Topiramate Birth Defects

Topiramate, or generic Topamax, is an anticonvulsant drug commonly used in the treatment of both epilepsy and migraine headaches. The effectiveness of topiramate as an anticonvulsant was first discovered in 1979 and the drug was originally produced by Ortho-McNeil Neurologics and Noramco, Inc., two divisions of Johnson & Johnson. Since then, topiramate has become one of the most widely-prescribed forms of anti-seizure medication on the market. Topiramate functions by inhibiting the firing of certain impulses in the brain which are responsible for seizure-related episodes. Although topiramate has only been approved for the prevention of migraines and epileptic seizures, the medication is also often used for off-label purposes like the treatment of obsessive-compulsive disorder, bipolar disorder, and certain eating disorders.

Topiramate has been prescribed to millions of individuals suffering from these conditions, particularly women of childbearing age for whom migraine headaches are most common. Unfortunately, recent research has identified a possible link between topiramate side effects from use during pregnancy and a number of birth defects in infants exposed to the drug in utero. Sadly, because nearly half of all pregnancies are unplanned, women of childbearing age taking topiramate may cause considerable harm to their unborn child before they are even aware they are pregnant.

Topiramate and Cleft Palate

A cleft palate is a craniofacial birth defect characterized by the malformation of the child’s palate, or roof of the mouth, during fetal development. A cleft palate typically occurs when there isn’t enough tissue in the mouth when the palate is developing, resulting in an opening in the roof of the mouth. This defect can affect one or both sides of the mouth and may involve the soft back portion of the mouth or the bony front portion of the mouth. The severity of a cleft palate can vary from a small opening at the back of the mouth to an almost complete separation of the palate. Infants with cleft palate may suffer from significant complications like feeding difficulties, poor growth, frequent ear infections, hearing loss, speech delay, and dental problems like missing or malformed teeth.

Topiramate and Cleft Lip

During normal fetal development, the lips are fully formed five to six weeks after conception. However, if there isn’t enough tissue in the lip area, the lip may fail to fuse completely and a cleft may occur. A cleft lip is characterized by one or two vertical fissures in the upper lip which can range from a mild slit in the lip to a large crevice which may extend up through the nose. Infants with cleft lip may struggle with eating problems, dental issues like missing or misaligned teeth, chronic ear infections, and potential hearing loss.

Topiramate and Hypospadias

Hypospadias is a birth defect affecting the formation of the male genitalia during fetal development. In infants with hypospadias, the opening of the urethra is located on the underside of the penis, rather than at the end. The severity of this condition can range from the opening being near the tip of the penis, to being at the midshaft or base of the penis, to being located in or behind the scrotum. Children with hypospadias may struggle with abnormal spraying during urination, forcing them to sit down to urinate. If left untreated, further complications may result in difficulty toilet training and problems with sexual intercourse in adulthood.

Topiramate and Birth Defects

According to recent research, there may be a connection between the use of topiramate by pregnant women and the development of birth defects in infants exposed to the drug in utero. The first study to discover this potential link was published in Neurology in 2008 and involved 203 pregnant women taking topiramate either by itself or in combination with another anti-epileptic drug like valproate, the active ingredient in the anticonvulsant drug, Depakote. Of the 178 live births, four infants were born with genital defects like hypospadias, a rate fourteen times higher than would be expected in the general population. In addition, four infants developed cleft lip or cleft palate, a percentage eleven times the national average. Furthermore, researchers indicated that the rate of topiramate birth defects was higher among women who took topiramate with another anti-seizure medication, and was highest when topiramate and valproate were taken together.

In support of these findings, data collected by the North American Antiepileptic Drug Pregnancy Registry has indicated that 1.4% of infants exposed to topiramate during pregnancy may develop cleft lip or cleft palate. This percentage is significantly higher than the 0.38-0.55% of infants born to women taking a different anticonvulsant medication and the 0.07% of infants born to women who took no anticonvulsants while pregnant. Following the release of these findings, the FDA issued a safety announcement warning health professionals and patients about the potential connection between topiramate use during pregnancy and the development of craniofacial birth defects like cleft lip and cleft palate. In addition, the FDA increased the pregnancy category of the generic form of Topamax from C to D, meaning the drug has the potential to cause serious harm to a human fetus.

Topiramate Use and Pregnancy

If you are currently using topiramate to treat your epilepsy or migraine headaches and you are pregnant or planning to become pregnant, contact your physician as soon as possible. Despite the potential dangers associated with topiramate use, it is never advised to discontinue use of a prescription medication without medical consent, as this may cause further adverse side effects. Instead, discuss your treatment options with your doctor and together, you may be able to find a safer alternative to topiramate for treating your medical condition.

A Topiramate Attorney Can Help With Lawsuits

If you or a loved one has suffered from a birth defect like hypospadias, cleft palate or cleft lip, and you believe the generic form of Topamax, topiramate, to be the cause, you may have grounds to file a topiramate lawsuit against the pharmaceutical company allegedly responsible for your injuries. The goal of potential topiramate lawsuits and topiramate class action lawsuits is to seek financial compensation for your injuries, the medical expenses resulting from 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 stringent regulations on the potentially dangerous drugs already on the market.

Victims of alleged topiramate birth defects are not at fault for any injuries sustained while using the potentially defective drug, and should contact a topiramate attorney for legal guidance. Topiramate lawyers are well-versed in defective drug litigation and can effectively and professionally educate birth defect victims of their legal options. An experienced topiramate attorney will strive to help you collect the compensation you deserve, should you choose to file a topiramate lawsuit. With the help of a qualified topiramate lawyer, potential victims of topiramate birth defects can feel confident that their case is in good hands.