Zofran and Birth Defects

ZOFRAN to treat morning sickness

Zofran is used to prevent nausea and vomiting that may be caused by chemotherapy or radiation in treating cancer. It also has been used off-label by pregnant women to treat morning sickness and may be linked to to birth defects in babies including:

  • Cleft palate – malformation in early pregnancy where there is an split or opening in the roof of the mouth
  • Cleft lip – malformation early in pregancy where the two side of the upper lip has a gap in the skin
  • Atrial Septal Defect (ASD) – a hole in between the two upper chambers of the heart
  • Ventricular Septal Defect (VSD) – a hole in between the two lower chambers of the heart
  • Other congenital heart defects.


  • Hypersensitivity to other selective 5-HT3 receptor antagonists
  • Co administration of Apomorphine – Causes profound hypotension and loss of consciousness
  • Serotonin syndrome – Adverse drug interaction
  • Avoid usage in patient with congenital QT syndrome


Lawsuits alleging birth defects from Zofran have been consolidated into a multidistrict litigation (MDL) before Judge Dennis F. Saylor, IV, in the District of Massachusetts.  As of December 1, 2015, over 220 lawsuits have been transferred to the MDL.

Court Records:

The zofran lawsuits filed include these allegations:

  • That Glaxo had a legal obligation to ensure that Zofran was safe before releasing it, and failed to determine its safety risks before promoting it.
  • That the company failed to adequately warn the public and medical communities about the risk of Zofran side effects.
  • That Glaxo marketed Zofran as a safe treatment for morning sickness and hyperemiesis gravidarum even though it had not been approved by the FDA for this use.
  • That Glaxo misrepresented animal studies indicating that Zofran was safe, when in reality the studies showed abnormal bone growth and signs of toxicity.
  • That Glaxo failed to properly analyze all data and safety information regarding Zofran use in pregnant women.
  • That the company manufactured a defective drug.
  • That the company falsely claimed it was safe for pregnant woman.

The Ruth Law Team is currently investigating birth injury claims induced by Zofran.  If you or a loved one has taken Zofran for morning sickness and had a baby with a birth detect, contact the experience lawyers now at 1-888-783-8378 for a free consultation.