Topiragen and Cleft Lip

Topiragen is a prescription anticonvulsant drug manufactured by pharmaceutical company, Upsher-Smith Laboratories, Inc., which was approved by the FDA as Topamax in 1996. The active ingredient in both Topiragen and Topamax is topiramate, which has been FDA-approved for the treatment of epileptic seizures, as well as the prevention of migraine headaches. Topiragen functions by slowing down certain impulses in the brain which are responsible for seizure-related episodes. Topiragen is specifically indicated for the treatment of both partial onset seizures and tonic-clonic seizures, and, while it cannot treat migraines once they have begun, the drug can prevent migraine headaches from occurring and can also decrease the intensity of migraines. Anticonvulsant medications like Topiragen and Topamax have become increasingly prescribed in recent years, and have become especially popular for the prevention of migraine headaches, which statistics show affect nearly 30 million Americans, particularly women of childbearing age. Unfortunately, recent research has identified a potential link between the use of Topiragen during pregnancy and the development of major birth defects among infants exposed to the drug in utero.

Cleft Lip Signs and Symptoms

Cleft lip is a congenital birth defect in which an affected infant’s upper lip fails to form properly during fetal development. Cleft lip occurs as a result of a lack of tissue in the upper lip area as the cells are fusing together in utero. This defect is characterized by a vertical fissure in the upper lip, which can occur on one or both sides, and can vary in severity from a small opening in the upper lip to a significant opening which may even extend up through the nose.

Cleft Lip Complications and Treatment

Children with a cleft lip often suffer from serious complications which can significantly interfere with the infant’s quality of life. Because a cleft lip creates an opening between the mouth and nose, food and liquid may pass from the mouth back through the nose, causing severe feeding issues. Children with this condition are also prone to having fluid build up in their ears, which can result in frequent ear infections and may even lead to hearing loss. Other complications associated with cleft lip include missing or malformed teeth, and speech and language delay. There are several temporary treatment options for children with cleft lip, including using specially designed baby bottles which keep fluids flowing downward, and inserting tubes in the child’s ears to drain fluid. However, reconstructive surgery is the most effective method of long-term treatment for infants with cleft lip. In severe cases, the affected infant may require several surgical procedures, the first of which is typically performed within the first few months after birth. Following surgery, infants with a cleft lip commonly require long-term dental care and sometimes speech therapy in order to maintain proper speech and language development.

Topiragen and Birth Defects

According to data which was collected by the North American Antiepileptic Drug Pregnancy Registry and was subsequently reviewed by the FDA, infants born to women who take Topamax (topiramate) during the first trimester of pregnancy may be more likely to develop birth defects like cleft lip and cleft palate in utero. According to the registry, the prevalence of these oral defects among infants exposed to Topamax during the first trimester of pregnancy was 1.4%, compared to the prevalence among infants exposed to other anticonvulsants, which was 0.38-0.55%, and among unexposed infants, which was 0.07%. Shortly after this data was collected, the FDA increased Topamax’s drug pregnancy category from C to D, because of the potentially increased risk of oral clefts like cleft lip and cleft palate.

In 2008, the journal Neurology published a study which involved 203 women who became pregnant while taking Topamax. Of the 178 live births reviewed by researchers, sixteen infants were born with major birth defects like cleft palate, cleft lip, and genital defects. Of these sixteen infants, three mothers took Topamax by itself during pregnancy and thirteen mothers took Topamax along with another anticonvulsant while pregnant. The affected infants included four children born with cleft lip or cleft palate and four male children born with a genital defect like hypospadias. The prevalence of cleft lip and cleft palate among infants exposed to Topamax in utero was eleven times what would normally be expected, and the prevalence of genital defects was an alarming fourteen times what is considered normal.

Overall, the rate of birth defects among infants exposed to Topamax in the Neurology study was 4.8%, significantly higher than the rate among the general population, which is approximately one to 2.5%. In addition, researchers determined that the birth defect rate was even higher among infants born to women who took Topamax in combination with valproate, the active ingredient in the anticonvulsant drug Depakote.

Topiragen Use During Pregnancy

Both Topiragen and Topamax have been classified by the FDA as pregnancy category D medications, which means that studies have provided positive evidence of significant human fetal risk associated with the use of these drugs during pregnancy. If you are currently taking Topiragen and you are pregnant or planning to become pregnant, consult your physician immediately. The FDA has advised physicians to avoid prescribing Topiragen or Topamax to pregnant women unless all other available treatment options have failed and the possible benefits of Topiragen or Topamax treatment justify the potential risks to the fetus. It may be dangerous to discontinue use of a prescription medication without medical consent, but with the help of your doctor, you may be able to find a safer alternative to Topiragen or Topamax for treating your medical condition.

A Topiragen Attorney Can Help

Victims of serious injury potentially associated with the use of a defective drug are not at fault and should not be held responsible for their injuries or the medical expenses resulting from caring for their injuries. If you or a loved one has suffered from cleft lip and you believe either the anticonvulsant drug Topiragen or Topamax to be the cause, contact a Topiragen attorney to discuss the benefits of filing a Topiragen lawsuit. The goal of Topiragen lawsuits and potential Topiragen class action lawsuits is to seek financial compensation for your injuries, medical costs, and pain and suffering, as well as to bring public attention to the potentially harmful nature of the drug. Drug manufacturing companies are responsible for the safety of their medications and should be held accountable for adverse side effects sustained by consumers of their products. Unfortunately, some pharmaceutical companies intentionally withhold critical information concerning their drugs in order to avoid a recall or other negative consequences. The only way to protect your rights and stand up to the allegedly deceptive practices of big drug companies is to hire a Topiragen attorney to represent your case.

Defective drug litigation can be a complicated process. Fortunately, Topiragen lawyers are familiar with the history of defective drug cases and have the knowledge and skills necessary to effectively represent your potential Topiragen birth defect case. Following a devastating birth defect diagnosis, victims and their families should be able to focus all their attention and support on making sure the affected individual receives proper medical care, without having to concentrate on filing a Topiragen lawsuit as well. With the help of a qualified Topiragen attorney, potential Topiragen birth defect victims can feel confident that their case is in good hands.