Stomach Drug Discovered Safe For Relieving Nausea During Pregnancy
The women who took the medicine, metoclopramide, didnt have a higher rate of premature birth, according to research published online today in the New England Journal of Medicine. The study also found their babies didnt have a higher risk of malformations or low birth weight compared with the infants of women not taking the drug.
As much as 80 percent of women experience nausea and vomiting in their first trimester of pregnancy and no medicine approved by the U.S. Food and Drug Administration is available currently to treat the condition, study author Gideon Koren said. Another large study is needed in pregnant women to confirm if metoclopramide is effective in relieving morning sickness, he said.
“People were very hesitant to use it in pregnancy because they didnt know it was safe,” said Koren, director of the Motherisk Program at the Hospital for Sick Children in Toronto and a professor at the University of Toronto in a June 9 telephone interview. “You cannot answer those questions with small numbers. This is the first ground-breaking study of almost 5,000 women. It answers the questions totally.”
Metoclopramide tablets, syrups and injections are sold by several generic drugmakers and under the brand name Reglan by Marietta, Georgia-based Alaven Pharmaceutical and by Baxter International Inc., based in Deerfield, Illinois. The medicine has been approved by the FDA to treat heartburn and digestive problems.
Israeli HMO
The researchers analyzed the records of women who were members of Clalit Health Services, the largest health maintenance organization in Israel, according to the paper. From January 1998 through March 31, 2007, there were more than 81,000 babies born. Of those, 3,458 babies, or 4.2 percent, were exposed to metoclopramide during the first three months of their mothers pregnancy.
They found that major birth defects occurred in 5.3 percent, or 182 of the 3,458 infants who had been exposed to metoclopramide, compared with 4.9 percent, or 3,834 of the 78,245 whose mothers didnt take the treatment.
Among the babies whose mothers were in the metoclopramide group, 85 percent or 295 had low birth weight and 6.3 percent or 219 were delivered early. That compared with 8.3 percent or 6,497 having low birth weight and 5.9 percent or 4,593 born prematurely in the group whose mothers didnt receive the treatment. None of the differences were statistically significant, the study said.
Wide Use
“Metoclopramide is the drug of choice in Europe and Israel for morning sickness-like symptoms of nausea and vomiting. In the U.S. however, it is only used in the most severe cases, as it is an off-label use,” said study author Rafael Gorodischer, a professor at Ben-Gurion University of the Negev in Israel, in a statement. “The findings provide significant reassurance for the safety of the fetus when the drug is given to women to relieve nausea and vomiting during pregnancy.”
Metoclopramide works to relieve nausea and vomiting by increasing movement in the stomach muscles, accelerating the stomachs emptying into the intestines. It also works in the area of the brain that is responsible for vomiting, Koren said.