compared to determine the risk of major fetal malformations overall, 20 individual malformation categories, spontaneous abortion and stillbirth as primary outcomes. Secondary outcomes of preterm birth, low birth weight, and small for gestational age (SGA) were also compared across the two groups. The study found no significant association between metoclopramide use and malformations overall (odds ratio, 0.93[95% CI, 0.86-1.02]) and in 20 individual malformation categories, spontaneous abortion (hazard ratio, 0.35[95% CI, 0.33-0.38]) and stillbirth (hazard ratio, 0.90[95% CI, 0.74-1.08]). There were no significant outcomes between metoclopramide use and preterm birth, low birth weight, and SGA.

By Priyanka Vedak and Rif Rahman

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