Topamax Side Effects

Millions of Americans suffer from epilepsy in the United States, and millions more struggle with debilitating migraine headaches, especially women of childbearing age. In order to treat these conditions, several types of anti-seizure medications have been developed in the past decade or more, and prescribed to consumers with epilepsy and chronic migraines. Topamax is an anticonvulsant medication manufactured by Johnson & Johnson which was approved by the FDA in 1996 to treat epilepsy and was additionally approved to treat migraine headaches in 2004. Topamax’s active ingredient, topiramate, is typically used alone or in combination with other anticonvulsant medications in order to treat migraines, partial onset seizures and primary generalized tonic-clonic seizures in adults and children ten years and older. Topamax functions by reducing the firing of impulses in the brain which are responsible for seizure-related episodes. Unfortunately, recent studies have discovered that infants whose mothers take Topamax while pregnant may have a significantly increased risk of developing certain birth defects than infants whose mothers do not take anticonvulsant drugs during pregnancy.

Topamax Pregnancy and Birth Side Effects

According to recent research, there may be a connection between the use of Topamax during pregnancy and an increased risk of birth injuries in infants who are exposed to the drug in utero. Some of these birth defects include:

  • Cleft lip
  • Cleft palate
  • Genital defects (hypospadias)

Cleft lip and cleft palate are both craniofacial malformations affecting the development of a child’s oral structures, namely the upper lip and the palate, or the roof of the mouth. Hypospadias, on the other hand, is a genital defect affecting males, in which the opening of the urethra is misplaced, resulting in significant complications for an affected child.

Topamax and Birth Defects

A study published in Neurology in 2008 was the first to suggest a possible link between using Topamax while pregnant and the development of adverse side effects, namely birth defects like cleft lip, cleft palate, and genital defects. The study included 203 women who took Topamax while pregnant, either by itself or in combination with another anticonvulsant medication, which is common. Of the 178 live births, four infants were born with cleft palate or cleft lip, a percentage eleven times the rate among normal pregnancies, and four infants developed genital defects like hypospadias, a rate fourteen times the normal average. The researchers also determined that the rate of birth defects was highest among women who took Topamax in combination with valproate, the active ingredient in the anticonvulsant drug, Depakote.

Furthermore, according to data collected by the North American Antiepileptic Drug Pregnancy Registry, approximately 1.4% of infants who are exposed to Topamax in utero may be born with cleft lip or cleft palate, which is significantly higher than the 0.38-0.55% of infants exposed to other anti-epileptic medications, and the 0.07% of infants born to women who do not take anticonvulsant drugs during pregnancy. In response to these findings, the FDA issued a safety announcement to patients and health professionals concerning the possible connection between Topamax use and birth defects like cleft lip and cleft palate. The agency also raised Topamax’s pregnancy category to the second highest classification possible.

Topamax Use and Pregnancy

The FDA has increased the pregnancy category of Topamax from C to D, meaning the drug has the potential to cause significant, unreasonable harm to a human fetus. If you are currently taking Topamax and you are pregnant or planning to become pregnant, consult your physician immediately. It is never advised to terminate use of a prescription medication without medical consent, as this may cause serious adverse reactions. However, with the help of your doctor, you may be able to find a safer alternative to Topamax for treating your epilepsy or migraine headaches.

A Topamax Lawsuit May be Able to Help

The side effects allegedly associated with Topamax use have the potential to cause significant pain and suffering for an affected child. Victims of serious injury potentially linked to 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 Topamax side effect or birth defect, contact a Topamax attorney to discuss the benefits of filing a Topamax lawsuit. The goal of Topamax lawsuits is to seek financial compensation for your injuries, the medical expenses resulting from injury treatment, and the pain and suffering incurred by you and your family. Defective drug lawsuits also bring attention to the importance of safe medications and the need for more strict regulations on the potentially dangerous drugs already on the market. Topamax lawyers are well-versed in defective drug litigation and can help victims of alleged Topamax birth defects develop an effective birth injury case against the drug manufacturing company.