Topamax and Cleft Palate

According to national statistics, approximately 2.3 million Americans suffer from epilepsy, and nearly 30 million Americans struggle with migraine headaches. One of the most popular forms of treatment for these conditions is Topamax, an anticonvulsant medication manufactured by Johnson & Johnson. Topamax was originally approved by the FDA to treat epileptic seizures in 1996 and was additionally approved to treat migraines in 2004. Although Topamax has only been FDA approved to treat these disorders, it is also often used for off-label purposes like treating bipolar disorder. Unfortunately, recent research has indicated a potential connection between the use of Topamax during pregnancy and the development of birth defects like cleft palate in infants exposed to Topamax during pregnancy. Because epilepsy is so common, and because women are three times more likely to suffer from debilitating migraines than men, especially women of childbearing age, the possibility of Topamax-related birth defects may pose a serious risk for consumers who take this medication.

Cleft Palate Birth Defects Described

Cleft palate is a possible Topamax side effect which is known as a craniofacial malformation and affects the formation of the child’s palate, or roof of the mouth. A cleft palate occurs when there isn’t enough tissue in the mouth during fetal development, preventing the palate from fusing correctly and resulting in an opening on one or both sides of the mouth. The severity of a cleft palate can vary from a small opening at the back of the mouth to a severe separation of the roof of the mouth, and can involve the bony front portion of the mouth or the soft back portion of the mouth.

Cleft Palate Treatment and Complications

Because many children with cleft palate and other topiramate side effects may struggle with feeding difficulties, there are special bottles which prevent the liquid from flowing back through the mouth and into the nose. A child with cleft palate may also benefit from utilizing an artificial palate in order to allow him to eat properly until surgery can be performed. Children with cleft palate are more prone to having fluid build up in their ears, which can result in chronic ear infections and hearing loss. In order to prevent these complications, tubes may be inserted in the child’s ears to help drain the fluid properly. Finally, many children with this defect struggle with dental issues including missing or malformed teeth, which can usually be corrected with oral surgery. In many cases of cleft palate, the affected child will require several surgeries to repair the malformation, the first of which is typically performed within six months of birth.

Topamax and Cleft Palate Alleged Link

According to recent studies, women who take Topamax while pregnant may increase their risk of giving birth to children with one or more birth injuries, including cleft lip, cleft palate and genital defects. One study published in 2008 in Neurology reviewed 178 births involving women who took Topamax either alone or with another anti-seizure medication while pregnant. The results of this study showed that the incidence of birth defects among infants exposed to topiramate-containing Topamax was higher than the expected rate of birth defects among the general population. Four of the 178 infants included in this study were born with cleft lip or cleft palate, a rate eleven times higher than average, and four infants were born with a genital defect like hypospadias, a rate fourteen times higher than average. In addition, researchers determined that there were more birth defects among women taking topiramate in combination with valproate, the active ingredient in the anticonvulsant drug Depakote. In fact, according to the study, the birth defect rate was highest among women who took Topamax and valproate together.

Data collected by the North American Antiepileptic Drug Pregnancy Registry suggests that 1.4% of children whose mothers take Topamax during pregnancy may develop cleft lip or cleft palate, compared to 0.38-0.55% of infants exposed to other anti-seizure medications, and 0.07% of children born to women who took no anticonvulsant drugs during pregnancy. Once these studies were released, the FDA issued a safety announcement concerning the potential connection between Topamax and birth defects like cleft palate and cleft lip. 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.

Topamax and Pregnancy

If you are currently taking Topamax and you are pregnant or planning to become pregnant, consult your physician as soon as possible. You should never stop taking your prescription medication without your doctor’s consent, but with his help, you may be able to find a safer alternative to Topamax for treating your epilepsy.

A Topamax Lawyer Can Help

If you or a loved one has suffered from a cleft palate or a genital defect and you believe Topamax to be the cause, contact a Topamax attorney to discuss the benefits of filing a Topamax lawsuit. The goal of Topamax lawsuits is to seek financial compensation for your injuries, the expenses associated with injury treatment, and the pain and suffering incurred by you and your family. Topamax defective drug class action lawsuits also bring public attention to the importance of safe medications and the need for more strict regulations on the potentially dangerous drugs already on the market. With the guidance of a knowledgeable Topamax lawyer, victims of alleged Topamax birth defects can collect the compensation they deserve. Topamax attorneys are extremely qualified in defective drug litigation and can help victims develop effective birth injury cases against drug manufacturing companies.