An anti-nausea drug already widely used around the world but little tested for safety in pregnant women appears to do no harm to the fetus, a large Israeli study has found.
The study published in the New England Journal of Medicine found no increase in death or malformations in babies among women given metoclopramide during the first trimester of the pregnancy, the period when about 80 per cent of pregnant women experience nausea.
Metoclopramide is widely used in Israel and some European countries, and sold as Reglan and in generic form.
In Canada, the drug of choice for treatment of morning sickness remains Diclectin, a combination of doxylamine and vitamin B6. Metoclopramide is given in Canada and the United States in only the most severe cases of morning sickness, when vomiting can cause dehydration and be harmful to the health of both baby and mother.
In the U.S., no drugs at all are approved for morning sickness. Nevertheless, U.S. doctors sometimes use medicines approved for other types of nausea that are thought to be safe in pregnancy, such as Compazine, Phenergan and Zofran.
Until now, the assumption that metoclopramide doesn't cause birth defects has been based on studies with small samples, totalling 800 pregnancies.
This study used data from Israel's largest health maintenance organization and compared the outcomes of 3,458 women who took metoclopramide and 78,245 who did not.
The team led by Ilan Matok of Ben-Gurion University of the Negev found that the drug produced no change in the risk of giving birth to a baby with a major congenital malformation. Nor was there an increased risk for preterm delivery, perinatal death, or giving birth to a baby with a low birth weight.
The study did not evaluate the drug's effectiveness.
Metoclopramide works by speeding emptying of the stomach and reducing heartburn, can have side effects, including sedation, insomnia, depression and anxiety.
Long-term use has been linked to a condition called tardive dyskinesia, which is marked by repetitive movements of the limbs, lip smacking, grimacing and rapid eye movements.
