Zofran Linked to Birth Defects

Mothers who have taken Zofran during their pregnancy may have unknowingly exposed their babies to a higher risk for severe birth defects including cleft palates and heart defects. If you took Zofran between 1998 and 2007 and had a newborn with a birth defect, it may be important to contact an attorney who can help you protect your potential legal claim – call our firm at 1.800.887.8029.


Zofran is an anti-nausea medication predominantly used for patients undergoing cancer chemotherapy, radiation therapy, and surgery. It is alleged that GlaxoSmithKline (GSK), the maker of Zofran, failed to warn patients of the risks and promoted Zofran off-label to treat moderate to severe morning sickness despite never being approved for use by pregnant women. In 2012, GSK agreed to pay $3 billion to resolve charges with the U.S. Department of Justice regarding the improper promotion of various drugs, including Zofran.

Zofran Risks and Birth Defects

Some birth defects and health risks that Zofran may cause in newborns are:

  • Heart defects, including heart murmurs or holes in the heart
  • Musculoskeletal abnormalities and deformations
  • Kidney malformations
  • Mouth deformities, including cleft palates
  • Death

What is Cleft Lip and Cleft Palate?

Cleft lip and cleft palate are birth defects that occur when parts of the developing lip or palate of the developing baby do not completely fuse together early in the first trimester of pregnancy. The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking, and to ear infections. Surgery often is performed during the first year of life to close the lip and palate and most children do well after treatment.

How We Can Help

If you have taken Zofran while pregnant and have a child with a birth defect, you may want to consider your potential legal claim. For more information, or to speak with someone about your potential case, please call us at 1.800.887.8029 or fill out our free case review form. Zimmerman Reed is experienced in handling defective drug cases and we welcome your questions.