Topiramate Side Effects

Topiramate, a generic form of the drug Topamax, is an anticonvulsant drug which was first discovered in 1979 and 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 is used in the treatment of epileptic seizures in both children and adults and is also frequently prescribed for the prevention of migraine headaches. Topiramate, or generic Topamax, functions by inhibiting the impulses in the brain which are responsible for causing seizure-related episodes. Although topiramate is typically only indicated for seizure and migraine prevention, the drug is also often prescribed for off-label uses such as treatment of bipolar disorder, certain eating disorders, and obsessive-compulsive disorder. Despite the popularity of topiramate in treating both epileptic seizures and migraines, several recent studies have suggested that there may be a link between topiramate use and the development of adverse side effects, namely birth defects like cleft lip, cleft palate, and genital defects, in infants whose mothers take topiramate while pregnant.

Generic Topamax – Topiramate Side Effects

Recent research has indicated a possible connection between the use of topiramate during pregnancy and an increased risk of birth defects in infants exposed to the anticonvulsant drug in utero. Among these topiramate birth defects are craniofacial defects like cleft palate and cleft lip, and genital defects such as hypospadias.

  • Cleft palate is an oral defect involving the improper formation of the palate, or roof of the mouth, during fetal development
  • Cleft lip is an oral defect which affects the formation of the infant’s upper lip in utero
  • Hypospadias is a birth defect affecting the male genitalia in which the opening of the urethra is located on the underside, rather than at the end, of the penis

Both cleft lip and cleft palate have the potential to cause significant physical and developmental complications for an affected infant, including poor growth, feeding difficulties, chronic ear infections, potential hearing loss, missing or misaligned teeth, and speech and language delay. Although these birth defects can typically be corrected with one or more surgeries, the medical costs and potential physical and cognitive disabilities can have a significant burden on the infant and his family.

Topiramate and Birth Defects

Although there have only been a few studies researching the potential link between topiramate use and Topamax side effects like birth injuries, those that have been conducted have portrayed an alarming possibility. The first study was published in the journal Neurology in 2008 and involved 203 women taking topiramate by itself or in combination with another anti-seizure medication, particularly valproate, the active ingredient in the anticonvulsant drug, Depakote. Of the 178 live births, four infants were born with cleft lip or cleft palate, a percentage eleven times what would normally be expected. An additional four male infants were born with genital defects like hypospadias, a rate fourteen times that of the general population. Furthermore, according to researchers, the rate of birth defects increased among women taking topiramate in combination with another anticonvulsant therapy. In fact, the birth defect rate was highest among women who took topiramate and valproate together.

According to a similar study involving seventy-five women with epilepsy who were taking topiramate either as monotherapy or in combination with other anti-epileptic drugs, there may be a cause for concern regarding topiramate use in pregnant women. Of the seventy-five pregnancies, twenty-nine women took topiramate alone and two birth defects resulted. Of the remaining forty-six pregnancies in which the women took topiramate and another anti-seizure medication, seven infants were born with a birth defect. In addition, according to data collected by the North American Antiepileptic Drug Pregnancy Registry, approximately 1.4% of infants who are exposed to generic Topamax during pregnancy may be born with cleft palate or cleft lip, a significant increase from the 0.38-0.55% of infants born to women who took other anticonvulsant drugs, and 0.07% of infants exposed to no anti-epileptic medications during pregnancy.

Topiramate Use and Pregnancy

The FDA has increased the pregnancy category of topiramate, the generic form of Topamax, from C to D, meaning the drug has the potential to cause significant harm to a human fetus. In addition, the FDA has issued a safety announcement warning patients and health professionals about the potential connection between topiramate side effects from use during pregnancy and an increased risk of birth defects in infants exposed to the drug in utero. If you are currently taking topiramate and you are pregnant or planning to become pregnant, consult your physician immediately. It is never advised to discontinue use of topiramate without medical consent, as this may cause even further adverse side effects. But with the help of your doctor, you may be able to find a safer alternative to topiramate for treating your epilepsy or migraine headaches.

A Topiramate Attorney Can Help

Infants who are born with Topamax birth defects like cleft lip, cleft palate, or hypospadias may struggle with additional complications affecting their physical growth and social development, among other aspects of their lives. Victims of adverse side effects potentially related to the use of topiramate are not at fault and should contact a topiramate attorney, as they may be entitled to reimbursement for their injuries. If you or a loved one has suffered from an alleged side effect of topiramate use, contact a topiramate lawyer as soon as possible to discuss your legal options. An experienced topiramate attorney can inform you of your possible courses of action, and will guide you through the process of filing a topiramate lawsuit, should you decide to do so.

The goal of topiramate lawsuits and potential topiramate class action lawsuits is to seek financial reimbursement for your injuries, the expenses associated with injury treatment, and the pain and suffering sustained by you and your family. Defective drug lawsuits also bring substantial attention to the importance of safe medications and the need for more strict regulations on the potentially dangerous drugs already on the market. If you or a loved one has suffered from a potential adverse side effect of topiramate use, the only way to protect your rights is to hire a topiramate attorney and file a topiramate lawsuit against the pharmaceutical company allegedly responsible for your injuries.