Zofran® was approved by the U.S. Food and Drug Administration (FDA) in 1991 to treat nausea and vomiting caused by chemotherapy and radiation. The drug was also prescribed to treat morning sickness in pregnant women, but it was not approved by the FDA for this use.
The Center for Birth Defects Research and Prevention published a study in 2012 suggesting that women who used Zofran® during the first trimester of pregnancy had a twofold increase risk of having a child with birth defects.
Possible Zofran birth defects may include cleft lip, cleft palate, and congenital heart defects. Although Zofran® was not approved by the FDA for morning sickness, GlaxoSmithKline (GSK) promoted off-label use of the drug. GSK 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. Contact a Zofran lawyer to find out if you and your child are eligible for compensation.