Has Your Child Suffered Birth Defects or Injuries Because You Took Zofran?

Zofran (Ondansetron) has been linked to heart defects, cleft palate and cleft lip injuries.Photo of woman with pills

Zofran, used to treat nausea and vomiting in chemotherapy and surgery patients, has been linked to birth defects among children whose mothers’ took the drug during pregnancy. Aside from treating patients under these conditions, some physicians allegedly prescribed the medication, manufactured by GlaxoSmithKline (GSK), to treat morning sickness.

It should be noted that while doctors are allowed to prescribe medications for off-label reasons, it has been alleged in injury lawsuits that GSK promoted Zofran off-label for morning sickness. Remember, the practice of promoting and marketing a drug to doctors and health care professionals for unapproved indications is illegal.

Because of this, in 2012, GSK settled with the US Department of Justice (DOJ) over allegations that promoted a number of drugs off-label (allegedly including Zofran) to doctors. At the time, the DOJ called the settlement “the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.”

A December 2014 study published in the American Journal of Obstetrics and Gynecology indicated that pregnant women who took the drug during their first trimester of pregnancy have had children who have suffered serious injuries, as the drug can cross the placental barrier. Among the Zofran injuries reported:

  • Cleft lip: an opening or slit that goes through the lip into a victim’s nose
  • Cleft palate: an opening on the roof of a victim’s mouth where parts of the palate open
  • Heart defects including atrial septal defects and ventricular septal defects.

The study in the American Journal of Obstetrics and Gynecology found that approximately 110,000 pregnant women received monthly prescriptions for Zofran by the end of 2013, despite the fact that the U.S. Food and Drug Administration had not approved the drug for use during pregnancy.

Speaking to an Attorney about a Zofran Injury or Birth Defect

If you believe that you took Zofran during your first trimester of pregnancy and your child was born with a cleft palate, cleft lip, heart defect or another defect, we would like to talk to you. We could potentially review your medical records and see if the drug affected your child. Your son or daughter should not have had to suffer these injuries, which aside from potentially being superficial, may require forms of rehabilitation and surgery.

Keep in mind, our firm includes Dr. Ryan Krebs, M.D., J.D., whose skill set can help you and your child with this legal matter. Contact our experienced injury attorneys today for more information if you child was injured by Zofran. You may reach us by contacting the number above, or by filling out a request form.