Published February 28, 2013
Many expectant mothers are wary of taking drugs during the early weeks of pregnancy, as this time period can be crucial for the development of their baby. However, sometimes it’s hard to know for sure just what kind of effects medications can have on an unborn child.
Fortunately, many mothers can now rest easy when it comes to one very common medication. A recent study from researchers at the Statens Serum Institut in Copenhagen found that the drug Zofran, which is used to treat nausea and vomiting, is safe to use during early pregnancy and poses no increased risk to the developing fetus.
Published in the New England Journal of Medicine, this Danish study included the analysis of 608,385 pregnancies in Denmark. After extensive statistical analysis comparing pregnant women who had been exposed to Zofran and those who had not been exposed, the conclusions were quite clear: that there were no increased incidences of miscarriages, still births or birth defects in the newborn. There were also no increased incidences of preterm labor or low birth weight babies for women who had taken the drug.
One of the most common conditions in a healthy pregnancy is morning sickness. While usually nothing more than a frustrating pregnancy symptom, morning sickness can sometimes be very debilitating, especially if it turns into hyperemesis gravidarum – which can lead to severe vomiting and dehydration.
Hyperemesis gravidarum was recently in the news in December when it was revealed that the Duchess of Cambridge, Kate Middleton, had been hospitalized for the condition. Luckily she was released after just a few days of treatment, and by all reported accounts, her pregnancy seems to be progressing just fine.
Morning sickness and hyperemesis sometimes appears in the first few weeks of pregnancy, and often requires the use of medications. One of the most commonly used drugs for this condition today is ondansetron, known by its brand name as Zofran.
Zofran was developed in 1984 for the treatment of nausea and vomiting after chemotherapy. The drug is metabolized in the liver and has a half-life of about five to seven hours. Some of the common side effects include constipation and headaches.
While originally intended for another condition entirely, its use in pregnancy has skyrocketed over the last decade, and most obstetricians prescribe it off label. In other words, Zofran has not been officially approved by the FDA for use during pregnancy.
That is why this very comprehensive study is so important. First, the safety of Zofran in pregnancy has never been clearly assured. And second, this drug is utilized so early in pregnancy that many obstetricians and patients wondered if it led to adverse effects in the developing fetus. One case-control study had found that the use of ondansetron during pregnancy was linked with an increased risk of cleft palate in the newborn; but this new research seems to dispute that claim.
So this study should give some peace of mind to pregnant women who are currently taking this drug, as well as those women that have experienced morning sickness in the past and are thinking about getting pregnant in the future.