Zofran Birth Defect Warning
Zofran has been linked to serious birth defects.
FDA Warns Against Zofran Use in Pregnancy
The FDA has issued an updated warning against Ondansetran, better known by its brand name, Zofran, use in pregnancy discussed in OBGYN News. Zofran is a 5-HT3 receptor antagonist approved by the FDA for preventing nausea and vomiting related to cancer chemotherapy and surgery. It has been used off-label to treat nausea and vomiting in pregnancy. Based on recent studies regarding the association between Zofran use in early pregnancy and congenital cardiac malformations and oral clefts (cleft lip and palate), the FDA has cautioned against its use in pregnancy. There are also potential maternal risks associated with taking Zofran especially in pregnant women with electrolyte imbalance due to severe nausea and vomiting. These risks include the Serotonin Syndrome which is a triad of cognitive or behavioral changes including confusion, agitation, autonomic instability, and neuromuscular changes. Therefore Zofran should not be taken during pregnancy.
While the medication is only approved for treatment of nausea and vomiting symptoms among chemotherapy patients and following surgery, it has been widely used “off-label” as a morning sickness drug.
Although Zofran was not approved by the FDA for morning sickness, GlaxoSmithKline promoted off-label use of the drug. GlaxoSmithKline agreed to pay $3 billion in 2012 to settle numerous allegations including illegally marketing Zofran for non-approved use. Mothers who took Zofran during pregnancy and had a child with cleft lip, cleft palate, or heart defects may be entitled to compensation.
If you took Zofran while pregnant and your child has born with serious birth defects, including -cleft lip, cleft palate and heart or kidney defect.
You and your child may be entitled to financial compensation.