A study has found an increased risk of cleft palate associated with Zofran, an anti-nausea drug that is commonly used “off-label” to treat morning sickness in pregnant women.

Zofran and Cleft Palate

The study, published in Birth Defects Research, analyzed a database of pregnancies for over 30 different birth defects. The study included 9,000 pregnancies between 1997 and 2004.

They found that women who reported using Zofran during the first trimester were 2.37-times more likely to have a baby with cleft palate compared to women who did not use Zofran.

What is Cleft Palate?

The term “cleft” means a split or divide. Children who are born with cleft palate have a gap in the roof of their mouth (“hard palate” and “soft palate”). It may occur on one or both sides of the palate. The gap may also include bones in the upper jaw, teeth, and gums. Some children also have a cleft lip.

Another type of cleft palate is called submucous cleft palate, in which the roof of the mouth is split but it is covered with a mucous membrane. Many cases do not need treatment and are never diagnosed.

When Does Cleft Palate Occur During Pregnancy?

Cleft palate occurs around the 10th week of pregnancy, during the first trimester (three months).


Usually, cleft palate is diagnosed at birth, although some cases are diagnosed before the baby is born using an ultrasound. It may not be noticed until the baby has problems feeding and swallowing.

Feeding Problems

Babies with a small or narrow cleft palate usually do not have problems breastfeeding. However, some babies have problems forming suction on a breast or nipple due to air escaping through the cleft. The baby may need to be fed using a bottle with a special nipple. Very rarely, it is necessary to feed the baby using a combination of a nasogastric tube and a bottle during the first two months of life.

How Common is Cleft Palate?

Cleft palate occurs in about 1 in 970 births in the United States. It is less common than cleft lip. According to the Centers for Disease Control (CDC), about 2,650 babies are born with cleft palate every year.

What Causes Cleft Palate?

The cause of cleft palate in most babies is unknown. Oral clefts are more common in some families. Experts believe a combination of genetic and environmental risk-factors probably cause cleft palate, but no knows. Environmental risk-factors include smoking cigarettes, toxic substances, medications, or food eaten during pregnancy.


  • Trouble feeding or swallowing (dysphagia)
  • Speech and language delays
  • Nasal sounding speech
  • Frequent ear infections
  • Hearing problems
  • Dental, upper jaw, or orthodontic problems
  • Fewer teeth than normal

Treatment of Cleft Palate

Surgery for cleft palate is usually done between 9 and 18 months of age. Children with severe clefts often need multiple surgeries as they grow older, speech therapy, hearing assessments, or special orthodontics (dental implants and bridges). With treatment, long-term prognosis is very good.

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