Millions of Americans suffer from epilepsy, a neurological disorder which causes seizures and interferes with a variety of physical and mental functions. According to the Epilepsy Foundation, a seizure is characterized by a brief, strong surge of electrical activity, which causes disturbances involving part or all of the brain. In order to treat epilepsy, many individuals are prescribed anticonvulsant medications like Topamax or Topiragen, two anti-epileptic drugs which contain the active ingredient, topiramate. Topiramate is also sometimes used for off-label purposes like treatment of obsessive-compulsive disorder, bulimia nervosa, and alcoholism, although it is not FDA-approved for any of these indications. Unfortunately, both Topiragen and Topamax may be associated with the development of major birth defects among infants. According to recent research, women who take these anticonvulsant drugs while pregnant may significantly increase their risk of giving birth to infants with one or more major birth defects, including cleft lip, cleft palate, and genital defects like hypospadias.

Topiragen Described

Topiragen is an anticonvulsant medication prescribed for the treatment of epileptic seizures, particularly generalized tonic-clonic seizures and partial onset seizures, as well as the prevention of migraine headaches. Topiragen can be taken by itself to treat seizures in adults and children ages ten and older, or in combination with other medications to treat seizures in adults and children who are at least two years old. Topiragen has only been approved for the prevention of migraines in adults. Although it will not treat a migraine headache once it occurs, Topiragen can prevent migraines from occurring and can also decrease the intensity of migraine headaches. Topiragen is taken in oral form and can be found in 25mg, 50mg, 100mg, and 200mg tablets. The active ingredient in Topiragen is topiramate, which functions by decreasing the firing of certain impulses in the brain which are responsible for causing seizure-related episodes. Topiramate is also the active ingredient in the anticonvulsant drug, Topamax, which is manufactured by Johnson & Johnson. Topiragen was approved as Topamax (topiramate) by the FDA in 1996 and is currently manufactured by Upsher-Smith Laboratories, Inc.

Topiragen and Birth Defects

According to recent studies, the active ingredient in Topiragen and Topamax, topiramate, has been associated with an increased risk of adverse side effects, particularly birth defects among infants exposed to the drug in utero. Among these birth defects are craniofacial malformations like cleft lip and cleft palate, as well as genital defects like hypospadias. Each of these birth defects can result in considerable complications for an affected child, which may require intensive treatment, including reconstructive surgery and long-term medical care.

Cleft lip is a congenital birth defect affecting the formation of an infant’s lip in utero. Under normal circumstances, the lips are fully formed after the fifth or sixth week of pregnancy. However, if the lip fails to fuse together completely because of a lack of tissue in the upper lip area, a cleft lip may occur. A cleft lip is characterized by a vertical fissure in one or both sides of the upper lip which can vary in severity from a small notch in the lip to a severe opening which may extend up through the nose.

Similar in nature to a cleft lip is a cleft palate, which is a congenital birth defect characterized by a malformation of a child’s palate during fetal development. Where there isn’t enough tissue in the roof of the mouth as the cells are fusing together, the palate may fail to fully form, resulting in an opening in one or both sides of the mouth. A cleft palate can affect the soft back portion of the mouth or the bony front portion of the mouth. The degree of damage caused by a cleft palate can range from a small opening in the back of the mouth to a significant separation of the roof of the mouth. Cleft lip and cleft plate can both cause feeding difficulties, chronic ear infections, hearing loss, missing or malformed teeth, and speech and language delay.

Hypospadias is a genital birth defect in which the opening of the urethra is located on the underside, rather than at the end, of the penis. The opening may also be at the base or the midshaft of the penis, or even in or behind the scrotum. Genital birth defects like hypospadias can cause an affected child to suffer from abnormal spraying during urination, a malformed foreskin, and may cause difficulties with toilet training and sexual intercourse later in life.

Topiragen Birth Defect Studies

According to the FDA, after reviewing data collected by the North American Antiepileptic Drug Pregnancy Registry in 2011, 1.4% of infants exposed to Topiragen and Topamax ingredient, topiramate, during the first trimester of pregnancy were born with cleft palate or cleft lip, compared to the prevalence among infants exposed to other anticonvulsant drugs (0.38-0.55%), and the prevalence among infants whose mothers had no anticonvulsant treatment, which was 0.07%. Shortly after this information was released, the FDA issued a safety announcement regarding the potential link between the use of topiramate or Topamax during pregnancy and the risk of oral malformations like cleft lip and cleft palate.

In 2008, a study was published in the journal Neurology which researched the potential adverse side effects associated with Topamax use during pregnancy. According to researchers, infants whose mothers took Topamax while pregnant were significantly more likely to suffer from birth defects compared to infants who were not exposed to the drug in utero. Of the 178 infants included in the study, sixteen were born with major birth defects. Among these sixteen infants, three of the mothers were taking Topamax by itself and thirteen were taking Topamax in combination with other anticonvulsant drugs. The affected infants included four male children who were born with genital defects like hypospadias, a rate fourteen times higher than what would normally be expected. In addition, four infants were born with cleft palate or cleft lip, a percentage eleven times that among the general population.

Even more revealing, researchers indicated that the rate of birth defects was even higher among infants born to women who took Topamax or topiramate in combination with valproate, the active ingredient in the anti-epileptic drug Depakote. According to the Neurology study, the overall birth defect rate among infants exposed to Topamax in utero was 4.8%, significantly higher than the rate among unexposed infants, which is one to 2.5%.

Topiragen Use and Pregnancy

Topiragen contains the same active ingredient as the anticonvulsant drug Topamax, for which the FDA recently increased the pregnancy category from C to D, meaning the drug has the potential to cause significant, unreasonable harm to a human fetus if taken during pregnancy. Topiragen has also been classified as a pregnancy category D medication based upon positive evidence of fetal risk in human studies, and should only be prescribed to pregnant women if the possible benefits of Topiragen treatment outweigh 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 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 epilepsy or preventing migraine headaches.

Contact a Topiragen Attorney for Help

Research has indicated that women who take Topiragen while pregnant may significantly increase their risk of giving birth to infants with major birth defects, including cleft lip, cleft palate, and genital defects like hypospadias. If you or a loved one has suffered from a major birth defect which you believe to be associated with the use of the anticonvulsant drug, Topiragen, contact a Topiragen attorney to discuss your legal options. According to the FDA, approximately 32.3 million prescriptions for Topamax, Topiragen, or topiramate were filled between January 2007 and December 2010, many of which are now being taken by women of childbearing age. Because nearly half of all pregnancies are unplanned, women of childbearing age who are taking Topamax or Topiragen may cause catastrophic damage to their unborn child before they are even aware they are pregnant. The only way to protect your rights is to hire an experienced Topiragen lawyer to represent your case.

As a potential Topiragen birth defect victim, you may have grounds to file a Topiragen lawsuit against pharmaceutical company, Upsher-Smith Laboratories. The goal of Topiragen lawsuits and potential Topiragen class action lawsuits is to seek financial compensation for your injuries, the medical expenses resulting from treating your injuries, and the pain and suffering endured by you and your family. Topiragen lawsuits or Topiragen class action lawsuits can also help notify the public of the potentially harmful nature of the anticonvulsant drug, Topiragen. Defective drug litigation can be a complex process, but with the help of an experienced Topiragen lawyer, alleged victims of Topiragen birth defects can receive fair reimbursement from the allegedly negligent drug manufacturing company.