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Zofran Cleft Lip


When Zofran is used “off-label” to treat nausea and vomiting during the first trimester of pregnancy, it could increase the risk of having a baby with oral clefts.

Zofran and Cleft Lip

One of the largest studies linking Zofran and birth defects was published in Birth Defects Research in January 2012.

Children with cleft palate in the study were 2.37-times as likely to have mothers reporting the use of Zofran during the first three months of pregnancy, compared to children without birth defects. The conclusions were based on data from about 9,000 pregnancies in the National Birth Defects Prevention Study.

What is Cleft Lip?

Cleft lip is a split in the upper lip. It is a congenital birth defect that occurs around the 7th week of pregnancy, when tissue fails to grow together to form the upper lip. Some cases also involve the roof of the mouth, which can cause cleft palate.

How Common is Cleft Lip?

The Centers for Disease Control (CDC) estimates that about 4,440 babies are born with cleft lip every year in the United States, or about 1 in every 700 births. It is the fourth most common birth defect.

What Causes Cleft Lip?

Experts believe a combination of genetic (hereditary) and environmental risk-factors cause cleft lip. For example, studies have found that women who use the anti-seizure drug Topamax (topiramate) during the first trimester are 20-times more likely to have a baby with cleft lip.

Feeding Problems

Babies with a cleft lip, but no cleft palate, can usually breastfeed normally. If the baby cannot form a suction on the breast due to air escaping from a cleft, they are at risk of feeding problems and malnutrition. In many cases, they need to use a special bottle.


  • Malnutrition
  • Frequent ear infections
  • Hearing problems
  • Speech and language delays
  • Need for special orthodontics
  • Fewer teeth
  • Dental problems
  • Physical differences
  • Low self-esteem


Many children with cleft lip are diagnosed before they are even born, using an ultrasound. This test involves high-frequency sound waves to make a picture of a growing fetus in the womb.


Surgery is recommended before the child is 18 months old, and usually in the first 12 months. This can help improve the child’s physical appearance and reduce the risk of complications affecting speech, language, and hearing. Some children with severe clefts need multiple reconstructive surgeries. Even in severe cases, long-term prognosis is very good.

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