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Taking Zofran while pregnant has been linked to numerous birth defects, including hypospadias, a serious defect affecting male babies. If you took Zofran while pregnant and had a baby born with hypospadias, it’s important to note that you may be eligible for compensation for pain, suffering, medical expenses, and more.

What is Hypospadias?

According to the Centers for Disease Control and Prevention (CDC), hypospadias is a birth defect that affects male infants, in which the opening of the tube that carries urine (urethra) is not formed properly. Hypospadia generally occurs anywhere between the 8th-14th week of pregnancy.

Hypospadias occurs when the urethra forms in the shaft of the penis (midshaft), towards the top of the penis (subcoronal), or in the scrotum and lower penis area (penoscrotal). If not treated, boys will have ongoing problems with urination, including spraying, and sexual dysfunctions later in life.

Causes and Risk Factors of Hypospadias

Although it’s still uncertain exactly what causes every case of hypospadias, there are several risk factors that may contribute to increasing the risk, including:

  • Maternal age of 35 years and older
  • Maternal use of fertility treatments
  • Hormonal medication

Hypospadias isn’t usually diagnosed until after the baby is born, so it’s important to take healthy prenatal measures to decrease risks. If you plan to become pregnant, be certain to speak with your physicians about other healthy steps you can take.

The Link Between Hypospadias and Zofran

Although the numbers are still relatively low, there has been a confirmed link between some women who took Zofran while pregnant and hypospadia. In 2004, BJOG, an international journal of obstetrics and gynaecology, linked hypospadias to numerous cases in which pregnant women took Zofran.

Although the study wasn’t large enough to successfully confirm the chances of infants developing hypospadias associated with Zofran, it did indicate that 3.6% of the women researched in the study gave birth to infants with birth defects, some of which included baby boys with hypospadia.

How is Hypospadias Treated?

In most instance, surgery is required to successfully treat hypospadias. Surgery is typically postponed until the baby is around three months of age, but can also take place up to 18 months of age. CDC indicates that that sometimes surgery is performed in stages, depending on how severe the condition is.

In addition, if hypospadias is diagnosed, the physician will more than likely advise against circumcision as part of the foreskin may be needed when correcting the condition.

Expenses Associated with Hypospadias

The expenses associated with hypospadia can get costly, even with insurance. For instance, surgery can range anywhere from $10,000 to $20,000 (sometimes slightly more or less), and insurance may only cover a portion of the total costs.

If you think your baby’s hypospadia was caused by Zofran use, it’s highly recommended to seek legal consultation to see if you qualify for compensation. Since GlaxoKlineSmith, the makers of Zofran, marketed that medication as off-label use for morning sickness, they may be liable for any damages incurred.

Zofran is currently only prescribed for nausea and vomiting in cancer patients, yet GlaxoKlineSmith has continuously marketed it for use by pregnant women, even though the company knows it’s not approved for use for morning sickness.