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Zofran, also known as ondansetron, is an anti-nausea medication approved for cancer patients and people undergoing surgery who experience the side effects of nausea and vomiting. Although it’s not intended for pregnant women to take, Zofran has been prescribed for years as off-label use for morning sickness. In turn, numerous women who took Zofran during pregnancy are having infants with a string of birth defects, including severe abdominal malformations.

There are two primary types of abdominal birth defects that affects infants: gastroschisis and omphalocele.

Gastroschisis

Gastroschisis is birth defect marked by an infant’s intestines bulging out of his/her abdominal area, via a hole near the belly button. Gastroschisis begins to develop during early pregnancy after the abdominal muscles fail to grow and form properly. According to the Centers for Disease Control and Prevention (CDC), a little over 1,800 infants are born each year with gastroschisis.
baby crying in bed

Diagnosis of gastroschisis most often happens during pregnancy, but in some instances, the doctor will see the signs and symptoms shortly after the baby is born. During pregnancy, it’s detected via an ultrasound and/or blood work. If the blood work shows any abnormal results, physicians will typically order additional tests.

Treatment for gastroschisis will depend on the severity of the condition. For mild cases of gastroschisis, an infant usually undergoes “primary repair,” which is surgery that places the organs back into the correct position via a small hole in the abdomen. The abdomen is then closed.

For more serious cases, infants may undergo numerous surgeries before the problem is corrected. Known as “staged repair,” this form of treatment can take anywhere from 3 to 10 surgeries before its complete. During a staged repair, a plastic pouch (silo) is placed attached to abdominal area while covering the protruding organs. Once the protruding organs are pushed back into the correct place, the pouch is removed.

After surgery, the baby is normally given nutrition and fluids via an IV. Once the organs start functioning properly, the baby is switched over to formula or breast milk, and physicians will help parents formulate a successful home care plan.

Omphalocele

Omphalocele, also referred to as  exomphalos, is similar to gastroschisis in that an infant’s organs protrude from the abdominal area. However, according to the Merck Manual, organs protrude from from an area near the belly button during gastroschisis, whereas the organs protrude from the middle of the abdominal during omphalocele.

Omphalocele occurs around the sixth week of pregnancy, when the baby’s intestines begin to grow longer. Instead of forming in proper area, the intestines begin to push out of the belly area. This occurs because the abdomen fails to grow to its proper size, and the intestines have no room to form in the correct position. Around 750 babies are born with omphalocele each year.

Each case of omphalocele can differ. While one infant may have only a small portion of the intestines protruding out, another baby may have a large portion of his/her intestines bulging out of the abdomen. Omphalocele is generally diagnosed during pregnancy via prenatal screening tests. Yet, in some cases, physicians will diagnose the defect shortly after the baby is born.

As with gastroschisis, omphalocele is treated via surgery. For minor omphalocele, surgery typically starts soon after birth. The surgeon will make a small incision in the abdominal area and push the organs back into place. For severe cases of omphalocele, surgery is done in stages, similar to  gastroschisis. The opening is usually covered with protective materials during each surgery session. Once surgery is complete, the opening is sealed up.

Causes of Gastroschisis and Omphalocele

In some cases, abdominal birth defects are caused by maternal consumption of alcohol and/or drugs while pregnant. In addition, women who are obese during pregnancy run a higher risk of their babies developing abdominal defects.

Taking certain medications while pregnant also increases the risk of infants developing abdominal birth defects. Along with taking antidepressant medications, taking Zofran also heightens the risk of abdominal birth defects.

Currently, the United States FDA has only approved Zofran for cancer patients and those undergoing surgery. However, GlaxoSmithKline (GSK), the makers of Zofran, saw a huge market for the medication in pregnant women suffering from morning sickness. In turn, GSK began marketing Zofran as off-label use for morning sickness, and reportedly began offering kickbacks to doctor who prescribed the medication for off-label morning sickness.

Numerous studies performed on taking Zofran while pregnant indicate that there is high risk of babies developing a number of serious, life-threatening birth defects, including abdominal defects.

If You Took Zofran While Pregnant

If you took Zofran while pregnant and your baby was born with birth defects, you have the legal right to file for damages against the party that marketed the medication to pregnant women. Caring for an infant with birth defects is not only emotionally draining, but can get quite costly for medical expenses. You may be entitled to damages pain, suffering, medical expenses, lost wages, and more.

To learn more about your options, refer to our article, Zofran Lawsuit.