Topamax Side Effects in Children

Topamax belongs to a class of prescription medications called anticonvulsants, drugs which were originally developed as the primary treatment method for people with epilepsy. Once these drugs were proven successful in treating epilepsy, the FDA approved additional indications for specific anticonvulsant medications. Furthermore, some physicians choose to prescribe anticonvulsant drugs for off-label purposes if they believe the treatment appropriate. Topamax was initially approved by the FDA in 1996 to treat generalized tonic-clonic and partial onset epileptic seizures, until the FDA approved the drug in 2004 for the prevention of migraine headaches as well. Although the drug cannot treat a migraine once it occurs, Topamax may be able to decrease the frequency and intensity of migraines, which can be an extremely debilitating condition. Topamax (topiramate) is currently manufactured by Ortho-McNeil Pharmaceutical, a division of Johnson & Johnson, and the drug works by slowing down certain impulses in the brain responsible for causing seizures.

According to FDA estimates, approximately 32.3 million Topamax or generic Topamax prescriptions were filled between January 2007 and December 2010. It is likely that many of these prescriptions were filled by pregnant women suffering from migraines, a condition that affects three times more women than men, especially women of childbearing age. Unfortunately, after reviewing information gathered by the North American Antiepileptic Drug (NAAED) Pregnancy Registry and significant studies published in the New England Journal of Medicine and the journal Neurology, the FDA has voiced concerns about the potential for serious Topamax side effects in children exposed to Topamax in pregnancy.

Topamax Side Effects in Children

In 2001, the NEJM published a study in which researchers sought to examine the adverse effects of fetal exposure to anticonvulsant drugs like Topamax. When the study was complete, researchers concluded that anticonvulsant drugs are one of the most common causes of potential harm to a fetus in utero. In more recent studies, the potentially harmful nature of Topamax has been more specifically defined, revealing an increased risk of Topamax side effects in children whose mothers took the drug while pregnant. Among these alleged Topamax birth defects are:

  • Cleft palate
  • Cleft lip
  • Hypospadias

Cleft lip and cleft palate are craniofacial malformations affecting the formation of a child’s oral structures in utero. When there isn’t enough tissue in the lip or palate area during fetal development, they may be unable to form properly, resulting in a cleft. A cleft palate is characterized by an opening in the palate which can vary in severity from a small hole at the back of the mouth to a nearly complete separation of the roof of the mouth. A cleft lip presents as a vertical fissure in one or both sides of the upper lip which can range from a minor notch in the lip to a severe opening which may extend up through the nose. Either of these potential Topamax side effects in children can lead to serious complications if left untreated, including:

  • Feeding difficulties
  • Recurring ear infections
  • Hearing loss
  • Speech and language delay

Hypospadias is a genital birth defect affecting male infants, in which the opening of the urethra is located on the underside of the penis, rather than at the end. Instances of hypospadias can vary in severity from an opening located near the tip of the penis, but on the underside, to more severe cases in which the opening is located at the midshaft or base of the penis, or even in or behind the scrotum. Infants born with hypospadias may suffer from significant complications if the defect is left untreated, including:

  • Abnormal spraying of urine
  • A malformed foreskin which makes the penis look hooded
  • Having to sit down to urinate
  • Difficulties during toilet training
  • Problems with sexual intercourse later in life

Topamax Side Effect Studies and FDA Warnings

The FDA has issued a safety announcement warning patients and physicians about the increased risk of oral clefts (cleft lip and cleft palate) among infants exposed to topiramate or Topamax in pregnancy. This decision was made based on data gathered by the NAAED Pregnancy Registry which indicated that infants exposed to Topamax in utero had a significantly higher rate of birth defects like cleft lip and cleft palate, compared to other infants. According to the registry, the prevalence of oral clefts among infants exposed to Topamax in pregnancy was 1.4%, compared to the prevalence among infants exposed to other anticonvulsant drugs (0.38-0.55%), and the prevalence among infants not exposed to any anticonvulsant drugs, which was 0.07%. In 2008, the journal Neurology published a study in which researchers also found an increased risk of Topamax side effects in children exposed to the drug during pregnancy. According to researchers, infants whose mothers took Topamax in pregnancy were eleven times more likely to be born with cleft lip or cleft palate, and fourteen times more likely to develop genital defects like hypospadias.

Alleged Dangers of Topamax in Pregnancy

The FDA has increased the pregnancy category of Topamax from C to D, a category reserved for medications which positive human evidence has shown may cause serious harm to a fetus when taken during pregnancy. The FDA has also advised physicians to avoid prescribing Topamax to pregnant women unless the possible benefits of the treatment justify the potential risks to the fetus. If you are currently taking Topamax and you are pregnant or planning to become pregnant, consult your physician immediately. It may be dangerous to discontinue use of a prescription medication without medical consent, as this may cause further harm to you or your child. However, with your doctor’s help, you may be able to find a safer way to treat your medical condition.

Topamax Attorneys for Topamax Side Effects in Children

According to extensive and credible research, women who take Topamax in pregnancy may be at risk of giving birth to infants with serious birth defects. If you or a loved one has suffered from a birth defect and you believe Topamax to be the cause, contact a Topamax attorney to discuss your legal options. You may be entitled to financial compensation for your injuries, medical expenses, and pain and suffering, which you can collect by filing a Topamax lawsuit or join a potential Topamax class action lawsuit against Ortho-McNeil Pharmaceutical (Johnson & Johnson). The goal of Topamax lawyers is to help victims of alleged Topamax side effects collect the compensation they deserve while also protecting their rights against deceptive drug companies and misleading insurance claims adjusters. The potential for Topamax to cause serious side effects in children is still being investigated; in the meantime, pregnant women should avoid taking Topamax unless all other available treatment methods have failed. Only by hiring an experienced Topamax attorney can victims of alleged Topamax birth defects feel confident that their Topamax lawsuit is being effectively and professionally represented.