If you are pregnant and have taken ondansetron or Zofran® during pregnancy, I want to reassure you that it likely has not affected your baby. Even if the increased risk for cleft palate or heart defects turns out to be true, the risk to your baby is still very, very small.
How does Zofran affect the baby?
One recent meta-analysis of eight studies suggested that exposure to ondansetron in the first trimester could cause a very small increase in the risk of heart defects and orofacial malformations like cleft palate in babies.
Is it OK to take Zofran daily while pregnant?
Zofran is approved by the Food and Drug Administration (FDA) for use to fight off nausea related to chemotherapy. It is not currently approved by the FDA for morning sickness. Even so, most studies show that ondansetron is safe to use during the first trimester when most women experience morning sickness.
How often does Zofran cause birth defects?
Every pregnancy starts out with a 3-5% chance of having a birth defect. This is called the background risk. Most studies have found no increased chance for birth defects among thousands of people who used ondansetron in the first trimester of pregnancy.
Is Zofran safe during pregnancy second trimester?
A new study published in the New England Journal of Medicine concluded that the popular drug Zofran (used to treat nausea, vomiting and in some cases, hyperemesis gravidarum, in early pregnancy) poses no risk to the developing fetus.
Does Zofran cause cleft palate?
Data from the National Birth Defects Prevention Study shows Zofran causes a 237% risk of birth defect cleft palate. Up to 80% of women experience nausea and vomiting during pregnancy, nearly 16% of which take medication to help control these symptoms.
Can you take ondansetron in first trimester?
A new study from Brigham and Women’s Hospital finds that pregnant women taking the common anti-nausea medication ondansetron during the first trimester have no increased risk of cardiac malformations and only a slight increased risk of oral clefts.
Is there a lawsuit against Zofran?
GSK Agrees to Pay $3 Billion
Prior to the wave of personal injury lawsuits in 2015, the U.S. Department of Justice had brought a lawsuit against GSK, alleging the company “promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.”
How can I fight nausea during pregnancy?
Lifestyle and home remedies
- Choose foods carefully. Select foods that are high in protein, low in fat and easy to digest, and avoid greasy, spicy and fatty foods. …
- Snack often. …
- Drink plenty of fluids. …
- Pay attention to nausea triggers. …
- Breathe fresh air. …
- Take care with prenatal vitamins. …
- Rinse your mouth after vomiting.
What is safe to take for nausea while pregnant?
Vitamin B6 is a safe, over-the-counter treatment that may be tried first for nausea and vomiting of pregnancy. Doxylamine, a medication found in over-the-counter sleep aids, can be added if vitamin B6 alone does not relieve symptoms. A prescription drug that combines vitamin B6 and doxylamine is available.
What kind of birth defects does Zofran cause?
Zofran was found to double the risk of heart defects including atrial and ventricular septal (“hole in the heart”) defects and increased the overall risk of birth defects by 30% in one study. Another study found Zofran was linked with a 237% risk of cleft palate defects.
What category is Zofran in pregnancy?
US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Does ondansetron cause birth defects?
Taking Ondansetron During Pregnancy Does Not Appear to Increase Risk For Birth Defects.