Off-label Morning Sickness Drug Zofran May Cause Hypospadias Birth Defect

Product Liability
Defective Medical Devices
Birth Defects

Zofran (ondansetron), is an anti-nausea medication that was approved for use in cancer patients undergoing chemotherapy and other treatments, in 1991. It was not approved for use in pregnant women, but in the absence of FDA-approved morning sickness treatments, it became the go-to drug for nausea and vomiting of pregnancy (NVP). Its popularity as a treatment for morning sickness can be attributed to aggressive off-label market by maker GlaxoSmithKline (GSK).


Hypospadias is a birth defect in boys in which the opening of the urethra is not at the tip of the penis, where it should be. Instead is it in one of the following areas:

  • Subcoronal – near the head of the penis
  • Midshaft – along the shaft of the penis
  • Penoscrotal – where the penis and scrotum meet

The defect can cause many problems including a curved penis, having to sit down while urinating due to spray, and problems with sexual intercourse later in life. Babies born with Hypospadias require surgery to correct the defect, typically sometime between the ages of three and 18 months. Multiple surgeries may be required.

Zofran and Hypospadias

A study published in 2004 found a potential link between Zofran use and hypospadias, but the sample size was too small to be conclusive. The study authors called for more research on the risk.

Zofran carries no warning of the risk of hypospadias. At least one mother has filed a lawsuit against GSK after discovering the potential link between her Zofran use and her son’s hypospadias. Her son has had surgery, but it did not correct the problem and he is still in pain at three years old.

If your child was born with hypospadias or another birth defect after you used Zofran in pregnancy, an experienced defective drug attorney may be able to help you recover substantial compensation that can pay for your child’s needs.

Add new comment