Topamax and Cleft Lip

Topamax is an anticonvulsant medication which was originally approved by the FDA in 1996 to prevent the seizures associated with epilepsy. The active ingredient in Topamax is topiramate, and the drug is used alone or in combination with other anti-seizure medications to treat partial onset seizures and primary generalized tonic-clonic seizures in adults and children. Topamax functions by inhibiting the firing of impulses in the brain which are responsible for triggering seizure-related episodes. In 2004, the FDA included an additional approval for Topamax to treat migraine headaches, which are extremely common among women of childbearing age, and the drug has since become one of the most popular forms of anticonvulsant treatment on the market. Unfortunately, despite the drug’s popularity, recent research has indicated a potential connection between the use of Topamax during pregnancy and an increased risk of birth defects in infants exposed to the drug in utero. Among these alleged Topamax birth defects is a craniofacial malformation called cleft lip.  Potential Topamax lawsuits for these birth defects may be soon to follow.

Cleft Lip Birth Defects Described

Cleft lip is an oral defect which may be a Topamax side effect, which affects the formation of the lip during the first five to six weeks of fetal development. Cleft lip typically presents as a vertical fissure on one or both sides of the upper lip and the degree of damage can vary from a small notch in the upper lip to a severe crevice in the lip which extends up through the nose. Cleft lip occurs when there is a lack of tissue in the upper lip, preventing the lip from fusing completely in utero.

Cleft Lip Treatment and Complications

In severe instances of cleft lip the child may require several surgeries, the first of which is typically performed during the first few months of the child’s life. Following these surgeries, children with cleft lip often benefit from long-term dental and orthodontic care in order to ensure complete recovery and to prevent further complications. In some cases, children with this defect will struggle with additional difficulties, including:

  • Eating issues
  • Recurring ear infections
  • Hearing loss
  • Speech and language delay
  • Misaligned teeth

Because infants with cleft lip may have a full separation between the mouth and the nose, it is possible for food and liquid to pass back from the mouth through the nose, resulting in serious feeding problems. Children with cleft lip are also more prone to having fluid build up in their ears, which may lead to chronic ear infections and potential hearing loss. A cleft lip may also result in missing or misaligned teeth, and problems with proper speech and language development.

Topamax Studies and Possible Link to Birth Defects

There have been two major studies recently published which have indicated a potential connection between the use of Topamax and birth defects like cleft lip. In 2008, a study was published in Neurology which reviewed 203 women who became pregnant while taking Topamax either alone or with another anti-seizure medication. Of the 178 live births studied by researchers, four infants were born with cleft lip or cleft palate, a percentage eleven times higher than the national average. In addition, four male children were born with genital defects like hypospadias, a percentage fourteen times higher than what is considered normal in women who don’t take anti-seizure medications during pregnancy.

According to data collected by the North American Antiepileptic Drug Pregnancy Registry, 1.4% of infants who are exposed to Topamax in utero may develop cleft lip or cleft palate. In comparison, 0.38-0.55% of infants exposed to other anticonvulsant drugs besides Topamax will be born with cleft palate or cleft lip, and 0.07% of infants whose mothers did not take anticonvulsant drugs while pregnant will develop one of these two craniofacial malformations. Even more telling is research indicating that the risk of infants being born with one or more birth defects like cleft lip is exponentially higher when Topamax is taken in combination with valproate, the active ingredient in the anticonvulsant drug, Depakote. According to the Neurology study, the birth defect rate was highest among women who took Topamax and valproate together.  Possible side effects of topiramate, the generic equivalent, are believed to be similar.

Topamax Use and Pregnancy

In response to these findings, the FDA increased the pregnancy category of Topamax from C to D, which means the drug has the potential to cause significant, unreasonable harm to a human fetus. The FDA also released a safety announcement warning patients and health professionals about the potential connection between Topamax use and craniofacial malformations like cleft lip and cleft palate. If you are currently taking Topamax and you are pregnant or planning to become pregnant, consult your physician immediately. It is never advised to discontinue use of a prescription medication without medical consent, as this may cause further adverse side effects, but with your doctor’s help you may be able to find an alternative treatment method to control your epilepsy.

Topamax Lawsuits for Cleft Lip Injuries

Research has suggested that Topamax may pose a serious risk for infants whose mothers take the anti-epileptic drug while pregnant. Unfortunately, because the public remains largely uninformed concerning this risk, pregnant women may continue to take the drug during pregnancy, potentially causing serious harm to their unborn children. Victims of birth injuries allegedly associated with the use of Topamax are not at fault and may be entitled to reimbursement for their injuries. If you or a loved one has suffered from a cleft lip or hypospadias and you believe Topamax to be the cause, contact a Topamax attorney to discuss the benefits of filing a Topamax lawsuit. The goal of Topamax class action lawsuits is to bring public attention to the potentially dangerous drug, as well as to seek financial compensation for your injuries, treatment expenses, and the pain and suffering sustained by you and your family. Qualified Topamax lawyers are extremely experienced in defective drug litigation and can help alleged Topamax birth defect and topiramate birth injury victims develop an effective case.