Cleft lip and cleft palate are birth defects characterized by the malformation of the mouth when there is not enough tissue in the mouth during early fetal development.[1]  This may occur either in the lip alone, in the roof of the mouth, or in both.  In cleft lip, the upper lip is split and divided.  In babies with cleft palate, there is a “split or opening in the roof of the mouth.  A cleft palate can involve the hard palate (the bony front portion of the roof of the mouth), and/or the soft palate (the soft back portion of the roof of the mouth).”[2]

Prominent child health website provides these helpful images for better understanding:

Prozac Lawyer Celexa Lawyer SSRI Birth Defect Lawsuit SSRI Attorney - Cleft Palate -

If left untreated, though most cleft lips or cleft palates are treated soon after birth, many problems may be associated with cleft palate, such as:

“Eating problems. With a separation or opening in the palate, food and liquids can pass from the mouth back through the nose. Fortunately, specially designed baby bottles and nipples that help keep fluids flowing downward toward the stomach are available. Children with a cleft palate may need to wear a man-made palate to help them eat properly and ensure that they are receiving adequate nutrition until surgical treatment is provided.

Ear infections/hearing loss. Children with cleft palate are at increased risk ofear infections since they are more prone to fluid build-up in the middle ear. If left untreated, ear infections can cause hearing loss. To prevent this from happening, children with cleft palate usually need special tubes placed in the eardrums to aid fluid drainage, and their hearing needs to be checked once a year.

Speech problems. Children with cleft lip or cleft palate may also have trouble speaking. These children’s voices don’t carry well, the voice may take on a nasal sound, and the speech may be difficult to understand. Not all children have these problems and surgery may fix these problems entirely for some. For others, a special doctor, called speech pathologist, will work with the child to resolve speech difficulties.

Dental Problems. Children with clefts are more prone to a larger than average number of cavities and often have missing, extra, malformed, or displaced teeth requiring dental and orthodontic treatments. In addition, children with cleft palate often have an alveolar ridge defect. The alveolus is the bony upper gum that contains teeth. A defect in the alveolus can (1) displace, tip, or rotate permanent teeth, (2) prevent permanent teeth from appearing, and (3) prevent the alveolar ridge from forming. These problems can usually be repaired through oral surgery.”[3]

Cleft Lip and Cleft Palate Associated with Maternal SSRI Use

It has recently been documented that a factor that increases the risk of a child being born with cleft lip or cleft palate is maternal use of SSRI drugs during pregnancy.  “SSRI” stands for selective serotonin reuptake inhibitor, a type of medication that regulates the concentration of serotonin, a type of chemical called a neurotransmitter, a chemical messenger in the brain that helps regulates mood, appetite, and the sleep cycle.

In 2007, Carol Louik et al. documented that if a pregnant mother-to-be used any SSRI, the risk for her baby being born with a cleft lip, with or without cleft palate as well, was raised by 50%.[4]

If an expecting mother used fluoxetine (Prozac®), the risk was found to be raised by 80% compared to the rate among infants whose mothers did not use SSRIs during pregnancy.[5]  Another specific drug associated with an increased risk for cleft palate was citalopram (Celexa®), increasing the risk for cleft palate over three times that in the general population,[6] which is normally about 1 in 2500 babies.[7]

Louik’s startling findings published in The New England Journal of Medicine show us that though cleft lip may not be able to be avoided entirely, there are ways to avoid unduly increased risk of your baby being born with this birth defect.

Treatment and Outlook for Cleft Lip and Cleft Palate

Thankfully, there are ways to treat cleft lip and cleft palate if your baby is born with the ailment.  PubMed Health, a service of the United States National Library of Medicine, states that “Surgery to close the cleft lip is often done when the child is between 6 weeks and 9 months old. Surgery may be needed later in life if the problem has a big effect on the nose area.”[8]

“A cleft palate is usually closed within the first year of life so that the child’s speech develops normally. Sometimes a prosthetic device is temporarily used to close the palate so the baby can feed and grow until surgery can be done.”[9]

PubMed Health continues, reassuring that “Most babies will heal without problems.”[10]


Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.

[1] “Cleft lip and palate – PubMed Health” PubMed Health. U.S. National Library of Medicine. © 2012 A.D.A.M., Inc. Available at <> Last Reviewed 1 May 2011, Accessed 31 January 2013.

[2] “Cleft Lip and Cleft Palate: Causes and Treatments” WebMD. © 2005-2013 WebMD, LLC. Available at <> Accessed 31 January 2013

[3] Ibid.

[4] Louik, C. et al. (2007) “First-Trimester Use of Selective Serotonin-Reuptake Inhibitors and the Risk of Birth Defects” The New England Journal of Medicine Vol. 365, No. 26; pp. 2675-2683

[5] Ibid.

[6] Ibid.

[7] “Cleft lip and palate – PubMed Health” PubMed Health. U.S. National Library of Medicine. © 2012 A.D.A.M., Inc. Available at <> Last Reviewed 1 May 2011, Accessed 31 January 2013.

[8] Ibid.

[9] Ibid.

[10] Ibid.