Recently, information has emerged regarding the link between the maternal use of certain prescription medications and the development of cleft palate in babies born to these women. Cleft palate is a rare orofacial defect that occurs when the tissue that forms along the roof of the mouth doesn’t join together properly in the womb. Drug-induced clefts may appear as a small notch in the lip, or can extend from the lip through the upper gum and palate into the bottom of the nose.

Cleft Palate Lawsuit Review: If you or somebody you know has a child who was born with cleft palate after being exposed to a prescription drug in the womb, you should contact our lawyers immediately. Consultations are always free. Please use our confidential email contact form or call toll free 24 hrs/day by dialing (866) 588-0600.

Which prescription medications have been linked to cleft palate?

According to numerous medical journals and FDA reports, a number of popular antidepressant and epilepsy drugs have been found to increase the risk of cleft palate and other birth defects in babies born to mothers who took the drugs during pregnancy (especially during the first trimester, a time when many women may still be unaware they are pregnant). Prescription medications associated with cleft palate include:

  • Paxil (paroxetine)
  • Zoloft (sertraline)
  • Celexa (citalopram)
  • Prozac (fluoxetine)
  • Lexapro (escitalopram)
  • Symbyax (fluoxetine and olanzapine)
  • Wellbutrin (bupropion)
  • Effexor (venlafaxine)
  • Depakote
  • Depakote CP
  • Depakote ER
  • Depakene
  • Valproate Acid
  • Divalproex Sodium
  • Topamax (topiramate)

Cleft Palate Overview

Cleft palate is a treatable congenital birth defect that occurs when the roof of the baby’s mouth (palate) fails to develop normally in utero, leaving an opening (cleft) in the palate that may pass through the nasal cavity. A drug-induced cleft can form on any part of the palate, including the front part of the roof of the mouth (hard palate) or the small flap of tissue that hangs down from the soft palate (uvula). It may occur alone or be accompanied by other orofacial birth defects such as cleft lip.

Cleft palate occurs in approximately one to two of every 1,000 live births in the United States each year, making it among the most commonly reported birth defects involving the head and neck. For reasons still unclear, oral cleft defects tend to occur most often in the children of Asian, Latino, and Native American descent.

Orofacial clefts typically fall into three broad categories:

  1. Cleft lip without a cleft palate
  2. Cleft palate without a cleft lip
  3. Cleft lip and cleft palate together

Cleft lip with or without cleft palate is typically more common among boys, while cleft palate alone is more common in girls than boys.

Signs & Symptoms

A drug-induced cleft palate is typically identifiable immediately after birth, and may occur on one or both sides of the roof of the mouth. It may also run the full length of the palate. Signs and symptoms include:

  • change in nose shape (how much the shape changes varies)
  • poorly aligned teeth

Complications that may arise because of a congenital cleft palate may include:

  • failure to gain weight
  • feeding problems
  • flow of milk through nasal passages during feeding
  • poor growth
  • repeated ear infections
  • speech difficulties

Expectations (Prognosis)

The vast majority of babies born with cleft palate will heal without problems once the issue has been corrected. The child’s appearance after healing depends on the severity of the original defect. He or she may require additional surgeries to repair the scar from the wound.

Patients who have undergone cleft palate repair may require regular appointments with a dentist or orthodontist because the teeth may need to be corrected as they come in. Additionally, hearing problems are commonly reported in children with cleft palate. Hearing tests are typically performed early on in life, and should be repeated periodically over time. Cleft palate babies may also have problems with speech caused by muscle deformities in the palate. Speech therapy can be a tremendous help in this department.

Is there a time limit in filing a cleft palate lawsuit?

Although we encourage all our potential clients to take great care in selecting their cleft palate lawyer, it is important that you understand that time is of the essence. The applicable statute of limitations in your state may time bar your claim. Furthermore, we are unable to provide you with legal advice without first evaluating your potential case. Accordingly, please take the time now to contact us by using the confidential email contact form below or by calling us toll free 24 hrs/day by dialing (866) 588-0600.

We hope we will be able to assist you with your potential cleft palate birth defects lawsuit and look forward to speaking with you.


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