For the first time, a large study shows that pregnant women who suffer morning sickness are not risking harm to their babies if they take the anti-nausea drug metoclopramide.
The result might lead more doctors to prescribe the drug and women to feel less guilty about using it during their baby's crucial first few months of development, experts said.
'I think that women will be comforted by this.' — Dr. Keith Eddleman
Currently, no drugs are approved in the U.S. for morning sickness, which plagues most women in the first three months of pregnancy — lasting all day for some. Doctors sometimes use medicines approved for other types of nausea that are thought to be safe in pregnancy when simple strategies such as eating crackers and frequent, small meals don't help.
The study looked back at nearly 82,000 births in Israel, where metoclopramide is commonly used. It found no difference in birth defects or other problems in newborns whether or not mothers took the drug, sold under the brand name Reglan and in generic form.
"I think that women will be comforted by this," said Dr. Keith Eddleman, director of obstetrics at Mount Sinai Medical Center in New York. "Most women are reluctant [to take anti-nausea medicine] just because of the stories they've heard and the perception that taking something in the first trimester can cause harm."
Results of the study, which did not look at the drug's effectiveness, were reported in Thursday's New England Journal of Medicine.
Morning sickness can be more than unpleasant. It can cause some women to lose weight or send them to the hospital. But some doctors and women are reluctant to use medicine because of scares decades ago over several drugs used for morning sickness.
Limb deformity fears
Thalidomide, used in Europe and Canada in the 1960s, caused missing or shortened limbs in newborns. The maker of another drug, Bendectin, sold in Canada as Diclectin, pulled it from the U.S. market in 1983 after widely publicized lawsuits alleged it caused limb deformities.
Multiple studies and reviews by medical authorities never found such a link, and Bendectin is being reintroduced to the U.S. market.
Despite the millions of births each year — about 4 million in the U.S. alone — there still have been no large, well-designed studies on the safety of medicines in treating morning sickness, mainly because of fears of harming the fetus and triggering lawsuits.
The Israeli study, led by researchers at Ben-Gurion University, included pregnant women enrolled in Israel's largest HMO from 1998 through 2007.
It compared the health of newborns of 3,458 women who took metoclopramide, for as little as a week to more than three weeks, with 78,245 newborns of women who had not used it. Rates of problems were low and similar in both groups.
The safety finding might reassure women, who often are more cautious than their doctors about using a drug during pregnancy, said Dr. Laura Riley, a Massachusetts General Hospital obstetrician and spokeswoman for the Society for Maternal Fetal Medicine.
"For some who are on the fence, it'll allow them to take it," she said.
In the U.S., other drugs — Compazine, Phenergan and Zofran — are generally used more often than Reglan, which is made by Schwarz Pharma Inc. of Smyrna, Ga.
The new study should lead obstetricians to prescribe it more often, some experts said.
Until now, doctors have only assumed it is safe, based on a couple small studies and the lack of reports of serious problems, said Dr. Jeffrey Chapa, head of maternal fetal medicine at the Cleveland Clinic.
Metoclopramide, which works by speeding emptying of the stomach and reducing heartburn, can have side-effects, including sedation, insomnia, depression and anxiety.
Metoclopramide is approved for use in Canada, according to Health Canada's online database.