Topamax is a prescription anticonvulsant drug manufactured by Ortho-McNeil Pharmaceutical, a subsidiary of Johnson & Johnson. The drug was originally approved by the FDA in 1996 for the treatment of generalized tonic-clonic and partial onset seizures associated with epilepsy, and the FDA added an indication for the prevention of migraine headaches in 2004. The active ingredient in Topamax is topiramate, and the drug functions by interfering with certain impulses in the brain which are responsible for causing seizure episodes. Topamax is often used alone as monotherapy or in combination with other anticonvulsant drugs to treat epilepsy. Since its introduction to the U.S. market, Topamax has become one of the most commonly prescribed anticonvulsant drugs available. Unfortunately, recent research has identified Topamax use during pregnancy as a potential risk factor for the development of major birth defects in infants. Among these birth defects is a congenital defect called hypospadias.
Hypospadias is a genital defect affecting male infants in which the opening of the urethra is located on the underside, rather than at the end, of the penis. Hypospadias can vary in severity, depending on the location of the opening. In most cases, the opening is located near the end of the penis, but on the underside. More serious forms of this condition occur when the opening is at the mid-shaft or the base of the penis. In some cases, the opening may even be located in or behind the scrotum.
Infants with hypospadias may experience a downward curvature of the penis, abnormal spraying during urination, having to sit down to urinate, and a malformed foreskin which makes the penis look hooded. Children with hypospadias require reconstructive surgery in order to repair the defect, a procedure which is typically performed before the child is eighteen months old. During surgery, the child’s penis is straightened and the hypospadias is corrected using tissue grafts from the child’s foreskin. In some cases, the child may require several surgeries in order to fully correct the malformation. Infants with hypospadias who undergo surgery typically make a full recovery. However, if this condition is left untreated, the child may suffer from additional issues, including difficulty during toilet training and problems with sexual intercourse later in life.
New data has been collected by the North American Antiepileptic Drug (NAAED) Pregnancy Registry and reviewed by the FDA. According to this information, infants whose mothers took Topamax during pregnancy had a twenty-times increased risk of being born with cleft lip or cleft palate, compared to infants whose mothers received no anticonvulsant treatment while pregnant. Infants exposed to Topamax were also three to four times more likely to develop an oral cleft than infants exposed to other anticonvulsant drugs. More specifically, the prevalence of oral clefts among infants exposed to Topamax was 1.4%, compared to 0.38-0.55% among infants exposed to other anticonvulsant drugs, and 0.07% among infants exposed to no anticonvulsant drugs in utero.
In 2008, the journal Neurology published a revealing study in which researchers found a connection between Topamax use during pregnancy and the development of cleft lip, cleft palate, and genital defects like hypospadias among infants. The study involved 178 women who became pregnant while taking Topamax. According to the report, sixteen infants were born with major birth defects, three of which were exposed to Topamax alone in utero and thirteen of which were exposed to Topamax in combination with another anticonvulsant drug. Of the sixteen affected infants, four were born with cleft lip or cleft palate, a prevalence eleven times what would be expected among the general population, and four were born with genital defects like hypospadias, a rate fourteen times what would be expected.
The FDA has elevated the pregnancy category of Topamax from C to D, which means there is positive human evidence regarding the drug’s potential to cause serious harm to a fetus when taken during pregnancy. If you are currently taking Topamax and you are pregnant or planning to become pregnant, consult your physician immediately. 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 Topamax for treating your medical condition.
Children born with hypospadias typically struggle with a number of complications associated with the defect, and some children require multiple surgeries in order to correct the malformation. Unfortunately, this may result in costly medical expenses, which can be an overwhelming burden for a family already physically and emotionally distressed by a birth defect diagnosis. If you or a loved one has suffered from hypospadias and you believe Topamax to be the cause, contact a Topamax attorney to discuss your legal options. You may be entitled to reimbursement for your injuries, which you can collect by filing a Topamax lawsuit against Ortho-McNeil Pharmaceutical, a subsidiary of Johnson & Johnson.
Pharmaceutical companies are responsible for the safety of their medications even after they enter the market, and should be held accountable for any adverse side effects sustained by consumers of their products. Unfortunately, some drug manufacturing companies intentionally conceal the more serious side effects of their medications in order to expedite the FDA approval process and make sure their drug is well-received by the public. This puts consumers at risk of suffering catastrophic injury, illness and even death, which could have been avoided had the appropriate steps been taken by the pharmaceutical company. The only way to protect your rights and collect the compensation you deserve is to hire a Topamax lawyer to represent your case.