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Morning Sickness Drug Gets Green Light in Study
Date:6/10/2009

Israeli researchers find short-term use during pregnancy should be safe,,,,

WEDNESDAY, June 10 (HealthDay News) -- A new study suggests that women who experience morning sickness early in pregnancy can safely take the medication metoclopramide to relieve their symptoms.

The study, which included nearly 3,500 pregnant women who took metoclopramide (Reglan), a drug developed to treat gastrointestinal (GI) problems, found no significant increases in the risk of birth defects, premature delivery, low birth weight or fetal death.

"It appears that metoclopramide is safe for short-term use to control GI problems in pregnant women when used as prescribed," said the study's senior author, Amalia Levy, a senior lecturer in epidemiology at Ben-Gurion University of the Negev in Israel. "Physicians are reassured about the safety of metoclopramide use in pregnancy in recommended doses."

Results of the study appear in the June 11 issue of the New England Journal of Medicine.

In Europe and in Israel, metoclopramide is often prescribed early in pregnancy to help quell that queasy feeling so common in the first trimester, according to the study's authors. Yet, like many drugs used in pregnancy, the effects of the drug on the growing fetus have not been well-studied. In the United States, the medication is usually reserved for women with severe morning sickness because it has not been approved by the Food and Drug Administration for use in pregnancy, the authors report.

And despite the study's findings, the use of metoclopramide is not without controversy. In February, the FDA added what's known as a "black box" warning to metoclopramide to alert people that long-term use of the medication (more than 12 weeks) or its use at high dosages has been associated with serious side effects. After long-term use, some people develop uncontrollable movements of the limb, face and tongue that don't go away even after they stop taking the drug.

But, the current study focused only on short-term use during pregnancy, and Levy said that use of metoclopramide in pregnancy is "usually for short terms and as needed."

For the study, the researchers reviewed 81,703 births between 1998 and 2007, all to mothers registered with a particular Israeli health system that has a computerized database of medical information. From that group, 3,458 women -- 4.2 percent -- were given metoclopramide during the first trimester of their pregnancies.

The study found no significantly increased health risks for babies of women exposed to the drug compared with the offspring of women who hadn't taken it. The risk of birth defects, for instance, was 5.3 percent in the metoclopramide group and 4.9 percent in the group not exposed to the drug. The researchers also found no significantly increased risk of low birth weight, premature delivery or fetal death.

"We worry about women with extensive nausea and vomiting during pregnancy," said Dr. Eva Pressman, director of maternal fetal medicine at the University of Rochester Medical Center in New York. "There's concern about dehydration and losing weight. The largeness of this study is clearly better than anything we've had to date on the safety of metoclopramide, and it shows that there are safe medications that you can use in pregnancy."

Pregnant women who are having morning sickness shouldn't just suffer through it, Pressman said. Instead, she said, talk to a doctor about ways to lessen the stomach upset.

More information

The March of Dimes has more on coping with nausea during pregnancy.



SOURCES: Amalia Levy, Ph.D., senior lecturer, Department of Epidemiology and Health Service Evaluation, Ben-Gurion University of the Negev, Israel; Eva Pressman, M.D., director, maternal fetal medicine, University of Rochester Medical Center, Rochester, N.Y.; June 11, 2009, New England Journal of Medicine


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