A recent study has found evidence that pregnant women who use Zofran during the first trimester (three months) could be more likely to have a baby with oral clefts.

Zofran and Cleft Lip

The anti-nausea drug Zofran (ondansetron) is often taken by pregnant women to prevent morning sickness, though it is not approved for this purpose.

A study published in Birth Defects Research in January 2012 found that pregnant women who used Zofran were 2.4-times more likely to have a baby with a cleft palate. The results were based on data from 9,000 pregnancies between 1997-2004 in the National Birth Defects Prevention Study.

What is Cleft Lip?

Cleft lip, also known as “cheiloschisis,” is a birth defect that involves a split in the upper lip. It can also occur with cleft palate, which is a split in the roof of the mouth.

How common is cleft lip?

Cleft lip is the fourth most common birth defects, estimated to affect 1 in 700 births in the United States. The Centers for Disease Control (CDC) estimates that about 4,440 babies are born with a cleft lip in the U.S. every year.

What causes cleft lip?

In many cases, no one knows what causes a cleft lip. Some children have genetic abnormalities. Experts believe cleft lip may be caused by a combination of genes and environmental factors, such as what medications the mother uses during pregnancy.

For example, studies have found that pregnant 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 or cleft palate.

How is cleft lip diagnosed?

Cleft lip can be diagnosed when the baby is born, or during pregnancy. Many cases are diagnosed with an ultrasound, which is a medical test that uses sound waves to create an image of a baby in the womb.

When does cleft lip occur?

Cleft lip occurs during the first trimester (three months), around the 7th week of pregnancy. All fetuses begin life with a cleft lip and a cleft palate, but tissue normally closes the gap before the end of the first trimester.

What are possible complications of cleft lip?

  • Feeding problems
  • Malnutrition
  • Trouble speaking clearly
  • Slow language development
  • Ear infections
  • Hearing problems
  • Fewer teeth
  • Dental problems
  • Self-esteem issues from physical difference

What is the treatment for cleft lip?

There are many effective treatment options for cleft lip. Surgery is usually recommended during the first few months of life to improve the baby’s physical appearance, breathing, hearing, speech, and language development. In some cases, multiple surgeries are needed in the child’s first few years of life.

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