Topiragen and Cleft Palate

Anticonvulsant medications have become increasingly prescribed in recent years for individuals suffering from epilepsy and other medical disorders, such as persistent migraine headaches. According to the U.S. Centers for Disease Control and Prevention, approximately 2.3 million people suffer from epilepsy in the United States, with 200,000 new cases diagnosed each year. In addition, nearly 30 million Americans struggle with migraine headaches, a condition which affects women of childbearing age far more often then other women and men. In order to treat these debilitating conditions, physicians have embraced anticonvulsant drugs like Topiragen and prescribed them to affected individuals across the United States. Topiragen was approved as Topamax (topiramate) by the FDA in 1996 and is currently manufactured by pharmaceutical company, Upsher-Smith Laboratories.

Topiragen has been FDA-approved for the treatment of epileptic seizures, particularly tonic-clonic seizures and partial onset seizures, and the prevention of migraine headaches. Although Topiragen typically doesn’t treat migraines once they occur, it can prevent migraines from occurring and can also decrease the intensity of migraine headaches. Topiragen functions by inhibiting the impulses in the brain which are responsible for causing seizure-related episodes. Topiragen has become one of the most popular anticonvulsant medications available in recent years. In fact, according to the FDA, approximately 32.3 million individuals filled prescriptions for Topamax, Topiragen, or a generic form of the medications between January 2007 and December 2010. Unfortunately, several studies in recent years have indicated that women who take topiramate-containing Topamax or Topiragen while pregnant may increase their risk of giving birth to infants with genital birth defects like hypospadias, and craniofacial birth defects like cleft lip and cleft palate.

Cleft Palate Signs and Symptoms

Under normal circumstances, the formation of a child’s palate begins near the end of the fifth week of gestation. However, when there isn’t enough tissue in the roof of the mouth during fetal development, the palate may fail to fuse completely and a congenital birth defect called cleft palate may occur. A cleft palate can occur on one or both sides of the mouth and can involve the soft back portion of the mouth or the bony front portion of the mouth. The degree of damage to the palate can vary from a small opening at the back of the throat to a nearly complete separation of the roof of the mouth.

Cleft Palate Treatment and Complications

Children suffering from a cleft palate may struggle from significant complications resulting from the birth defect. The only way to permanently repair these defects is to perform reconstructive surgery. Many children with cleft palate will require several surgeries, the first of which is performed within six months of birth. Fortunately, there are several temporary treatment options which can relieve the symptoms associated with cleft palate before surgery can be conducted. Following the surgeries, children with cleft palate may require long-term dental and orthodontic care in order to prevent further complications.

Because of the opening in the roof of the mouth, some children with this condition may suffer from feeding difficulties in which food or liquid passes from the mouth back through the nasal passage. In order to prevent this from happening, some people may use a special baby bottle which is designed to keep fluids flowing downward. Some children with a cleft palate may also benefit from having an artificial palate implanted in their mouth in order to help them eat properly until surgery can be performed. Many children with cleft palate are also prone to having fluid build up in their ears, which can lead to chronic ear infections and even hearing loss. This can be treated by inserted tubes in the child’s ears in order to drain the fluid properly. Many children with cleft palate also struggle with dental issues like missing or malformed teeth, as well as speech and language delay, all of which can be corrected with oral surgery.

Topiragen and Birth Defects

In 2008, the journal Neurology published a study which involved 203 women who took Topamax during pregnancy. Of the 178 live births reviewed, sixteen infants were born with major birth defects like cleft lip, cleft palate, and genital defects like hypospadias. Overall, the birth defect rate was 4.8% compared to the rate of birth defects among the general population, which is one to 2.5%. Of the sixteen affected children, three of the mothers took Topamax by itself and thirteen mothers took Topamax in combination with another anticonvulsant drug while pregnant. Among the infants born with birth defects, four had cleft lip or cleft palate, a rate eleven times what would be expected among the general population, and four male infants were born with genital defects like hypospadias, a rate fourteen times what is considered normal. Researchers also determined that the birth defect rate was even higher among infants whose mothers took Topamax in combination with valproate, the active ingredient in the anticonvulsant drug, Depakote.

According to data collected by the North American Antiepileptic Drug Pregnancy Registry and reviewed by the FDA, the frequency of craniofacial birth defects like cleft lip and cleft palate among infants may be associated with the use of Topamax, or topiramate, during the first trimester of pregnancy. The data indicates that the prevalence of cleft lip and cleft palate among infants exposed to Topamax in utero was 1.4%, compared to the prevalence among infants exposed to other anticonvulsant drugs, which was 0.38-0.55%, and among infants exposed to no anticonvulsant drugs in utero, which was 0.07%. It was after this data was released that the FDA classified Topamax (topiramate) as a pregnancy category D medication.

Topiragen Use and Pregnancy

The anticonvulsant drug Topiragen contains the same active ingredient as Topamax (topiramate), for which the FDA has increased the pregnancy category from C to D. This means there is positive evidence of the drug’s capability to cause significant, unreasonable harm to a human fetus. The FDA has advised physicians to avoid prescribing Topamax or topiramate-containing Topiragen to pregnant women unless the possible benefits of the drug justify the potential risks to the fetus. If you are currently taking Topiragen and you are pregnant or planning to become pregnant, consult your physician immediately. You should never stop taking a prescription medication without medical consent, but with the help of your doctor you may be able to find a safer alternative to Topiragen for treating your medical condition.

A Topiragen Attorney Can Help

If you or a loved one has suffered from a major birth defect which you believe to be associated with the use of Topiragen, contact a Topiragen attorney to discuss your legal options. You may have grounds to file a Topiragen lawsuit against Upsher-Smith Laboratories in order to seek financial compensation for your injuries and your medical expenses, as well as the pain and suffering endured by you and your family. Victims of serious injuries potentially resulting from the use of an allegedly dangerous drug are not at fault. Drug manufacturing companies are responsible for the safety and effectiveness of their medications and should be held accountable for an unreasonable adverse side effects sustained by consumers of their products. Unfortunately, some pharmaceutical companies intentionally withhold dangerous drug information in order to protect the interests of the manufacturing company. The only way to protect your rights and stand up to big drug companies is to hire a qualified Topiragen lawyer to represent your case.

Besides seeking compensation for your injuries, medical costs and pain and suffering, potential Topiragen lawsuits and Topiragen class action lawsuits also bring public attention to the importance of safe medications and the need for more strict regulations on the potentially harmful drugs already on the market. Defective drug litigation can be a complicated process, but with the help of an experienced Topiragen attorney, victims of potential Topiragen birth defects can have the peace of mind that their case is being effectively represented by a professional.