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Taking Zofran (also known as ondansetron) while pregnant has been linked to numerous birth defects, including craniosynostosis. The medication, only intended for cancer patients experiencing nausea and vomiting after chemotherapy and other forms of treatment for cancer, has been prescribed to pregnant as a off-label use for morning sickness.

What is Craniosynostosis

Craniosynostosis is a birth defect that occurs when the joints in an infant’s skull close prematurely, before the brain is formed. In turn, the baby’s head cannot form properly, resulting in an unnatural head shape.
Craniosynostosis

If a baby has craniosynostosis, it may affect his/her skull joints, which may prevent the brain from growing properly. It’s a serious birth defect that generally requires prompt treatment.

Symptoms of Craniosynostosis

The most common signs of craniosynostosis include:

  • Extremely slow or now head growth as the baby gets older
  • Unnatural, misshapen head
  • Ridges along the along the suture area
  • Intracranial pressure
  • No “soft spot” on top of the baby’s head

Different Types of Craniosynostosis

There are numerous types of craniosynostosis birth defects. Physicians usually determine the different types according to the sutures affected. The most common types of craniosynostosis birth defects include:

Bicoronal Aynostosis

When the coronal sutures fuse together too soon, bicoronal aynostosis occurs. It affects the infant’s forehead by flattening it and/or elevating it.

Sagittal Synostosis

Sagittal Synostosis occurs when the sutures on top of the infant’s head fuse together prematurely. In turn, the baby’s head grows too long and narrow.

Coronal Synostosis

Coronal Synostosis occurs when the sutures on the infant’s head that go across to each ear develop prematurely. Babies with coronal synostosis may have a flattened look to their forehead and elevated eyebrows.

Craniosynostosis Causes

In some instances, craniosynostosis is caused by genetic anomalies, metabolic disorders, or hematologic disorder. In other cases, the cause is unknown. Taking medications while pregnant, such as  Zofran, has also been linked to craniosynostosis.

Craniosynostosis Complications

If left untreated, craniosynostosis can lead to numerous, severe medical complications for infants, including:

  • Seizures
  • Brain damage
  • Loss of eyesight
  • Speech and language problems
  • Permanent deformities
  • Breathing problems

Craniosynostosis and Mental Impairment

Another complication of craniosynostosis is the risk of infants developing cognitive and mental impairment issues. These issues may include problems with:

  • Attention span
  • Planning
  • Language development
  • Spelling
  • Reading

Physicians who’ve studied craniosynostosis indicate that mental impairment issues may arise from the infant brain malformation, as opposed to growth restriction of the brain.

Craniosynostosis Treatment Options

Treatment for craniosynostosis will depend on how severe the condition. For babies who only have mild suture problems, treatment may not be necessary as their heads will eventually grow normally.

However, for infants with more severe cases of craniosynostosis, surgery is the primary treatment method. Although thinking about your baby undergoing surgery might be frightening, it will help in the long-run by relieving pressure on the infant’s brain as well as create more room for the brain to grow.

There are two types of surgery for craniosynostosis: traditional surgery and endoscopic surgery. Traditional surgery entails making a small cut in the baby’s head in order to place the cranial bones in the correct shape. Physicians may insert screws to help keep the bones in place.

Endoscopic surgery entails using a lighted endoscopic tube, that’s inserted into small incisions made on the infant’s head, in order to help correct the medical issues. Endoscopic surgery is the least invasive of the two types of surgeries.

Zofran and Craniosynostosis

As mentioned earlier, pregnant women prescribed ondansetron run the risk of their babies developing craniosynostosis. However, GlaxoKlineSmith, the manufacturers of Zofran, may be responsible for your infant’s medical issues.

GlaxoKlineSmith continued to market Zofran as an off-label use for morning sickness even after reports indicated that it could potentially harm infants in utero. In turn, women who took Zofran while pregnant may be entitled to compensation for their infant’s medical expenses, pain, suffering, and more.

Not only has Zofran been linked to a heightened risk of babies developing craniosynostosis, but a host of other medical conditions as well. Other birth defects linked to Zofran include:

  • Cleft lip and palate
  • Musculoskeletal birth defects
  • Kidney defects
  • Heart abnormalities
  • Clubfoot and webbed fingers and toes
  • Problems with blood pressure
  • Neural tube defects

For more information on finding experienced legal representation to help you through this difficult time, refer to our article Zofran Lawyer.