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Topamax Birth Defect Lawyers

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Topamax is an anticonvulsant drug produced by Ortho-McNeil Neurologics, a division of Johnson & Johnson.  Generic versions of Topamax were approved by the Food & Drug Administration (FDA) in 2006. Topamax is approved  to treat epilepsy in adults and children, as well as migraine headaches.  It is also used off-label to treat bipolar disorder.

When it was approved, Topamax received a pregnancy category C classification from the FDA, which means the drug hasn't been studied in pregnant women, though it appears to cause harm to the fetus in animal studies. The drug caused birth defects, miscarriages, and decreased fetal weight in rabbits, rats and mice, according to the U.S. prescribing information.  The Topamax birth defect lawyers at our firm believe that given the evidence of fetal harm in animal studies, the maker of Topamax should have performed more studies to determine its effects on human fetuses, and it should have provided stronger warnings about the possible danger.

In the years since receiving FDA approval for the treatment of migraines, Topamax has become one of the most widely prescribed drugs for the condition, which affects almost 30 million Americans. Women are three times more likely to suffer from migraines than men; women in their childbearing years are particularly vulnerable.  Our Topamax birth defect lawyers believe the widespread use of this drug for migraines by women of child bearing age may have contributed to the occurrence of birth defects in thousands of children.

Topamax Birth Defect Study

The "Neurology" Topamax study was conducted by researchers at the Royal Group of Hospitals in Belfast, Northern Ireland.   It looked at 203 women who became pregnant while taking Topamax for the treatment of epilepsy and found that the risk of birth defects increased by as much as 14-fold.   The risk for birth defects was especially high in women who took Topamax in combination with another epilepsy drug, valproate.

Of the 178 live births that occurred, three babies whose mothers took Topamax alone and 13 whose mothers took Topamax along with other anti-epilepsy drugs had major birth defects.  Those other drugs included Frisium, Sabril, Epilim or Depakine, Zarontin, Keppra as well as generic drugs carbamazepine, phenobarbitral or phenytoin.

Four of the babies had cleft palates or cleft lips, which was 11 times higher than would be expected among women not taking epilepsy medication. Four male babies had genital birth defects, with two of these classified as major birth defects. Minor defects included a hole above the buttocks, a flattened head, toe webbing, clicky hips and immature hip joints. The birth weights weren't significantly lower than in the normal population.

 Drugs to treat epilepsy are known to increase the chance of miscarriage and birth defects. Still, women suffering from epilepsy need to take the medicines to prevent seizures that can harm the fetus. The researchers said that the birth defect rate associated with Topamax in their study was in line with those of other anti-seizure drugs, though a larger study is needed to draw definitive conclusions.

However, more birth defects occurred in women taking Topamax along with the drug valproate, or valproic acid, than in women taking other epilepsy drugs or other Topamax drug combinations. Valproate is sold as Depakote by Abbott Laboratories and as Depakine by Sanofi- Aventis. Previous research has shown that valproate is associated with an increased risk of birth defects such as heart defects and spina bifida.  Because the risk of birth defects associated with valproate is already well known, our Topamax birth defect lawyers believe that doctors who treated pregnant  women with a Topamax-valproate combination may be liable for medical negligence.

Although the "Neurology" study was small, it was the first to link Topamax to birth defects in humans, and confirmed earlier animal studies that showed evidence of fetal harm.    The researchers who conducted the study said that the connection between Topamax and birth defects warrants further study.  Three major databases currently track birth defects among babies born to women taking epilepsy drugs, but only one has so far provided information on Topamax.  When the other databases report, the extent of Topamax's association with birth defects should become  clearer.

For now, many experts are advocating that Topamax use in women who plan on conceiving should be restricted to those in whom the drug is definitely needed for seizure control or other indications. Also, the mother should be informed of the potential risks to her child.

Legal Help for Victims of Topamax Birth Defects

If you or a loved one has given birth to a child who suffers from birth defects that might be the result of Topamax use, you have valuable legal rights.  Please fill out our online form or call 1-800-LAW-INFO  (1-800-529-4636) to discuss your case with an experienced Topamax birth defect lawyer.