HealthDay News — Use of the nausea drug metoclopramide (Reglan) during pregnancy is not associated with an increased risk of birth defects, spontaneous abortion or stillbirth, study findings indicate.
Among women who used metoclopramide to relieve nausea and vomiting in the first trimester, there were no significant differences seen in the occurrence of major congenital malformations in their children and those born to moms who did not take the drugs (25.3 vs. 26.6 per 1,000 births; prevalence OR 0.93; 95% CI: 0.86-1.02), Björn Pasternak, MD, PhD, from the Statens Serum Institut in Copenhagen, Denmark, and colleagues wrote in Journal of the American Medical Association.
In addition, the researchers found no significant associations between the drug and any of 20 individual malformation categories, including neural tube defects, transposition of the great vessels, ventricular septal defect, limb reduction and cleft lip/palate.
However, there were three congenital malformations in which the upper limits of the confidence intervals were below 2.6, meaning they could not be ruled out with a high degree of certainty. These three defects were congenital skin disorders, coarctation of aorta and tetralogy of Fallot.
These findings are similar to those from a 2009 JAMA study that involved 3,400 women who were exposed to metoclopramide during the first trimester, in which no birth defects were associated with the drug, nor were there associations with low birth weight, preterm delivery or prenatal death.
Although metoclopramide is thought to be safe and is frequently used to treat nausea and vomiting, there has been a lack of data on risk specific malformations and fetal death. So Pasternak and colleagues examined data on 1,222,503 pregnancies in the Danish Medical Birth Register in which 45,002 women were exposed to metoclopramide. Congenital malformations during the first year of life were tracked using the Danish National Patient Register.
The researchers found a lower rate of spontaneous abortion among women exposed to metoclopramide vs. unexposed women, with the greatest differences observed at weeks 7 and 14 gestation. The cumulative incidence of spontaneous abortion among exposed women was about 3% versus 10% for the unexposed women from week 6 to week 14, and held fairly steady out to 22 weeks (log-rank P<0.001).
There was also no association between metoclopramide and an increased risk for stillbirth (HR, 0.90) — exposed women had a stillbirth rate of 3.5 per 1,000 versus 3.9 for unexposed women. The same was true for preterm birth, low birth weight and small for gestational age
“These safety data may help inform decision making when treatment with metoclopramide is considered in pregnancy,” the researchers concluded.