Topiramate and Genital Defects

Topiramate is a generic form of the anticonvulsant medication Topamax, which is currently manufactured by Johnson & Johnson. Topiramate functions by inhibiting the firing of impulses in the brain which cause seizure-related episodes. Topiramate was first developed as an anti-epileptic treatment in 1979 and was originally produced by Ortho-McNeil Neurologics and Noramco, Inc., two divisions of Johnson & Johnson. The drug has since become one of the most widely-prescribed forms of anticonvulsant medication on the market, particularly for the prevention of migraines in women of childbearing age, who are significantly more likely to develop this debilitating condition than anyone else. Unfortunately, recent research has identified a possible connection between topiramate use during pregnancy and the development of birth defects in infants exposed to the drug in utero. Among these birth injuries are craniofacial malformations like cleft lip and cleft palate, and genital defects like hypospadias.

Hypospadias Genital Defect

Hypospadias from topiramate is a birth defect affecting the male genitalia in which the opening of the urethra is located on the underside, rather than at the end, of the penis. In some infants, the opening may be located near the tip of the penis, but in others it may be severely misplaced, sometimes located at the midshaft or the base of the penis, and sometimes in or behind the scrotum.

Complications of Hypospadias

Children with hypospadias may have a malformed foreskin which causes the penis to look hooded, and may experience abnormal spraying during urination, forcing them to sit down to urinate. Without treatment, this condition may cause a child to have difficulty toilet training and may result in problems with sexual intercourse later in life.

Treatment for Hypospadias

Infants who are born with hypospadias typically undergo surgery before they are eighteen months old, but in many cases, the surgery is performed before they are even four months old. During the surgical procedure, the penis is straightened and the malformation is repaired using tissue grafts from the child’s foreskin.

Topiramate and Birth Defects

According to an influential study published in the journal Neurology in 2008, the use of topiramate during pregnancy may cause infants to develop one or more Topamax birth defects, including cleft lip, cleft palate and certain genital defects like hypospadias. The study involved 203 pregnant women who took topiramate alone or in combination with another anticonvulsant medication during pregnancy. Of the 178 live births, four infants developed genital defects like hypospadias, a rate fourteen times the expected average. In addition, four infants were born with oral defects like cleft lip and cleft palate, a percentage eleven times what would be expected among the general population. According to researchers, infants born to women who took topiramate in combination with another anti-epileptic drug had a higher rate of birth defects, and the birth defect rate was highest among women who took generic Topamax with valproate, the active ingredient in the anticonvulsant drug, Depakote.

Data collected by the North American Antiepileptic Drug Pregnancy Registry also indicates a potential connection between topiramate use while pregnant and birth defects in infants exposed to the drug in utero. Researchers indicate that the rate of birth defects like cleft lip and cleft palate among infants exposed to topiramate during pregnancy is 1.4%, compared to the rate among infants exposed to a different anti-epileptic drug, which is 0.38-0.55%, and the rate among infants exposed to no anticonvulsant drugs during pregnancy, which is 0.07%.

On the heels of this research came an FDA safety announcement warning health care professionals and patients about the alleged link between topiramate use and the development of cleft lip and cleft palate in infants. The FDA also increased the pregnancy category of topiramate from C to D, which means the drug has the potential to cause significant, unreasonable harm to a human fetus.

Topiramate Use and Pregnancy

If you are currently taking topiramate and you are pregnant or planning to become pregnant, consult your physician immediately. The FDA has advised doctors against prescribing topiramate to pregnant women unless all other available treatment options have failed and their medical condition has the potential to cause permanent injury or death. You should never stop taking a prescription medication without medical consent, but with your doctor’s help, you may be able to find a safer alternative to topiramate for treating your migraine headaches or epileptic seizures.

Contact a Topiramate Attorney for Help

If you or a loved one has suffered from a birth defect like hypospadias or any other Topamax side effect and you believe the anti-seizure medication, topiramate, to be the cause, you may have grounds to file a topiramate lawsuit in order to receive reimbursement for your injuries. The goal of topiramate lawsuits and potential topiramate class action lawsuits is to seek financial compensation for your injuries, the medical expenses associated with treating the injury or injuries, and the pain and suffering sustained by you and your family. By filing a topiramate lawsuit or topiramate class action lawsuit, victims of alleged topiramate birth defects can bring public attention to the importance of safe medications and the need for more strict regulations on the potentially dangerous drugs already on the market. The only way to hold the allegedly negligent pharmaceutical company accountable for your injuries is to file a topiramate lawsuit.

Victims of alleged topiramate side effects and birth injuries are not at fault and should not be held responsible for the medical costs incurred as a result of the injury. The only way to ensure that your rights as a victim are protected is to contact a topiramate attorney to represent your case. Topiramate lawyers are extremely experienced in defective drug litigation and have the knowledge and skill necessary to help alleged topiramate birth defect victims collect the compensation they are entitled to. After a birth defect diagnosis, the victim and his family should be given the time to concentrate on treating the birth defect and providing proper care, without having to worry about developing a birth injury case. With the help of a qualified topiramate lawyer, potential victims of topiramate birth defects can feel confident that their case is in good hands.