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Ever since Zofran (ondansetron) has been marketed as off-label use for morning sickness for pregnant women, numerous infants are being born with severe birth defects. One birth defect associated with Zofran use, craniofacial defects (also known as craniofacial abnormalities), is a debilitating condition that usually requires surgery and a host of other treatments.

What Are Craniofacial Birth Defects?

According to the Centers for Disease Control and Prevention (CDC), craniofacial defects are medical conditions that arise at birth, and entail improper forming of an infant’s face and/or skull. There are two common types of craniofacial birth defects, including orofacial clefts and  craniosynostosis.
Craniofacial birth defects

Orofacial Clefts

Orofacial clefts, also known as cleft lip and cleft palate, occur when an infant’s mouth or lip fail to develop properly. Infants’ lips begin to form  between the 4th-7th week of pregnancy, yet if the tissues fail to form properly, the result is the baby being born with an opening in the upper portion of the lip.

The roof of an infant’s mouth forms between the 6th-9th weeks pregnancy. If the tissue that connects the roof of the mouth fails to form properly, a baby is born with a cleft palate, an opening in the mouth’s roof.

Over 2,000 babies are born each year with a cleft palate, and more than 4,000 infants are born each year with a cleft lip (sometimes with a cleft palate as well). CDC suggests they are some of the most common types of birth defects in the United States.

Infants born with orofacial clefts often have a difficult time with eating and drinking. They can also have issues with ear infections and as they grow older, issues with speaking clearly. Depending upon how severe the problem is, infants may need to undergo surgery within the first 12 months of life. Additionally, they may need long-term medical care and often face issues with self-esteem, which may require counseling services.


Craniosynostosis is a birth defect marked by one or several joints between an infant’s closing before the brain has fully formed. Consequently, the brain continues to grow and results in the head taking on an uneven shape.

Infants born with craniosynostosis are a heightened risk of developing severe medical complications, including:

  • Brain damage
  • Seizures
  • Difficulties with breathing
  • Permanent head deformations
  • Delays in speech and language development

Treatment for craniosynostosis consists primarily of traditional surgery or endoscopic surgery, in which a lighted endoscope tube is inserted in the baby’s skull area via small incisions.

Craniofacial Birth Defects Causes

Although there isn’t always a known cause when an infant develops craniofacial birth defects, there are certain risk factors that may contribute to a heightened chance of babies developing the disorders, including:

  • Smoking
  • Maternal obesity
  • Maternal thyroid problems
  • Taking certain medications while pregnant

Zofran Linked to Craniofacial Birth Defects

Numerous recent studies have linked the use of Zofran by pregnant women with a heightened risk of their babies developing craniofacial defects. For instance, a 2012 study published by National Institutes of Health (NIH) indicates that unborn infants exposed to Zofran (which travels to the placenta once consumed) are twice as likely to develop cleft lip and/or cleft palate.

A 2013 study published by the New England Journal of Medicine states that not only are unborn infants who are exposed to Zofran at a heightened risk of developing craniofacial birth defects, but they are also at risk of developing life-threatening congenital heart defects.

What To Do If Your Infant Was Born with Craniofacial Birth Defects

If you were prescribed Zofran while pregnant and your baby developed birth defects, it’s important to obtain legal representation from an experienced Zofran lawyer who can help you. Medical costs associated with caring for a baby with birth defects can be long-term and much more expensive the average family can afford. You may be entitled to compensation for medical bills, any medical-related travel expenses, counseling and physical therapy service, lost wages, special education costs and much more.