Cleft Palate & Cleft Lip

According to a 2004 systematic review, 12 percent of women suffer from clinical depression during the second and third trimesters of pregnancy. The March of Dimes estimates that as many as one in five women have symptoms of depression while expecting, and that for some patients, symptoms are severe.

Selective serotonin reuptake inhibitors (SSRIs) are a class of antidepressants that help balance the neurotransmitters in the brain, easing the symptoms of depression. However, many scientific studies have linked the use of these medications during pregnancy with a higher risk of giving birth to newborns with birth defects, including cleft palate and cleft lip.

Women and their health care providers are best advised to work together in deciding how to treat depression during pregnancy. Some women may be able to find other solutions for their symptoms. Those who choose to use an SSRI antidepressant should first be aware of the potential risks.

Cleft palate and cleft lip overview

A cleft lip and palate occur when a baby’s lip or mouth do not form properly in the womb. The medical term for each is “cheiloschisis” (cleft lip) and “palatoschisis” (cleft palate). According to the National Institutes of Health, about one in every 700 newborns suffers from this birth defect, which can typically be corrected with surgery.

• Cleft lip: During the fourth and seventh weeks of pregnancy, the lip forms on the fetus. If the tissue that makes up the lip doesn’t join as it’s supposed to before birth, the child will be born with an opening in the upper lip. It may range from a small slit, called a “partial” or “incomplete cleft,” to a large opening that reaches through the lip and into the nose, called a “complete cleft.”
• Cleft palate: The roof of the mouth, called the palate, forms between the sixth and ninth weeks of pregnancy. It has two parts—the hard and soft. The hard part is made of bone and is toward the front of the mouth, while the soft is made up of muscle and tissue toward the back of the mouth. If the skull or the tissue that makes up the roof of the mouth does not join together correctly, the newborn will be left with an opening between the roof of the mouth and the nose. The severity of the cleft depends on which part of the palate it effects—the hard or soft.

Babies may be born with either a cleft lip or cleft palate, or may have both at once.

What are the signs of cleft lip and palate?

These birth defects are usually discovered after the baby is born, though sometimes they can be detected with an ultrasound before delivery.

If the cleft is not readily visible, the child may show other signs, such as:

• Difficulty feeding
• Chronic ear infections
• A tone of voice as if talking through the nose (for clefts that are found years later)

Other complications that may develop because of these defects may include hearing loss, speech and dental problems.

Treatment options

Surgery typically repairs both cleft lip and palate, and is usually performed before 12-18 months of age. With treatment, most children are able to lead a healthy life, though they may need additional surgeries, dental, or orthodontic care as they get older.

SSRIs and cleft palate

SSRIs have been linked with an increased risk of birth defects since 2006, when the FDA warned patients and physicians that taking the medications during pregnancy could increase the risk of giving birth to newborns with persistent pulmonary hypertension of a newborn (PPHN), a serious lung defect. They based this warning on a scientific study published in the New England Journal of Medicine that year.

That same year, a Danish population-based cohort study published in Epidemiology reported that women taking SSRI antidepressants from 30 days before conception to the end of the first trimester were more likely to give birth to babies with congenital formations, which may include cleft lip and palate.

An earlier Canadian study published in CMAJ also found a link between the use of paroxetine (Paxil) during pregnancy and an increased risk of malformations in the newborn. In 2007, another study published in the New England Journal of Medicine found that some SSRIs may cause an increased risk of some birth defects, while a second study published that same year in the same journal found associations between SSRI use and three types of birth defects, including skull, abdominal, and neural tube defects.

FDA warns about antidepressants and pregnancy

The FDA has taken some steps over the years to warn patients and physicians of the potential for SSRI birth defects. As mentioned, in 2006 they issued a public safety communication about the potential for the drugs to increase risk of PPHN, but they revised that warning in 2011 due to “conflicting findings” in studies. Another study published in 2012 offered more evidence linking SSRIs to an increased risk of PPHN.

In October 2012, Human Reproduction published a study in which researchers warned that SSRIs may be too risky for pregnant women or those who planned on becoming pregnant. The study linked the drugs with an increased risk of miscarriage, preterm birth, PPHN, and other birth defects. They also questioned the use of the drugs, stating, “There is no evidence of improved pregnancy outcomes with antidepressant use.” They recommended cognitive therapy as a potentially better alternative.

Mothers who have given birth to children with birth defects like cleft lip and cleft palate may be eligible to file a lawsuit against the makers of the SSRI antidepressants. Potentially risky SSRIs may include:

• Celexa (citalopram)
• Lexapro, Cipralex (escitalopram)
• Paxil (paroxetine)
• Prozac (fluoxetine)
• Luvox (fluvoxamine)
• Zoloft (sertraline)