Zofran, an anti-nausea drug that is prescribed by doctors for the “off-label” treatment of morning sickness. Zofran has been linked to an increased risk and a doubled risk of heart defects and cleft palate, according to several recent studies.
What is Zofran?
Zofran is approved to treat nausea and vomiting in chemotherapy and surgery patients. The FDA has not approved Zofran for pregnant women, but some doctors prescribe it “off-label” to treat severe morning sickness.
Zofran was developed by GlaxoSmithKline (GSK) and approved in the United States in 1991. The first generic versions were approved in 2006.
Morning Sickness
Nausea and vomiting are estimated to affect 70-85% of pregnant women during weeks 6-12 of pregnancy, but extreme morning sickness, only affects about 1% of all pregnancies
Zofran is not approved for use during pregnancy. The FDA classifies Zofran as a “Pregnancy Category B” medication, which means animal studies have not found evidence of a risk, but no one knows if it is safe. Pregnant women with questions about Zofran should talk to their doctors.
Zofran Pregnancy Studies
There have been several recent studies that have linked increased birth defects to patients that took Zofran in the first trimester. If you or a loved one has taken Zofran, call our attorneys for a free case evaluation.
Pregnancy Risks Linked to Zofran
- Atrial Septal Defect
- Heart Defects
- Heart Murmur
- Cleft Palate
- Kidney Defects
Call (214) 261-5679 to talk with an attorney today.