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 is hard to know exactly just what kind of effects medications can have on an unborn child.
Many women have been taking the drug Zofran (ondansetron), which is approved by the FDA to treat nausea and vomiting in chemotherapy and surgery patients. However, this drug is not approved for use in pregnant women. Many women report that Zofran was the only way they were able to get through their nine months of pregnancy. However, a number of studies have implicated Zofran in causing birth defects in children. Zofran (ondansetron) has gained an increasingly widespread market share as an “off label” prescription for expectant mothers and there is no law or regulation stopping doctors from prescribing drugs off-label. There are innovative off-label uses of drugs that have helped patients, but many off-label prescriptions are written with no solid scientific proof that the drug will be safe or effective. Despite the fact that Zofran is not approved for use during pregnancy, many doctors will still prescribe the drug with full knowledge of its potential side effects on unborn children.
Because most women experience nausea and vomiting during the first trimester, they would be taking the drug at the same time the fetus is most vulnerable to developing malformations and deformities.
In August 2013, researchers from Denmark presented a study that covered the years 1997 to 2010 and nearly 900,000 pregnant women. The study detected a 2-fold increased risk of cardiac malformations with Zofran leading to an overall increased risk of major malformations of 30%. To rule out other indications for these results, the researchers also examined another drug (metoclopramide) taken for morning sickness, finding no increased risk for the birth defects.