Morning Sickness Drug Gets Green Light in Study

June 11 -- 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."