Topiragen Side Effects

Topiragen belongs to a group of prescription medications called anticonvulsants, which function by slowing down the firing of certain impulses in the brain which are responsible for causing seizure-related episodes. In 1996, the FDA approved Topiragen for the treatment of generalized tonic-clonic seizures and partial onset seizures associated with epilepsy. In 2004, the FDA added an indication for the prevention of migraine headaches as well. The active ingredient in Topiragen is topiramate, identical to the active ingredient in the anticonvulsant drug, Topamax. Topiragen (topiramate) can be used alone as monotherapy or in combination with other anticonvulsant drugs in order to prevent epileptic seizures. Topiragen is currently manufactured by pharmaceutical company, Upsher-Smith Laboratories, Inc.

Potential Topiragen Side Effects

Although both Topiragen and Topamax have become increasingly popular in the treatment of epilepsy in recent years, research has raised concerns regarding the safety of the medication, especially in treating pregnant women. According to a number of studies, the use of anticonvulsant drugs like Topiragen may cause serious adverse side effects, including the development of one or more major birth defects among infants exposed to the drugs during pregnancy. Because of the severity of these alleged Topiragen side effects, the FDA has advised physicians to avoid prescribing Topiragen (topiramate) to pregnant women unless the possible benefits of the drug justify the potential risks to the fetus.

Topiragen and Birth Defects

Unfortunately, many birth defects are already established during the first trimester of pregnancy. This means that a woman of child-bearing age who takes anticonvulsant drugs may cause irreversible harm to her unborn child before she is even aware that she is pregnant. Among the birth defects potentially associated with Topiragen are:

  • Cleft lip
  • Cleft palate
  • Genital birth defects like hypospadias

Cleft lip and cleft palate are craniofacial birth defects involving the malformation of a child’s oral structures in utero. During normal fetal development, a child’s lips and palate are fully formed during the first few weeks of gestation. However, when there isn’t enough tissue in the upper lip or palate area during this time, the structure may fail to close completely, resulting in a cleft lip or cleft palate. A cleft lip is characterized by a vertical fissure on one or both side of the lip and can range in severity from a mild notch in the upper lip to a severe crevice extending up through the nose. A cleft palate can affect one or both sides of the mouth and can vary from a small opening at the back of the mouth to a nearly complete separation of the roof of the mouth.

Hypospadias is a congenital birth defect affecting a male infant’s genitals in which the opening of the urethra is located on the underside, rather than at the end, of the penis. In less serious cases, the opening may be located near the tip of the penis, while more severe instances are characterized by an opening located along the mid-shaft or base of the penis, or even in or behind the scrotum. Besides the misplaced urethral opening, common symptoms of hypospadias include a downward curvature of the penis and a malformed foreskin which makes the penis look hooded.

Children born with a cleft lip or cleft palate typically suffer from significant complications associated with the defect, including feeding difficulties, recurring ear infections, hearing loss, speech and language delay, and missing or malformed teeth. The only way to permanently correct this defect is for the child to undergo reconstructive surgery. Infants suffering from hypospadias may struggle with abnormal spraying during urination and having to sit down to urinate. Without treatment, children with this condition may have difficulty during toilet training and sexual intercourse later in life.

Topiragen and Birth Defect Studies

The FDA recently issued a safety announcement warning healthcare professionals and patients alike about the increased risk of craniofacial defects like cleft lip and cleft palate among infants exposed to Topamax (topiramate) during pregnancy. This notice was issued by the FDA after the agency reviewed data collected by the North American Antiepileptic Drug Pregnancy Registry regarding the connection between Topamax use during pregnancy and the development of oral clefts. According to the NAAED pregnancy registry, the prevalence of cleft palate and cleft lip among infants whose mothers took Topamax during pregnancy was 1.4%, compared to the rate among infants exposed to other anticonvulsant drugs, which was 0.38-0.55%, and the prevalence among unexposed infants, which was 0.07%.

According to a study published in the journal Neurology in 2008, infants born to women who took Topamax while pregnant had a significantly increased risk of developing cleft palate, cleft lip and genital defects like hypospadias. The study involved 203 women who became pregnant while taking Topamax and, of the 178 live births, sixteen infants were born with major side effects. Of the sixteen affected infants, three mothers took Topamax by itself during pregnancy and thirteen took Topamax in combination with another anticonvulsant drug. Researchers reported that four of the affected infants were born with cleft lip or cleft palate, a rate eleven times what would be considered normal among the general population. In addition, four infants were born with genital defects like hypospadias, a rate fourteen times what would be considered normal. Furthermore, the birth defect rate was even higher among infants exposed to Topamax in combination with valproate, the active ingredient in the anticonvulsant drug Depakote.

Topiragen Use During Pregnancy

The FDA recently increased the pregnancy category of topiramate, the active ingredient in both Topiragen and Topamax, from C to D, because of the potential for serious Topiragen side effects. Pregnancy category D is reserved for drugs which positive human evidence has shown have the potential to cause significant, unreasonable harm to a human fetus when taken during pregnancy. 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 dangerous to discontinue use of a prescription medication without medical consent, but with your doctor’s help, you may be able to find a safer way to treat your epilepsy.

Contact a Topiragen Attorney for Help

Alleged Topiragen side effects have the potential to cause severe, long-term complications for an affected child. If you or a loved one has suffered from a side effect or 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 or join a potential Topiragen class action lawsuit against Upsher-Smith Laboratories in order to seek financial compensation for your injuries, the medical expenses resulting from injury treatment, and the pain and suffering endured by you and your family.

Victims of serious injury resulting from the proper use of a dangerous drug are not at fault and should not be held accountable for the resulting consequences. Pharmaceutical companies are expected to produce and market safe medications, and are responsible for warning consumers about the adverse side effects associated with their drugs. Unfortunately, some drug manufacturing companies fail to provide this critical warning, leaving consumers vulnerable to serious and even life-threatening side effects. With the help of an experienced Topiragen lawyer, victims of alleged Topiragen side effects can hold the responsible party liable for their injuries and collect the compensation they deserve.