Topamax Use During Pregnancy

Topamax is a prescription anticonvulsant medication manufactured by Johnson & Johnson and approved to treat both migraine headaches and the seizures associated with epilepsy. The active ingredient in Topamax, called topiramate, functions by slowing down the impulses in the brain which are responsible for causing seizure-related episodes. Topamax was originally approved by the FDA in 1996 but the agency didn’t approve the migraine indication until 2004. Because nearly 2.3 million Americans suffer from epilepsy and an additional 30 million Americans experience chronic migraine headaches, Topamax may seem like an appropriate treatment method. However, recent studies have indicated a potential connection between Topamax use during pregnancy and an increased risk of birth defects in infants.

Alleged Topamax Birth Defects

Topamax has been linked to two different craniofacial defects, cleft lip and cleft palate, as well as a genital defect in males, known as hypospadias. Cleft lip occurs when there is a lack of tissue in the lip area during the first five to six weeks of development in utero, resulting in a split in the upper lip which may extend up through the nose. Cleft palate is similar to cleft lip, but this condition affects the infant’s palate, or the roof of the mouth. When there isn’t enough tissue the allow the palate to fully close during early fetal development, a cleft palate may occur, sometimes resulting in a nearly complete separation of the roof of the mouth. Finally, hypospadias is a congenital defect in which the opening of the urethra is located on the underside of the penis rather than at the end.

Topamax and Birth Defects Potential Connection

There have been two major sources of information concerning Topamax and pregnancy which have indicated a potential for Topamax birth defects in infants who are exposed to the anticonvulsant medication in utero. According to data collected by the North American Antiepileptic Drug Pregnancy Registry, 1.4% of infants whose mothers take Topamax while pregnant may develop cleft lip or cleft palate, a considerable increase compared to 0.38-0.55% of infants born to women who take other anti-seizure medications, and 0.07% of infants born to women who take no anti-epileptic drugs at all.

Furthermore, according to a 2008 study published in Neurology, of the 178 infants whose mothers took Topamax alone or with another anticonvulsant drug during pregnancy, four developed cleft lip or cleft palate, a percentage eleven times the normal average. In addition, four infants were born with genital defects like hypospadias, a rate fourteen times the normal average. Even more revealing was the finding that there were more birth defects among women who took topiramate in combination with valproate, the active ingredient in the anticonvulsant drug Depakote. In fact, the study showed that the birth defect rate was highest among women who took Topamax and valproate together.

Topamax Use While Pregnant

The FDA increased the pregnancy category of Topamax from C to D, the second highest pregnancy category, which means the drug has the potential to cause significant, unreasonable harm to a human fetus. The FDA also released a recent safety announcement regarding the alleged connection between Topamax and certain craniofacial birth defects 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 to discuss your treatment options. You should never stop taking a prescription medication without medical consent, but with your doctor’s help you may be able to find a safer alternative to Topamax for treating your medical condition.

A Topamax Lawyer Can Help

The birth defects potentially associated with the use of Topamax during pregnancy can cause substantial complications for an affected child. If you or a loved one has suffered from a birth defect like cleft lip, cleft palate or hypospadias, and you believe Topamax to be the cause, contact a Topamax attorney as soon as possible. A qualified Topamax lawyer will ensure that you are aware of your legal options and can also inform you of the benefits of filing a Topamax lawsuit against the drug manufacturing company. The goal of Topamax lawsuits or Topamax class action lawsuits is to seek financial compensation 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 much-needed attention to the importance of safe medications and the need for more strict regulations regarding the potentially dangerous drugs already on the market. With the help of an experienced Topamax attorney, victims of alleged Topamax birth injuries can develop an effective Topamax lawsuit birth defect claim and collect the compensation they are entitled to.