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Cleft lip and cleft palate are the most common birth defects associated with Zofran (ondansetron). In most instances, women who take Zofran during the first trimester are at the highest risk of having a baby with cleft lip and cleft palate birth defects, as the early weeks of pregnancy are the most crucial for development.

What is Cleft Lip and Cleft Palate?

According to the Centers for Disease Control and Prevention (CDC), cleft lip and cleft palate are types of birth defects that happen when an infant’s lip (usually upper) and/or mouth do not form correctly during their mother’s pregnancy.
baby with cleft lip
An infant’s lips begin to form anywhere between the 4th and 7th week of pregnancy, an extremely important time for infant development. If the baby’s lip tissues fail to form properly during this time, the result is cleft lip, which is generally detected after the infant is born, marked by a clear opening in the upper lip. The size of the opening can range from small to large and usually forms in the middle of the top lip.

Cleft palate occurs when the roof of the baby’s mouth fails to join together properly. The roof of the mouth (palate) can form anywhere from the 6th to the 9th week of pregnancy. In some cases, only the part of the roof amount fails to form, whereas in other instances, the the front and the back of the roof of the mouth are open.

How Often Does Cleft Lip and Cleft Palate Occur?

CDC suggests that around 4,440 infants are born in the U.S. each year with cleft lip. Around 2,650 infants are born in the U.S. each year with cleft palate.

Cleft issues are the 4th most common type of birth defect, and infant boys are twice as likely to develop these issues when compared to infant girls.

Cleft Lip and Cleft Palate Problems and Treatment Options

Infants born with cleft lip and cleft palate have an extremely difficult time with feeding. Additionally, they are a heightened risk of ear infections, teeth problems, and later on, speaking clearly.

Treatment options for cleft lip and cleft palate generally consist of surgery within the first few months of life. Depending upon the severity, additional surgery may be needed later on. Orthodontic services and speech therapy may be required to help with speech difficulties, breathing, and development of language.

Zofran Linked to Cleft Lip and Cleft Palate

In 2012, the CDC, along with Boston’s Slone Epidemiology Center, published the results of a study performed on the birth defects and pregnant women who took Zoloft (also known as Zuplenz). According to the study, which investigated and reviewed over 9,000 live births in the U.S., pregnant women who take Zofran during pregnancy, specifically during the first trimester, double their chances of having a baby with cleft palate.

The study also states that many of the women researched in the study did not have any genetic or hereditary factors that would have caused cleft lip and cleft palate.

The U.S. Food and Drug Administration’s (FDA) database also lists numerous other birth defects associated with taking Zofran while pregnant, including:

  • Jaundice
  • Heart abnormalities
  • Kidney malformations
  • Death, and more

Other Reasons Cleft Lip and Cleft Palate May Occur

Other factors have been contributed to infants developing cleft lip and cleft palate, including:

  • Maternal smoking
  • Maternal diabetes
  • Genetic factors
  • Environmental factors

In some cases, the cause of cleft lip and cleft palate are unknown.

Did You Take Zofran While Pregnant?

Keep in mind that if you took Zofran while pregnant and your baby was born with cleft lip or cleft palate, you have the legal right to file for damages. GlaxoSmithKline, the makers of Zofran, promoted the medication as off-label use for morning sickness, even though it’s only intended for cancer patients to help battle nausea and vomiting after chemotherapy and other treatments.

For more information, on previous GlaxoSmithKline cases, refer to our article, GlaxoSmithKline Lawsuits.