A study into the safety of the anti-nausea drug metoclopramide, also known as the brand name Reglan, on pregnant women indicates that the drug is safe in mothers and their unborn children, according to a first-time study of the drug’s affects on expectant mothers. The drug is not indicated for pregnant women but the drug has an off-label indication for the treatment of morning sickness.
Metoclopramide is approved by the Food and Drug Administration (FDA) to treat severe heartburn, gastroesophageal reflux disease (GERD), and gastroparesis. Last year, the federal agency ordered a black box warning be placed on the drug following reports of a debilitating, involuntary movement disorder known as Tardive Dyskinesia most often associated with long term (greater than 12 weeks) use of the drug. The drug also carries warnings on its safety label of anxiety, depression and suicidal ideation.
Most physicians do not like to prescribe medication to expectant mothers because of concerns of how the drug will affect the unborn child. But as much as 80 percent of pregnant women suffer from morning sickness in the first trimester. For most, the nausea can be managed with small, frequent meals, but for some women, morning sickness can last well past the first trimester putting the mother and baby both at risk from dehydration and lack of nutrition. In such cases, some doctors have turned to off-label prescribing of various medications, including metoclopramide.
Metoclopramide is more commonly used off-label as a treatment for morning sickness in Europe and Israel, but the practice is beginning to carry over to the United States even though there have been no studies backing up the safety of the drug on pregnant women and their unborn children.
But, a new Israeli study, reported in the New England Journal of Medicine, studied a total of 81,703 births among mothers enrolled in Israel’s largest HMO, 3,458 of whom used metoclopramide during their pregnancy. The study showed that there were no significant increases in the incidence of birth defects or low birth weight in the group using metoclopramide, and there was even a slightly lower incidence of stillbirth.
Researchers say the findings provide reassurance regarding the safety of metoclopramide for the fetus when the drug is given to women to relieve nausea and vomiting during pregnancy. However, women who take the drug – whether pregnant or not – should use care and heed the label’s safety warnings as the drug can cause serious, even life-threatening, problems.