Zofran Birth Defect Lawsuit

This drug has been marketed as, ondansetron, Zofran, Zofran ODT, and Zuplenz.

Zofran is an anti-nausea drug that was introduced by GlaxoSmithKline in 1991. While the drug is not FDA approved for use in pregnant women, approximately one million women are prescribed Zofran and its generics each year to deal with morning sickness. This type of unapproved use is called “off-label“Off-label use is legal, but it can lead to dangerous results.

Zofran use during pregnancy may lead to serious birth defects.

Since 1991, the FDA has received hundreds of reports of birth defects in children born to women took Zofran to help with morning sickness. Data about whether ondansetron causes birth defects is still inconclusive, butseveral studies have shown a correlation between Zofran use and an increased risk of birth defects.

Possible Birth Defects

Birth Defects that have been reported include:

  • Congenital Heart Defects
  • Kidney Malformation
  • Cleft Palate
  • Gastrointestinal Defects
  • Limb Malformation
  • Respiratory Defects
  • Many Other Birth Defects


Recent Updates

  • March 2016: Last month Zofran manufacturer, GlaxoSmithKline (GSK), requested that the court throw out all Zofran lawsuitswithout allowing families to prove their case. Judge F. Dennis Saylor IV refused GSK’s request. In doing so, he said he was “loath to dismiss” the claims without giving the families a chance to develop the facts of their cases. Because of Judge Saylor’s decision, families will be able to continue in the discovery process which will allow both sides to investigate exactly what type of connection may exist between Zofran use and birth defects.


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