At least one mother has filed a lawsuit against Zofran (ondansetron) maker GlaxoSmithKline (GSK), alleging that the drug caused her son’s birth defect. In hypospadias, the opening of the urethra is not at the tip of the penis, but somewhere along the shaft or where the penis and scrotum meet. Hypospadias in baby boys has been associated with Zofran use by the mother. Zofran is not and never has been approved for use by pregnant women, but doctors prescribe it to treat morning sickness.
2004 Study Links Zofran to Hypospadias
Zofran was approved by the U.S. Food and Drug Administration (FDA) in 1991. It was approved as an anti-nausea medication, not to treat morning sickness, but for cancer patients undergoing chemo and other treatments. In spite of the fact that the drug was not approved for use during pregnancy and that GSK had been notified of birth defects resulting from Zofran use in early pregnancy, the drug maker aggressively pushed the drug as a treatment for morning sickness as soon as it hit the market.
Then, in 2004, the British Journal of Obstetrics and Gynaecology (BJOG) published a study that found a possible link between Zofran use and hypospadias. Of the 176 pregnancies studied there were three cases of hypospadias. The defect normally only occurs in about one in 300 boys, so there was a much higher rate in babies of women who took Zofran.
However, since the sample size was so small it could not be said for certain that Zofran creates an increased risk for hypospadias. The researchers urged further study of the drug and said that safety data is lacking.
In hypospadias the opening of the urethra is not where it is supposed to be. The urethra is the tube that carries urine from the bladder to the outside of the body, with the opening normally located at the tip of the penis.
Although it is not life-threatening in itself, hypospadias can cause serious problems for the boys who suffer with it. The defect is almost always treated with surgery that is performed during infancy, typically when the child is three to 18 months old. Multiple surgeries are necessary in severe cases.
Boys with hypospadias can endure many problems including having to sit down to urinate due to spraying, having a curved penis, pain, and later in life the defect can cause problems with sexual intercourse.
In hypospadias the placement of the opening of the urethra can fall in one of three categories:
- Subcoronal – near the head of the penis
- Midshaft – along the shaft of the penis
- Penoscrotal – where the penis and scrotum meet