Zofran (ondansetron) is a medication used to treat severe nausea and vomiting. The medication received approval to treat the most severe forms of nausea and vomiting associated with cancer treatment and following surgery.

GlaxoSmithKline, the maker of Zofran, realized that the drug was also helpful for pregnant women dealing with the nausea and vomiting associated with morning sickness.

Women began taking the medication as prescribed by their physicians, however, Zofran was never FDA approved for use by pregnant women.

Morning sickness is very common, with about 80% of women reporting that they experienced some nausea or vomiting during pregnancy. Some women have a very severe form of morning sickness called hyperemesis gravidarum, where the nausea and vomiting is so severe it causes malnutrition and can pose a danger to both the mother and her unborn child.

Women who had taken Zofran as a morning sickness treatment began to report that their children were born with birth defects. For many of these children, there was no family history or genetic reason to explain the birth defects these children developed.

Birth Defects Reported by Zofran Users

A variety of different birth defects have been reported as a result of Zofran use. The most common defects include heart defects and cleft lip or palate.

A common occurrence in heart defects allegedly linked to Zofran use include septal defects. This is more commonly known as a hole in the heart. This condition causes in adequate circulation of oxygen-rich blood.

Cleft lip and cleft palate are mouth deformities that affect the that not only cause physical deformity but can also lead to a number of functional problems as well. Feeding problems, speech problems, repeated ear infections and dental problems are all common in children with cleft lip and cleft palate.

Other physical deformities have also been report

Zofran Lawsuit Information

Currently, hundreds of families have filed lawsuits against GlaxoSmithKline. Many of these lawsuits are currently pending in the multidistrict litigation located in the U.S. District Court for the District of Massachusetts.

These lawsuits claim that the manufacturer paid physicians to promote Zofran and “false representations about the safety and efficacy” of the drug were made. Plaintiffs also claim that had they known about the risk of birth defects in their children, they never would have taken the drug while pregnant.

Filing a Zofran Lawsuit

If you have taken Zofran during pregnancy and have had a baby born with birth defects, you may be eligible to file a lawsuit against GlaxoSmithKline.  Our experienced attorneys can provide a no-cost consultation to you to discuss your situation and can inform you of your legal options.