Topiramate is a generic form or active ingredient of the anti-epileptic drug, Topamax, which is currently manufactured by Johnson & Johnson. Topiramate is an anticonvulsant treatment indicated for the prevention of epileptic seizures in both adults and children, as well as the prevention of chronic migraine headaches. Topiramate has also been used to treat Lennox-Gastaut syndrome in children, a disorder which causes seizures and developmental delay. Although its only approved uses are as a seizure and migraine treatment, topiramate has also been used for off-label purposes like treating bipolar disorder, alcoholism, obsessive-compulsive disorder and obesity. Topiramate has also been used in clinical trials to treat post-traumatic stress disorder and several studies indicate additional uses for the drug, for which it has not yet been approved. Topiramate was first developed as an anti-epileptic treatment in 1979 and was originally produced by Ortho-McNeil Neurologics and Noramco, Inc., two divisions of Johnson & Johnson.

Topiramate and Birth Defects

Despite the popularity of topiramate in treating migraine headaches and epileptic seizures, recent studies have indicated a potential link between the anticonvulsant drug and an increased risk of birth defects and Topamax side effects in infants exposed to the drug in utero. The most common of these birth defects are:

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

Cleft Palate

Cleft palate is a craniofacial defect which is a potential Topamax birth defect affecting the formation of the child’s palate, or roof of the mouth. When there isn’t enough tissue for the palate for form correctly during early fetal development, a cleft may occur. A cleft palate can affect either side of the mouth and can involve the soft back portion of the mouth or the bony front portion of the mouth. In minor cases, a cleft may create a small hole at the back of the mouth, and in more severe instances, a cleft palate may cause a nearly complete separation of the roof of the mouth. Children with cleft palate often suffer from feeding difficulties, frequent ear infections, hearing loss, failure to gain weight, poor growth, and dental issues like missing or malformed teeth.

Cleft Lip

Cleft lip is similar in nature to a cleft palate, but affects the infant’s lip instead. During normal fetal development, the lip is fully formed five or six weeks after conception. However, when there isn’t enough tissue in the lip area for the lip to fully form, a cleft may occur. A cleft lip from topiramate is characterized by one or two vertical fissures in the upper lip, which can vary in severity from a mild notch to a large crevice which may extend up through the nose. Infants born with a cleft lip may experience chronic ear infections, hearing loss, dental problems and eating issues.

Hypospadias – Gential Birth Defects

Hypospadias is a congenital malformation affecting male children in which the opening of the urethra is located on the underside, rather than at the end, of the penis. In more severe instances of this condition, the opening may be located at the midshaft or the base of the penis, or in or behind the scrotum. Children who are born with hypospadias from Topamax may struggle with a series of complications, including malformed foreskin, abnormal spraying of urine, and having to sit down to urinate. In addition, infants with this condition may experience difficulties in toilet training as well as during sexual intercourse later in life.

Dangers of Topiramate Use and Pregnancy

The FDA has released a safety announcement regarding the potential connection between topiramate use and birth defects, and has also increased topiramate’s pregnancy category from C to D, which means the drug has the potential to cause significant harm to a human fetus. Women who take the anticonvulsant drug, topiramate, or the brand name equivalent Topamax during pregnancy may have an increased risk of giving birth to a child with one or more birth defects. Furthermore, according to research, the use of topiramate in combination with other anti-epileptic medications, such as valproate, may significantly increase this risk. If you are currently taking topiramate and you are pregnant or planning to become pregnant, consult your physician immediately in order to discuss alternative treatment options.

Topiramate and Birth Defects Potential Link

The first study to reveal the potential link between topiramate side effects and birth injuries like cleft palate, cleft lip and hypospadias, was published in the journal Neurology in 2008. The study investigated the births of 178 infants born to women who took topiramate, alone or in combination with another anticonvulsant drug, while pregnant. According to the results, four of the 178 infants developed facial defects like cleft lip and cleft palate, which is eleven times higher than what would be expected among infants not exposed to anticonvulsants in utero. In addition, four infants were born with genital defects like hypospadias, which represents a percentage fourteen times higher than average. Even more revealing, researchers found that the rate of birth defects was the highest among women who took topiramate in combination with valproate, the active ingredient in the anti-seizure medication Depakote. In support of these findings, data collected by the North American Antiepileptic Drug Pregnancy Registry has determined that 1.4% of infants who are exposed to topiramate during pregnancy may develop cleft palate or cleft lip, compared to 0.38-0.55% of infants who are exposed to other anticonvulsants in utero, and 0.07% of infants not exposed to any anti-seizure medications at all.

A Topiramate Lawsuit Attorney Can Help

The birth defects allegedly associated with the use of topiramate may cause a number of physical and emotional difficulties for an affected child. Victims of serious injury potentially resulting from the use of topiramate are not at fault and may be entitled to reimbursement for their injuries. If you or a loved one has suffered from cleft palate, cleft lip or a genital defect like hypospadias, and you believe topiramate to be the cause, contact a topiramate attorney to discuss the benefits of filing a topiramate lawsuit. The goal of topiramate lawsuits is to seek financial compensation for your injuries, the expenses resulting from injury treatment, and the pain and suffering sustained by you and your family. With the help of an experienced topiramate lawyer, victims of alleged topiramate birth defects can be confident that their potential birth injury case is in good hands.