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Pregnancy Nausea Drug Not Linked to Birth Defects

Update Date: Oct 15, 2013 05:43 PM EDT

New research reveals that a drug used to treat nausea during pregnancy may not increase the risk of major congenital malformations, spontaneous abortion and stillbirth.

The nausea medication metoclopramide is often recommended if treatment with an antihistamine or vitamin B6 fails to work. However, research on the safety of metoclopramide in pregnancy is limited.

Lead researcher Bjorn Pasternak, M.D., Ph.D., of the Statens Serum Institut in Copenhagen wanted to investigate the associations between metoclopramide use in pregnancy and serious adverse outcomes.

The latest study involved data from 1,222,503 pregnancies in Denmark from 1997 to 2011. Researchers compared outcomes for women who used metoclopramide to those who did not.

The study showed that there were 28,486 live-born infants exposed to metoclopramide in the first trimester of pregnancy and 113,698 unexposed infants. Overall, 721 exposed and 3,024 unexposed infants were diagnosed with major malformation during the first year of life.

Further analysis of individual malformation categories revealed that there was 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 study also found no significantly 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," researchers concluded.

The findings are published in the journal JAMA.

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