The first study of the anti-nausea drug metoclopramide in pregnant women has found that it is safe for both fetuses and mothers.
As many as 80% of expectant mothers suffer morning sickness in the first trimester of pregnancy. For the lucky ones, it can be controlled with saltines and frequent small meals. When such strategies do not work, physicians often prescribe drugs to control the nausea -- even though none are approved for such use in the United States. Compazine, Phenergan and Zofran are the most frequently prescribed, while metoclopramide -- sold both generically and under the brand names Reglan, Octamide and Maxolon -- is sometimes used for more severe cases. Metoclopramide is used more commonly in Europe and Israel, although there has previously been little information about its safety.
Two other drugs once used for morning sickness have been pulled from the market, leading many women and doctors to fear the use of any anti-nausea medication. Thalidomide, which was used in Europe and Canada in the 1960s but never approved in the U.S., caused missing or shortened limbs. Bendectin was withdrawn from the market in 1983 in the aftermath of highly publicized lawsuits alleging similar problems.
In the new study, a team led by Dr. Ilan Matok of Ben-Gurion University of the Negev in Beer-Sheva, Israel, studied a total of 81,703 births among mothers enrolled in Israel's largest HMO; 3,458 of the women used metoclopramide during their pregnancy.
Matok and his colleagues reported today in the New England Journal of Medicine that there were no significant increases in the incidence of birth defects or low birth weight in the group using the drug and a slight reduction in the incidence of stillbirth. The findings, they said, "provide reassurance regarding the safety of metoclopramide for the fetus when the drug is given to women to relieve nausea and vomiting during pregnancy."
Women are more cautious than doctors about using drugs during pregnancy, said Dr. Laura Riley of Massachusetts General Hospital, a spokeswoman for the Society for Maternal Fetal Medicine. "For some who are on the fence, [the findings] will allow them to take it," she told the Associated Press.
-- Thomas H. Maugh II