Topiramate and Cleft Palate

Topiramate, is a generic version of the anticonvulsant drug Topamax, which is currently manufactured by the pharmaceutical company Johnson & Johnson. Topiramate has proven effective in treating chronic migraine headaches, as well as epileptic seizures in adults and children ages ten and older. The anti-epileptic nature of topiramate was first discovered in 1979 and the drug was originally produced by Ortho-McNeil Neurologics and Noramco, Inc., two divisions of Johnson & Johnson. Since its introduction, topiramate has become one of the most popular forms of anticonvulsant treatment on the market. Topiramate, or generic Topamax, functions by slowing down impulses in the brain which are responsible for seizure-related episodes. Although topiramate has only been approved for migraine and epilepsy treatment, the drug is often used for off-label purposes like treatment for obsessive-compulsive disorder, bipolar disorder, and certain eating disorders.

Unfortunately, despite the drug’s popularity, topiramate has been the subject of significant scrutiny in recent years because of a potential connection between topiramate use during pregnancy and the development of birth defects in infants who are exposed to the anticonvulsant drug in utero. Among these birth injuries and topiramate side effects is a craniofacial birth defect called cleft palate. Others include an oral defect called cleft lip and genital defects like hypospadias.

Cleft Palate

During normal fetal development, a child’s palate is formed at approximately thirty-five days gestation. However, when there is a problem during the formation of this oral structure, resulting in a lack of tissue in the roof of the mouth, a cleft palate may occur. A Topamax cleft palate can affect one or both sides of the mouth and may involve the bony front portion of the mouth or the soft back portion of the mouth. The degree of the defect can range from a small opening at the back of the mouth to a nearly complete separation of the roof of the mouth, and can cause several difficulties for an affected child.

Complications of Cleft Palate

There are a number of complications which may affect a child born with a cleft palate. Because there is an opening in the palate, food and liquid may pass from the mouth back through the nose, resulting in severe feeding difficulties. Infants with a cleft palate are also more prone to fluid building up in their ears, which can result in chronic ear infections and potential hearing loss. Many children with cleft palate or cleft lip from topiramate also struggle with speech and language delay due to problems properly forming words, and dental problems like excessive cavities, and missing or malformed teeth.

Treatment of Cleft Palate

There are several methods of treatment intended to relieve the side effects associated with cleft palate, including:

  • Bottles designed to keep fluid flowing downward
  • Man-made palates to help children eat properly
  • Tubes inserted in the ears to drain fluid build-up
  • Frequent dental and orthodontic checkups

Although these options may effectively treat the complications associated with cleft palate, the only way to correct the defect itself is through oral surgery. In order to repair the malformation, children often require multiple surgeries, the first of which is typically performed before the child is six months old. By the time the child is eight, he may require a bone graft to fill in the upper gum line so that it can support permanent teeth. The child may also receive additional surgeries throughout childhood and adulthood in order to improve the function and appearance of the child’s jaw.

Topiramate and Birth Defects

Although there have only been a few studies to deal with the potential connection between topiramate and birth defects, the results of these studies have proven significant. One of the first of its kind was a study published in the journal Neurology in 2008 which involved 203 pregnant women who took topiramate during pregnancy, either by itself or in combination with another anticonvulsant drug like valproate, the active ingredient in Depakote. Of the 178 live births, four infants developed cleft lip or cleft palate, a rate eleven times what would be expected among the general population, and four infants developed genital defects like hypospadias, a percentage fourteen times the average. Even more telling was the finding that the rate of birth defects increased when topiramate was taken with another anticonvulsant medication, and the rate was highest among women who took topiramate and valproate together. Along the same vein, another small study tested topiramate exposure in seventy-five women taking topiramate either as monotherapy or in combination with another anti-epileptic drug. Researchers found that, of the twenty-nine monotherapy exposures, two infants developed birth defects, and of the remaining forty-six infants exposed to multiple anticonvulsant medications, seven were born with a birth defect.

In further support of the potential link between topiramate use and Topamax birth defects, data collected by the North American Antiepileptic Drug Pregnancy Registry has suggested that 1.4% of infants exposed to generic Topamax during pregnancy may be born with cleft lip or cleft palate. While this percentage may seem low, it represents a significant increase from the 0.38-0.55% of affected infants born to women exposed to a different anticonvulsant medication, and the 0.07% of affected infants exposed to no anti-epileptic medications during pregnancy. Upon review of these findings, the FDA issued a safety announcement warning patients and health care professionals about the alleged link between topiramate use during pregnancy and the development of birth defects in infants. In addition, the FDA increased the pregnancy category of topiramate from C to D, which means the drug has the potential to cause serious harm to a human fetus.

Topiramate Use and Pregnancy

Topiramate has been labeled a pregnancy category D by the FDA, the second highest FDA pregnancy category available. If you are currently taking topiramate and you are pregnant or planning to become pregnant, consult your physician immediately. You should never stop taking a prescription medication without medical consent, but your doctor may be able to inform you of alternative treatment options for controlling your migraine headaches or epileptic seizures without the potentially hazardous Topamax side effects.

Contact a Topiramate Attorney for Help

If you or a loved one has suffered from cleft palate and you believe the anticonvulsant drug topiramate to be the cause, you may have grounds to file a topiramate lawsuit or topiramate class action lawsuit against the pharmaceutical company allegedly responsible for your injuries. The goal of topiramate lawsuits and potential topiramate class action lawsuits is to seek financial reimbursement for your injuries, the medical expenses associated with treating and caring for the injury, and the pain and suffering incurred by you and your family. Defective drug lawsuits are also important because they alert the public of the potential dangers of certain drugs and illustrate the need for safer medications on the market.

Victims of serious injury allegedly resulting from the use of topiramate are not at fault and should contact a topiramate attorney to discuss their legal options. Drug manufacturing companies are responsible for the safety of their medications and should be held accountable for the adverse side effects sustained by consumers of their products. Unfortunately, this isn’t always the case. Following the diagnosis of a birth defect, the families of potential topiramate birth injury victims should be permitted to focus their support and attention on the victim without having to worry about collecting evidence to develop a topiramate case. Topiramate lawyers are experienced in defective drug litigation and have the knowledge and skill necessary to effectively represent a topiramate birth defect case. The only way to protect your rights as a injury victim and collect the compensation you deserve is to hire a topiramate attorney to represent your alleged topiramate birth defect case.