By Margarita Nahapetyan
An anti-nausea drug metoclopramide, that has been widely used by pregnant women who suffer morning sickness, but little tested for safety, was found to pose no significant risks for both the fetus and the mother, claims a large cohort study by Israeli scientists.
The study, titled "The Safety of Metoclopramide Use in the First Trimester of Pregnancy," found that the drug which was approved in the United States for nausea, vomiting and heartburn, posed no significant increases in the risk of birth anomalies, pre-term delivery, low birth weight or fetal mortality. "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 co-author, Amalia Levy, a senior lecturer in epidemiology at Ben-Gurion University of the Negev in Israel. Doctors are reassured about the safety of metoclopramide use during pregnancy in recommended doses, she said.
Morning sickness can be more than unpleasant. As many as 80 per cent of pregnant women suffer morning sickness in the first three to four months of pregnancy. As a result of it, some women lose a lot of weight or even are being hospitalized. For the lucky ones, the condition can be controlled with saltines and frequent small meals. However, some doctors and future mothers-to-be are reluctant to use medicine because of scares that it might harm the fetus.
Compazine, Phenergan and Zofran are the most frequently prescribed anti-nausea drugs in the United States, while metoclopramide, which is being sold both generically and under the brand names Reglan, Octamide and Maxolon -- is sometimes used for more severe cases. The drug is used more commonly in Europe and Israel, in spite of the fact that there has previously been little information about its safety.
For the study purposes, a team of researchers led by Dr. Ilan Matok of Ben-Gurion University of the Negev in Beer-Sheva, analyzed nearly 82,000 births between 1998 and 2007, all to women who have been registered with a particular Israeli health system that has a computerized database of medical data. From that group of women, 3,458 expectan mothers -- 4.2 per cent -- were taking metoclopramide during the first trimester of their pregnancies.
The results revealed that exposure to the drug was not associated with significantly increased risks of major birth defects. The rate of major congenital malformations identified in the group of women exposed to metoclopramide during the first trimester was 5.3 per cent (182 out of 3,458 babies), as compared with a rate of 4.9 per cent (3,834 out of 78,245 babies). The results were unchanged when therapeutic abortions of exposed fetuses were included in the analysis. In addition to all this, the investigators also found no significantly increased risk of low birth weight, premature delivery or fetal death.
More than 2 million people in the Unites States use metoclopramide for various stomach upsets but long-term use of the drug has been associated with condition, such as tardive dyskinesia, which leads to repetitive movements of the limbs, lip smacking, grimacing, tongue protrusion and rapid eye movements and blinking.
The findings are published in the June 11 issue of the prestigious New England Journal of Medicine.