Cleft Lip and Palate Birth Defects


Women who take an antidepressant in the early stages of pregnancy increase the risk of their babies having facial malformations, including cleft lip and cleft palate.

Although selective serotonin reuptake inhibitors (SSRIs) often are considered the best standard of care when it comes to treating depression, researchers are finding an alarming number of birth defects are linked to the use of such prescription medicines during the first trimester. Scientists believe a lack of the chemical serotonin can be one of the factors that trigger depression, and these drugs essentially maintain higher levels of serotonin in the brain.

But exposure to antidepressants can inhibit fetal growth, especially in the first two months when the baby’s head forms. During this process, the upper lip develops before the palate, or roof of the mouth. When an antidepressant crosses the placenta and interferes with the normal growth of a fetus, it can result in a cleft lip or cleft palate, facial gaps that are produced when structures do not fully fuse.

About one in 594 babies per year in the United States – a total of more than 6,800 children – will be born with a cleft lip or cleft palate, according to Cleft Palate Foundation. About half the time, babies with one of these malformations have the other as well. A case study of SSRIs from 2011 reported links from that class of drugs taken during the first trimester of pregnancy to birth defects related to serotonin-related genes. Cleft palate is one of those related defects.

Among the most-prescribed SSRIs are Celexa (manufactured by Forest Laboratories), Cymbalta (Eli Lilly), Effexor (Wyeth Laboratories/now Pfizer), Lexapro (Lundbeck/Forest Laboratories), Paxil (GlaxoSmithKline), Prozac (Eli Lilly), Remeron (Organon), Symbyax (Eli Lilly), Wellbutrin (GlaxoSmithKline) and Zoloft (Pfizer).

As much as antidepressants may help mothers, they are not considered safe for babies. The U.S. Food and Drug Administration (FDA) has assigned most antidepressants a "C" grade, meaning they have been shown to harm animals taking them in large doses, but the effects on unborn humans are unproven.

The FDA warns pregnant women not to take Paxil after the drug was downgraded to D (from C). Class D are shown to be a risk to a human fetus.

Cleft Lip

A cleft is the gap left when parts of a fetus do not fully form and fuse together. A cleft lip (cheiloschisis) occurs on the upper lip and can vary in size, even extending all the way to the nose.

The cleft can be a single groove or even be bilateral gaps on each side of the lip. This type of deformity can cause delays in speech and language as well as problems with socialization that are inherent with any major physical deformity.

Cleft Palate

A cleft palate (palatoschisis) is the split that forms when the roof of a baby's mouth does not grow together. It can be as small as a hole on the roof of the mouth (the palate) or as large as the entire palate and jaw. Cleft palate can interfere with feeding, speech and breathing. Ear infections and hearing loss also are possible with this deformity.

Diagnosis and Treatment

Routine ultrasounds performed during pregnancy sometimes can reveal the orofacial clefts. It is more common, however, for the deformities to be discovered only after birth, necessitating treatment.

If a baby is born with cleft lip, cleft palate or the combination of both, the infant's parents can expect a schedule of multiple surgeries, often beginning before the child is three months old. Because a complete cleft palate affects the child's teeth and jaw, a bone graft is needed to close the split and extensive orthodontic and dental care is necessary after the surgeries.

Cleft lip and cleft palate both affect a child's appearance significantly prior to surgery. Even after surgery, speech and hearing problems are common, although they can be overcome with physical therapy and sometimes with additional surgeries. Psychological issues are also a concern during the rehabilitation phase and should not be overlooked.

Antidepressants and Other Side Effects

Defective cleft palates and cleft lips are among many birth defects linked by research to the use of antidepressants during pregnancy. Others include serious heart and lung defects, respiratory distress, anencephaly and neural tube defects.

Because of the numerous risks, the FDA listed Celexa, Effexor, Lexapro, Paxil, Prozac, Wellbutrin and Zoloft in January 2012 among its Top 10 medications that should be avoided by pregnant women. The agency came to that conclusion after multiple tests, experiments and surveys.