Topamax Birth Defects

Millions of Americans suffer from epilepsy and hundreds of thousands of new cases are diagnosed each year. Topamax is one of the many anticonvulsant medications prescribed by physicians to treat the symptoms associated with epilepsy, and was originally approved by the FDA in 1996 for this purpose. Topamax was additionally approved for treatment of migraine headaches in 2004, and has since become one of the most popular forms of anticonvulsant medications on the market. Topamax’s active ingredient, topiramate, is used alone or in combination with other anti-seizure medications in order to prevent migraines and seizures associated with epilepsy. Unfortunately, recent research has indicated a potential connection between Topamax use and the development of major birth defects in infants who are exposed to the drug in utero. Studies have indicated a significantly increased risk of facial malformations, like cleft lip and cleft palate, as well as genital defects in children whose mothers take the topiramate-containing Topamax while pregnant.

Birth Defects Allegedly Associated with Topamax

A birth defect is a malformation of the appearance or function of an infant’s body part, which occurs during fetal development. Most birth injuries are established during the first trimester, or first three months of pregnancy. Some birth defects may affect the outside appearance of a child’s body, making the malformation relatively easy to diagnose. However, some defects, including cardiovascular malformations, occur inside the child’s body and require certain tests in order to diagnose. The severity of birth defects can range from mild to serious, and some may even be fatal.

Cleft Lip

A cleft lip, a possible side effect of Topamax, is a congenital defect affecting the formation of an infant’s lip. During normal fetal development, the lip is formed five to six weeks after conception. However, if there is a lack of tissue in the upper lip preventing the lip from forming correctly, a cleft may occur. A cleft lip is characterized by one or two vertical fissures in the upper lip, which can vary in severity from a mild notch in the upper lip to a crevice which extends up through the nose. Infants born with a cleft lip may struggle with a number of additional complications besides abnormal appearance, including difficulty eating, chronic ear infections, hearing loss, dental problems and delayed language and speech development.

Cleft Palate

Cleft palate Topamax birth defect is similar in nature to a cleft lip, but is characterized instead by a malformation of the infant’s palate. A cleft palate can occur on one or both sides of the mouth and can affect the soft back portion of the mouth or the body front portion of the mouth. The severity of a cleft palate can range from a small opening at the back of the mouth to a large separation of the roof of the mouth. Children suffering from a cleft palate may experience poor growth, failure to gain weight, feeding problems, misaligned teeth, hearing loss, and frequent ear infections.

Genital Malformations – Hypospadias

One of the genital malformations allegedly associated with Topamax use during pregnancy or, one of the possible side effects of topiramate, is hypospadias, a congenital condition in which the opening of the urethra is on the underside of the penis, rather than at the end. Symptoms of hypospadias are abnormal spraying of urine, malformed foreskin which makes the penis look hooded, and having to sit down to urinate. Infants with hypospadias may require several surgeries, the first of which is typically performed before the child is eighteen months old. If this condition remains untreated, the child may have difficulty with toilet training and may experience problems with sexual intercourse later in life.

Topamax and Birth Defects Possible Connection

After several studies regarding the alleged link between Topamax use and major birth injuries were released, the FDA 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. In addition, the FDA released a safety announcement which warned patients and health professionals about the potential connection between the use of Topamax during the first trimester of pregnancy and the development of topiramate birth defects like cleft lip and cleft palate in infants exposed to the drug in utero. The FDA has advised physicians to avoid prescribing Topamax to women of childbearing age unless all other available treatment options have failed.

According to data collected by the North American Antiepileptic Drug Pregnancy Registry, 1.4% of infants exposed to Topamax during pregnancy will develop cleft palate or cleft lip, compared to 0.38-0.55% of infants exposed to other forms of anticonvulsant drugs, and 0.07% of infants whose mothers did not take anticonvulsant drugs during pregnancy. In a small study conducted in 2008 and published in the journal, Neurology, 178 infants born to women taking Topamax were tested for major birth defects. According to the study’s results, four of the 178 infants were born with cleft lip or cleft palate and four male infants were born with genital defects, like hypospadias. According to national averages, the rate of oral malformations in infants whose mothers took Topamax is eleven times higher than normal, and the rate of genital malformations is fourteen times higher. Despite these potential dangers, Topamax remains on the market.

Topamax Use and Pregnancy

Topamax has been labeled by the FDA as a pregnancy category D medication. If you are currently taking Topamax and you are pregnant or planning to become pregnant, consider consulting your physician in order to find an alternative treatment method for your medical condition.

Topamax Birth Defect Lawyers

The birth defects allegedly associated with the use of Topamax have the potential to cause unnecessary physical and emotional complications for an affected child. If you or a loved one has suffered from a birth defect and you believe Topamax to be the cause, contact a qualified Topamax attorney as soon as possible. You may have grounds to file a Topamax class action lawsuit in order to seek financial compensation for your injuries, the expenses resulting from treatment, and the pain and suffering sustained by you and your family. Topamax lawsuits also bring public attention to the importance of safe medications and the need for more stringent restrictions on the potentially dangerous drugs currently on the market. With the help of an experienced Topamax lawyer, victims of alleged Topamax birth defects can develop an effective case and collect the compensation they are entitled to.