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Pregnancy & Childbirth

Study Suggests Anti-Nausea Medication Safe for Mothers-to-Be

By: Madeline Ellis
Published: Friday, 12 June 2009
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Although there are many symptoms that accompany pregnancy, morning sickness tends to be one of the first, and often the most unpleasant. Usually beginning between the fourth and eighth week of pregnancy, morning sickness doesn’t necessarily occur in the morning; that feeling of nausea or vomiting can happen at any time of the day, even all day for some women. No one knows exactly why it occurs, but one thing is for certain; if you have morning sickness, you want it to go away. For the fortunate ones, it can be controlled by eating crackers or another light snack before getting out of bed, and eating frequent small meals during the day, but those strategies don’t always work and many women are reluctant to use medications for fear of harming the baby. But a new study may serve to alleviate that concern and help bolster approval of an anti-nausea medication specifically for morning sickness. 

The drug, metoclopramide, sold generically and under the brand names Reglan, Octamide, and Maxolon, is commonly dispensed in Europe and Israel to treat morning sickness, but is approved in the U.S. only for the treatment of heartburn and other intestinal disorders—not for use in pregnant women. In the U.S., mothers-to-be are given antihistamines instead, which help calm queasiness, with drowsiness as the only side effect for the mother and few lasting effects on the fetus. “Most times, we try to avoid using drugs, period,” said Dr. James Moran, chairman of obstetrics and gynecology at St. John’s Health Center in Santa Monica.

Previously, there had been little information about the safety of metoclopramide and only a handful of small studies to evaluate it as a treatment for morning sickness. For the new study, a team of researchers from Israel and Canada analyzed data on 81,703 births among women enrolled in a health maintenance organization in Israel. From that group, 3,458 of the women used metoclopramide during their pregnancies. The data showed no significant differences in birth defects or other problems in newborns of those who took the drug and those who did not. For instance, the risk of birth defects was 5.3 percent in the metoclopramide group and 4.9 percent in the group who were not exposed to the drug. The researchers also found no significantly increased risk of low birth weight, premature delivery or fetal death. “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 medications) just because of the stories they’ve heard and the perception that taking something in the first trimester can cause harm.”

“We worry about women with extensive nausea and vomiting during pregnancy,” said Dr. Eva Pressman, director of maternal fetal medicine at the University of Rochester Medical Center in New York. “There’s concern about dehydration and losing weight. The largeness of this study is clearly better than anything we’ve had to date on the safety of metoclopramide, and it shows that there are safe medications that you can use in pregnancy.”
 
The drug is believed to combat nausea by relieving the spasms that prompt queasiness. “What happens when people vomit or feel nauseous is that everything is stopped up,” explains Dr. Gideon Koren, director of the University of Toronto’s Motherisk Program for the study of antenatal drugs who worked on the study. “Metoclopramide helps move things forward and does not cause sedation like antihistamines.” Koren thinks that, given the weight of the results, “the FDA should look at it as a treatment for morning sickness,” but warns that more studies need to be done on the drug’s effectiveness.

It should be noted, however, that despite the study findings, metoclopramide is not without side effects, including insomnia, depression and anxiety. Also, in February, the FDA added what is known as a “black box” warning to the drug, alerting people that its long-term use (more than 12 weeks) or its use at high dosages has been associated with the development of uncontrollable movements of the limb, face and tongue in some people that don’t go away even after they stop taking the drug.

Two other drugs once used for morning sickness were pulled from the market. Thalidomide, used in Europe and Canada in the 1960s but never approved in the U.S., caused missing or shortened limbs. Bendectin was withdrawn from the market in 1983 after lawsuits alleged similar problems, though multiple studies and reviews by medical authorities never found such a link.

There are a considerable number of natural and safe remedies that can be tried before turning to prescribed medication. Melanie Grimes, HealthNews Natural Health Advisor, recently published an article on just that subject, which you can find here. There are also articles on Good Morning Mama, ginger, and other alternatives for nausea available on HealthNews.

While this may be an uncomfortable time of your pregnancy (and life), it will most likely be short-lived. If all else fails, know that metoclopramide could be an antidote to the problem. As with any prescription drug, discuss the pros and cons, as well as side effects, with your doctor prior to consenting to use.