Topiragen and Genital Defects

Topiragen is a prescription anticonvulsant medication currently manufactured by Upsher-Smith Laboratories. The drug was approved as Topamax (topiramate) by the FDA in 1996 and has since become one of the most commonly prescribed anticonvulsant drugs on the market. Unfortunately, several studies in recent years have indicated a possible link between the use of Topamax and Topiragen and the development of major birth defects among infants exposed to the drugs in utero. These birth defects include craniofacial birth defects like cleft lip and cleft palate, and genital defects like hypospadias.

Topiragen has been FDA-approved for the treatment of epileptic seizures, specifically tonic-clonic and partial onset seizures, as well as the prevention of migraine headaches. The active ingredient in Topiragen is topiramate, which functions by slowing down the firing of certain impulses in the brain, thereby decreasing the frequency of seizure-related episodes. According to the FDA, approximately 32.3 million prescriptions for Topamax, Topiragen, and generic forms of the drugs were filled between January 2007 and December 2010. With the discovery of the potential connection between Topiragen use during pregnancy and birth defects, individuals who are currently pregnant and taking Topiragen may be advised to seek alternative treatment options.

Hypospadias Described

Hypospadias is a genital birth defect in which the opening to the urethra of an affected male is located on the underside of the penis, rather than at the end. In some cases, the opening may be located near the tip of the penis, but on the underside. In more serious instances, the opening may be located at the midshaft or the base of the penis, or even in or behind the scrotum.

Treatment and Complications of Hypospadias

There are several complications associated with hypospadias which may plague an affected infant, including the abnormal spraying of urine which may force a child to sit down to urinate, and a malformed foreskin which makes the penis look hooded. In order to treat hypospadias, infants typically undergo surgery before they are eighteen months old, during which the penis is straightened and the malformation is repaired with tissue grafts from the infant’s foreskin. Treatment for hypospadias is essential; without it, affected infants may suffer from additional difficulties with toilet training and sexual intercourse later in life.

Topiragen and Birth Defects

A significant study was published in the journal Neurology in 2008 which identified Topamax use during pregnancy as a risk factor for the development of birth defects like cleft palate, cleft lip and genital birth defects like hypospadias. The study involved 203 women who became pregnant while taking Topamax. According to researchers, of the 178 live births observed, sixteen infants were born with major birth defects. Of the mothers of these sixteen children, three took Topamax by itself while pregnant, and thirteen took Topamax in combination with another anticonvulsant drug. Among the affected infants, four were born with cleft lip or cleft palate and four were born with genital defects like hypospadias. The prevalence of oral defects was eleven times what would be considered normal among the general population, and the prevalence of genital defects was fourteen times normal. The study also indicated that the birth defect rate was even higher among infants born to women who took Topamax with valproate, the active ingredient in the anticonvulsant drug, Depakote.

Even more revealing is data collected by the North American Antiepileptic Drug Pregnancy Registry, which indicated that infants who are exposed to Topamax during the first trimester of pregnancy may have a significantly increased risk of developing oral birth defects like cleft lip and cleft palate. According to the registry, the prevalence of these craniofacial defects was 1.4% among infants exposed to Topamax in utero, compared to the rate among infants exposed to another anticonvulsant drug, which was 0.38-0.55%, and the prevalence among unexposed infants, which was 0.07%.

Topiragen Use During Pregnancy

After reviewing the data collected by the North American Antiepileptic Drug Pregnancy Registry, the FDA increased the pregnancy category of topiramate from C to D. This means that there is positive evidence regarding the potential for the drug to cause significant harm to a human fetus. If you are currently taking Topiragen and you are pregnant or planning to become pregnant, consult your physician as soon as possible. It may be unsafe to discontinue use of a prescription medication without medical consent, but the FDA has advised physicians to avoid prescribing Topiragen to pregnant women unless the possible benefits of Topiragen treatment justify the potential risks to the fetus.

A Topiragen Attorney Can Help

Victims of serious injuries potentially resulting from the use of an allegedly dangerous drug are not at fault and may be entitled to reimbursement by filing a Topiragen lawsuit against pharmaceutical company, Upsher-Smith Laboratories. If you or a loved one has suffered from a birth defect like hypospadias and you believe the anticonvulsant drug, Topiragen, to be the cause, contact a Topiragen attorney to discuss your legal options. The goal of Topiragen lawsuits and potential Topiragen class action lawsuits is to seek financial compensation for your injuries, the medical expenses resulting from injury treatment, and the pain and suffering incurred by you and your family. Some pharmaceutical companies market drugs with their own best interests in mind, disregarding the safety of potential consumers of their products. The only way to protect your rights and collect the compensation you deserve is to hire a knowledgeable Topiragen lawyer to represent your case.

Following a birth defect diagnosis, victims’ families should be given adequate time to concentrate on seeking proper medical care for their child and should be permitted to focus their attention on caring for the needs of the child. They should not have to worry about collecting evidence in order to develop a birth defect case as well. Fortunately, Topiragen lawyers are experienced in defective drug litigation and have the resources necessary to put together a strong birth defect case. With the help of a Topiragen attorney, alleged Topiragen birth defect victims can collect the compensation they deserve.