Topamax Hypospadias Genital Defects

Topamax is an anticonvulsant medication which is currently manufactured by Johnson & Johnson and was approved by the FDA in 1996 to treat epileptic seizures and in 2004 to treat migraine headaches. The active ingredient in Topamax is topiramate, which functions by reducing the firing of impulses in the brain which are responsible for seizure-related episodes. Although Topamax has only been approved to prevent migraines and epileptic seizures, the drug is also often used for off-label purposes such as bipolar disorder treatment. Since the drug’s introduction, Topamax has become one of the most popular forms of anticonvulsant treatment on the market. However, in recent years several studies have been conducted which indicate a possible connection between Topamax use and the development of birth defects in infants who are exposed to the drug in utero. Among these Topamax side effects and birth defects is a type of genital defect which affects males, called hypospadias.


Hypospadias is a congenital birth defect affecting the male genitals in which the opening of the urethra is on the underside of the penis, rather than at the end. Instances of hypospadias can vary in severity; in some cases the opening is located near the tip of the penis, on the underside. In more severe cases, the opening may be at the midshaft or the base of the penis, and occasionally, the opening may be located in or behind the scrotum.

Hypospadias Gential Defects Treatment and Complications

Males who suffer from hypospadias genital birth defects may struggle with complications including abnormal spraying of urine, malformed foreskin which makes the penis look hooded, and having to sit down to urinate. Infants with this condition typically receive surgery before they are eighteen months old and the procedure may even be performed at four months old. During surgery, the penis is straightened and the defect is corrected using tissue grafts from the infant’s foreskin. If left untreated, hypospadias may cause a child to have difficulty with toilet training as well as problems with sexual intercourse later in life.

Studies Allegedly Linking Topamax to Gential Birth Defects and Hypospadias

The first study to suggest a potential connection between Topamax and birth defects was published in Neurology in 2008 and involved 178 infants born to women taking Topamax while pregnant. These women took Topamax either alone or in combination with another anticonvulsant medication. According to the study, of the 178 births, four infants were born with genital defects like hypospadias, a rate fourteen times what is expected among women who do not take anti-epileptic medications, and four additional infants developed Topamax birth defects like cleft lip or cleft palate, a percentage eleven times the national average. Furthermore, researchers determined that there were more birth injuries among women who took topiramate in combination with valproate, the active ingredient in the anti-seizure medication Depakote. In fact, the rate of birth defects was highest among women who took Topamax and valproate together. In support of these findings, data collected by the North American Antiepileptic Drug Pregnancy Registry suggests that 1.4% of infants exposed to Topamax during pregnancy may develop cleft lip or cleft palate, compared to 0.38-0.55% of infants exposed to other anticonvulsant drugs, and 0.07% of infants not exposed to any anti-epileptic medications.

Topamax Use and Pregnancy

When these findings were released, the FDA issued a safety announcement warning patients and health professionals about the potential connection between Topamax use and an increased risk of topiramate birth defects like cleft lip and cleft palate. The FDA also increased the pregnancy category of Topamax from C to D, which means 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 to discuss your treatment options.

Consult a Topamax Lawsuit Attorney

Birth injuries like hypospadias may cause significant physical and emotional pain as well as costly medical expenses for an affected child and his family. Victims of serious injury potentially resulting from the use of Topamax are not at fault and may be entitled to financial compensation for their injuries, the medical expenses associated with injury treatment, and the pain and suffering sustain by victims and their families. If you or a loved one has suffered from a genital defect like hypospadias, and you believe Topamax to be the cause, contact a Topamax attorney to discuss the benefits of filing a Topamax lawsuit. Defective drug class action Topamax lawsuits bring public attention to the importance of safe medications as well as the need for more stringent regulations on the potentially dangerous drugs already on the market. Experienced Topamax lawyers are extremely qualified in defective drug litigation and can help victims of alleged Topamax birth defects collect the compensation they deserve.