October 23, 2013
New Danish Study: Comforting News for Pregnant Women Treated for Uncontrolled Nausea

Copenhagen, Denmark—A large Danish study should provide some peace of mind to pregnant women prescribed drug therapy for hard-to-control nausea.

Metoclopramide did not increase the overall risk of major congenital malformations, spontaneous abortion, and stillbirth in an analysis involving more than 40,000 pregnant women using the nausea medication, according to the report published recently in the Journal of the American Medical Association.

The study, led by researchers from the Statens Serum Institut in Copenhagen, included 1,222,503 pregnancies in Denmark from 1997 to 2011, comparing outcomes for women who used metoclopramide to those who did not.

The study background notes that more than half of all pregnant women experience nausea and vomiting, usually early in their pregnancy, and that clinicians usually manage the condition conservatively. For the 10% to 15% of expectant mothers who eventually require drug treatment, metoclopramide often is recommended after antihistamines or vitamin B6 have been proven ineffective in controlling the symptoms.

The problem, however, is that data on the safety of metoclopramide has been limited, according to the study authors.

Researchers analyzed data from 28,486 infants born to mothers exposed to metoclopramide in the first trimester of pregnancy and 113,698 infants born to mothers who did not use the drug.

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, according to the researchers. Analysis of individual malformation categories showed no association between metoclopramide use in the first trimester and any of 20 malformations, including neural tube defects, cleft lip, cleft palate, and limb reduction.

In addition, the research indicated no increased risk of spontaneous abortion, stillbirth, preterm birth, low birth weight, and fetal-growth restriction associated with metoclopramide use in pregnancy.

“This nationwide study in Denmark assessed the safety of metoclopramide use in pregnancy, comparing metoclopramide exposed women with matched unexposed controls,” study authors note, adding, “As such, this study may help inform clinical decisions when treatment with metoclopramide is considered in pregnancy.”

U.S. Pharmacist Social Connect