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Zofran Cleft Palate


New research suggests that cleft palate may be twice as likely to occur in babies who are exposed to Zofran during the first three months in the womb.

Zofran and Cleft Palate

January 2012 — The journal Birth Defects Research has published a study linking the use of Zofran during the first trimester of pregnancy with a 2.37-fold increased risk of cleft palate.

Researchers from the Slone epidemiology unit and the Centers for Disease Control (CDC) based their conclusions on more than 9,000 pregnancies between 1997 and 2004. The data was compiled in the National Birth Defects Prevention Study.

What is Cleft Palate?

The term cleft palate literally means “split in the roof of the mouth.” The cleft connects the baby’s mouth to the nasal cavity. It may involve the hard palate and/or soft palate, bones of the upper jaw, teeth, and gums. Some clefts also involve the upper lip, resulting in a cleft lip.

A rare type of cleft palate, known as submucous cleft palate, involves a gap in the roof of the mouth that is covered by a mucous membrane. Some people with this cleft are never diagnosed, and their only symptom is a nasal-sounding voice.

Cleft Palate and Pregnancy

Cleft palate occurs during the first trimester, around the 10th week of pregnancy, when tissue fails to grow together to form the roof of the mouth.

How Common is Cleft Palate?

Cleft palate is one of the most common birth defects, estimated to affect about 1 in 970 babies, but it is less common than cleft lip. About 2,650 babies are born with cleft palate in the United States every year.


There are many risk-factors for cleft palate, but no one knows exactly what causes it. The birth defect runs in some families, suggesting a genetic component. However, many environmental factors also increase the risk. For example, about 20% of cleft palate birth defects are associated with smoking cigarettes. Medications, exposure to toxic substances, and food that a pregnant woman eats can all lead to cleft palate.

Complications of Cleft Palate

Feeding problems are a common complication of cleft palate, especially for newborns. Air escapes through the cleft and makes it impossible to suck on a nipple or breast. Babies with cleft palate may need to feed with a special bottle, or a nasogastric tube in rare cases.

Other complications of cleft palate:

  • Problems swallowing (dysphagia)
  • Delays in speech and language development
  • Ear infections
  • Hearing problems
  • Nasal-sounding speech
  • Missing teeth
  • Orthodontic or dental problems
  • And more

Treatment for Cleft Palate

Children who are born with cleft palate often undergo a complex, lengthy treatment plan lasting until adulthood. The first surgery is recommended between the ages of 9-18 months, but some children need revision surgery and orthodontic implants or bridges. During school-age years, they may need routine visits to assess hearing, speech, and language development.

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