By Gene Emery

BOSTON, June 10 (Reuters) - An anti-nausea drug that is widely used but little tested for safety in pregnant women does no obvious harm to the fetus, an Israeli study of thousands of users concluded on Wednesday.

Investigators found no increase in death or malformations among the babies of women given metoclopramide during the first trimester of the pregnancy.

It is widely used in Israel and some European countries. In the United States and Canada it is only given to counteract the most severe cases of morning sickness.

Up to 80 percent of pregnant women have at least one episode of nausea and vomiting during their first three months of pregnancy.

Using data from Israel's largest health maintenance organization, a team led by Ilan Matok of Ben-Gurion University of the Negev compared the outcomes of 3,458 women who took metoclopramide and 78,245 who did not.

"Until now, the assumption that the use of metoclopramide in pregnancy is not associated with congenital malformations has been based on studies with small samples, totaling 800 pregnancies," the researchers wrote in the New England Journal of Medicine.

They found that the drug produced no change in the risk of giving birth to a low-weight baby or to a child with a low Apgar score, a widely used measure of the health of a child immediately after birth.

The drug is made by a variety of companies, including Salix Pharmaceuticals <SLXP.O> and Baxter International Inc <BAX.N>.

More than 2 million Americans use metoclopramide for various stomach upsets but long-term use has been linked to tardive dyskinesia, which causes repetitive movements of the limbs, lip smacking, grimacing, tongue protrusion and rapid eye movements and blinking. (Editing by Maggie Fox)

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