Metoclopramide treatment for nausea during pregnancy is not associated with increased risk of major malformations or stillbirth

by Bruce Sylvester – taken from JAMA – Journal of the American Medical Association – A retrospective analysis of data on Danish women exposed to the nausea medication metoclopramide in pregnancy shows that the drug is not associated with a significantly increased risk of major congenital malformations, spontaneous abortion, and stillbirth. The findings appear in the October 16 issue of the Journal of the American Medical Association (JAMA).

As background, the authors noted that over half of pregnant women experience nausea and vomiting, and 10 percent to 15 percent of those with nausea and vomiting will eventually receive drug treatment. If treatment with an antihistamine or vitamin B6 fails, metoclopramide is often recommended. However, even though metoclopramide is commonly used, data on the safety of its use in pregnancy have been limited.

Bjorn Pasternak, M.D., Ph.D., researcher at 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 data on pregnancies in Denmark from 1997-2011. The investigators compared outcomes for women who had used metoclopramide to those who had not.

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

Following an analysis of individual malformation categories, the investigators reported 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 investigators also found no increased risk of spontaneous abortion, stillbirth, preterm birth, low birth weight, and fetal growth restriction associated with metoclopramide use during pregnancy.

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