Cleft Lip and Cleft Palate Birth Defects Linked To Zofran

Cleft Palate and Cleft Lip (also known as Orofacial Clefts) are very common birth defects that occur early in a pregnancy. In a normal pregnancy the tissues that form the lip and mouth fuse within weeks 8 and 12. When these tissues either partially or completely fail to fuse, a cleft lip and/or a cleft palate occurs.

A baby can be born with a cleft palate or a cleft lip independently of each other. There are also many instances where a baby can be born with both a cleft lip and a cleft palate, and they can occur on one side of the mouth, known as a unilateral cleft, or both sides, known as a bilateral cleft.

The Link Between Zofran And Cleft Palate / Lip

Zofran was promoted by GSK from 1991 as a drug that is not unsafe for pregnant women to take in treating morning sickness. There were no warnings by GSK regarding Zofran being taken by pregnant women. Since 1991, instances of birth defects were reported in mothers who had no family or genetic predisposition to cleft palate or cleft lip. Several epidemiological studies were performed to assess whether Ondansetron (the active drug in Zofran) had a causal link where ingestion within the first trimester increased the risk of a cleft palate, lip and other child birth defects

Does taking Zofran in the first trimester double the risk of a cleft palate?

According to a study in 2012 by the Centers For Disease Control and the Sloan Epidemiology Center, taking Zofran during the first trimester of pregnancy lead to doubling the risk of a child being born with a cleft palate. The study reviewed more than 9,000 births in the US. For more information click here.

What is a Cleft Palate?

A Cleft Palate pertains specifically to the roof of the mouth. Here, the skin tissue fails to fuse and results in a split of the roof of the mouth. Cleft Palates can be a soft or hard cleft palate. A soft cleft palate involves the soft skin at the back of the roof of the mouth. A hard cleft palate is where the separation occurs in the front of the roof of the mouth where there tends to be more bone.

What is a Cleft Lip?

A Cleft Lip is where a relatively narrow portion of skin tissue fails to form in the upper lip. This cleft or gap extends from the upper lip beyond the base of the nose. Some cases involve issues of the upper jaw and upper gum.

A Cleft lip is the fourth most common birth defect, affecting 1 in 700 babies.

What Causes Cleft Lip and Cleft Palate?

There are two accepted causes of cleft lip and cleft palate.

  1. It is hereditary as a genetic predisposition; and
  2. The conditions are caused by some external factors such as a drug taken by the mother during pregnancy, like Zofran. There have also been links to a higher probability of this birth defect in mothers who smoke during their pregnancy, or have diabetes.

There have been strong links between the following drugs which increase the risk of cleft lip and cleft palate:

  • Methotrexate – for treating cancer, arthritis, and psoriasis
  • Accutane – a drug for treating acne
  • Anti-seizure / anticonvulsant drugs
  • Antidepressants
  • Zofran – promoted as a drug for hyperemesis gravidarum or morning sickness

When Is A Cleft Lip or Cleft Palate Detected / Diagnosed?

As part of the pregnancy process ultrasounds will be performed. Typically a cleft lip will be detected by the ultrasound. However in some instances, the diagnosis will occur at child birth by way of a visual examination of the lip and mouth.

There are other forms of cleft palate that are not diagnosed until later in life.

What Problems Are Caused By Orofacial Clefts?

Whether your baby has a cleft lip and/or cleft palate, they will likely be faced with the following medical and growth complications:

Eating & Nutrition Issues

Breastfeeding, and ingesting important nutrition at a time when development is crucial is compromised by a cleft lip and/or cleft palate. The cleft allows the formula / food to pass through the cleft and causes difficulties for the child to get the right amount of nutrition.

Until surgical treatment is provided, a baby with a cleft can use specifically designed bottles and mouth guards to assist in the feeding process.

Hearing Problems & Infections

Studies have shown that a cleft enables fluid to build up in the “middle ear” which is the cause of an ear infection. When such infections are left untreated they cause hearing loss. Procedures are available for placing drainage tubes in the ear to prevent such fluid buildup. People who had a cleft lip or cleft palate are required to have annual hearing tests as a long-term precaution.

Issues With Speech

Another common issue with a cleft palate and/or cleft lip is a speech problem. Speech is generated by a) power from your lungs, b) vibration from your voice box, and c) the resonator, which comes through your throat, nose, mouth, and sinuses. As a result of the orofacial cleft the resonator is effected due to the cleft in the mouth through the nose. The result in most clefts is that the child’s voice does not carry well, making it difficult to understand. Surgery may repair this problem, however in some cases, a speech pathologist is required to work with the child.

Dental Issues

Another unfortunate consequence of a cleft lip or palate is that there is a much higher incidence of cavities, and dental deformities such as missing, extra, and displaced teeth. This leads to several dental procedures that someone without a cleft would not have to go through. These issues continue throughout the later years requiring expensive dental and orthodontic care.

What Procedures Exist To Repair Orofacial Clefts?

It is recommended by medical professionals that a cleft palate be surgically repaired within the first 18 months of life or as early as possible. This is specifically so that the child can be nourished properly and be given the best chance of a better quality of life. A cleft lip can be repaired surgically within the first 12 months of life.

It is likely that a child will require additional surgeries as they grow older and their mouth and facial structure grow and change. These surgical procedures are likely to improve the appearance of the face and potentially alleviate issues with speech, breathing and hearing.

A team that repairs cleft related issues is called a craniofacial team. However, given all of the outlined conditions that occur as the years pass, the number of medical professionals and support roles that come in to play is very large.

  • Plastic Surgeon – repair of lip and upper palate
  • Oral Surgeon – repositioning of the jaw and repair of gum cleft
  • Orthodontist – for straightening teeth
  • Otolaryngologist – also known as an ear, nose and throat specialist to determine hearing issue correction
  • Speech Pathologist – typically dealing with speech and eating
  • Audiologist – assessing hearing issues
  • Dentist – for dental care
  • Prosthodontist – for making oral appliances to improve speech and appearance
  • Speech Therapist
  • Nurse Coordinator – for supervising the health of the child
  • Social Worker – supporting the family
  • Geneticist – to evaluate problems in future pregnancies

Cleft Lip Repair

A cleft lip alone typically will require one surgery and is usually performed after the child is 3 months old.

Cleft Palate Repair

A cleft palate’s treatment plan is more complicated and extends over the course of 18-21 years, which will comprise several surgeries.

  1. The first surgical procedure typically takes place within the first year and involves making the palate functional, lowering the probability of fluid build up in the middle ears, and lay the foundation for proper facial bone formation, and dental development;
  2. Another surgery that is typical is a bone graft when the child is approximately 8 years old. This surgery provides a gum structure that will support permanent teeth;
  3. Braces are most often required once permanent teeth grow;
  4. Other Surgeries: 1 in 5 cleft palate patients will require even more surgeries for filling in gaps that develop, improving breathing and speech, and stabilizing the jaw; and
  5. One of the final surgeries is usually plastic surgery to remove the scar. This is not typically performed until 18 years old or more.
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