Topiramate and Cleft Lip

Topiramate, also known as generic Topamax, is an anticonvulsant drug which was first developed in 1979 and was originally produced by Ortho-McNeil Neurologics and Noramco, Inc., two divisions of Johnson & Johnson. Since the drug’s introduction, topiramate has become one of the most popular forms of anticonvulsant treatment on the market and is widely prescribed to individuals suffering from migraine headaches and epileptic seizures across the United States. Although topiramate is only approved for these treatments, it is often used for off-label purposes as well, including treating bipolar disorder, obsessive-compulsive disorder, and some eating disorders. Topiramate functions by inhibiting the firing of certain impulses in the brain which are responsible for seizure-related episodes.

Topiramate has been prescribed to millions of individuals across the country who are struggling with epilepsy and migraine headaches, particularly women of childbearing age who are more prone to developing debilitating migraines. Unfortunately, recent research has indicated a potential connection between the use of topiramate during pregnancy and the development of birth injuries in infants exposed to the anticonvulsant drug in utero. Among these allegedly associated birth defects and Topamax side effects are genital defects like hypospadias and oral defects like cleft palate and cleft lip.

Cleft Lip Described

During normal fetal development, an infant’s lip is fully formed five to six weeks after conception. However, when there isn’t enough tissue in the lip area as this structure is being formed, the upper lip may fail to fuse completely, resulting in a cleft lip. A cleft lip may be a side effect of topiramate and presents as one or two vertical fissures in the upper lip and can range from a mild notch in the lip to a severe groove which may extend up through the nose.

Complications of Cleft Lip

Children who are born with a cleft lip may struggle with a number of additional complications resulting from the birth defect which can significantly affect the infant’s quality of life. Because there is an opening between the mouth and nose, a child may be unable to eat or drink without food and liquid passing from the mouth back through the nose. Children with cleft lip are also more likely to have fluid build up in their ears, which can cause frequent ear infections and potential hearing loss. In many cases, infants who are born with a cleft lip may also struggle with dental issues like missing or misaligned teeth.

Cleft Lip Treatment

Because of the variety of complications which often accompany a topiramate birth defect like cleft lip, there are a number of treatment options which may benefit the infant. Special baby bottles have been developed which help liquids flow downward, preventing them from passing back through the nose. Children with cleft lip can also have tubes inserted in their ears which may help drain any fluid which has built up. In addition, certain dental and orthodontic procedures can correct the difficulties affected infants may experience with their teeth. Unfortunately, these methods of treatment are merely intended to deal with the side effects caused by a cleft lip; the only way to repair the defect itself is through oral surgery. Depending on the severity of the malformation, a cleft lip may require one or two surgeries, the first of which is typically performed by the time the child is three months old. Fortunately, with surgery and proper care, children with a cleft lip can usually achieve normal appearance, eating habits and speech.

Topiramate and Birth Defects

The FDA recently increased the pregnancy category of topiramate from C to D, which means the drug has the potential to cause significant, unreasonable harm to a human fetus. The agency also released a safety announcement warning patients and health professionals about the potential connection between women taking topiramate during pregnancy and the development of birth defects like cleft lip and cleft palate.

This safety advisory was influenced by a study published in the journal Neurology in 2008 and involved 203 pregnant women who took topiramate by itself or in combination with another anticonvulsant medication during pregnancy. Of the 178 live births, four infants developed cleft lip or cleft palate, a rate eleven times what would be expect among the general population, and four infants were born with genital defects like hypospadias, a rate fourteen times the expected average. In addition, researchers reported that the rate of birth injuries was higher among women who took topiramate in combination with another anti-epileptic drug, particularly valproate, the active ingredient in the anticonvulsant drug, Depakote. In fact, the birth defect rate was highest among women who took topiramate with valproate.

According to the North American Antiepileptic Drug Pregnancy Registry, the rate of birth defects like cleft lip and cleft palate in infants who are not exposed to anticonvulsant drugs in utero is 0.07%, and infants whose mothers take certain anti-epileptic medications during pregnancy have a cleft lip and cleft palate development rate of 0.38-0.55%. In comparison, infants born to women who take topiramate while pregnant are significantly more likely to be born with a cleft lip or cleft palate, with a percentage of 1.4%.

Topiramate and Pregnancy

The FDA has classified the generic form of Topamax as a pregnancy category D, which is the second highest category available, according to FDA safety standards. If you are currently taking topiramate to treat your migraine headaches or epileptic seizures, consult your physician immediately. It is never advised to discontinue use of a prescription medication without medical consent, but with your doctor’s help you may be able to find a safer alternative to topiramate for treating your medical condition.

A Topiramate Attorney Can Help

Craniofacial birth defects like cleft lip can have severe consequences for an affected infant, besides the obvious irregular appearance of the child’s face. Some infants with cleft lip may struggle with feeding difficulties, which can result in low weight and poor growth. Others may experience delays in speech and language development, which can have long-term social complications as well. Some children may even suffer from hearing loss. Victims of serious injury potentially resulting from the use of topiramate are not at fault and should contact a topiramate attorney, as they may be entitled to reimbursement for their injuries. Qualified topiramate lawyers can help victims of alleged topiramate birth defects such as hypospadias receive the reimbursement they are entitled to. The only way to ensure fair compensation for your injuries potentially resulting from topiramate use is to hire a topiramate attorney to represent your case.

If you or a loved one has suffered from cleft lip and you believe the anticonvulsant drug topiramate to be the cause, you may have grounds to file a topiramate 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 compensation for your injuries, the medical expenses associated with injury treatment, and the pain and suffering incurred by you and your family. By filing a topiramate lawsuit, you can also bring public attention to the potentially hazardous nature of topiramate and illustrate the importance of safer medications. Topiramate attorneys are extremely experienced in defective drug litigation and can help victims of alleged topiramate birth defects collect the compensation they deserve.