Topamax Birth Defects

Stueve Siegel Hanson is investigating the drug Topamax. Topiramate is the brand name for Topamax and was originally produced by Ortho-McNeil Neurologics and Noramco, Inc., both divisions of Johnson & Johnson. It was discovered in 1979 by Bruce E. Maryanoff and Joseph F. Gardocki during their research work at McNeil Pharmaceutical. Generic versions are available in Canada and were FDA approved in September 2006.

Topamax is used to treat certain forms of epilepsy and for the prevention of migraines in adults and children ten years and older. Topamax comes in two oral forms – a pill form and a powder form that individuals can sprinkle on food. This drug works by suppressing the signals that nerves send to trigger seizures, in the case of epilepsy, and pain, in the case of migraines. Topamax is sometimes used on an off-label basis to treat other conditions, such as obesity, bipolar disorder and alcoholism.

Side Effects

Topamax has generic side effects common in many drugs. These side effects include:

  • Nausea
  • Diarrhea
  • Loss of appetite
  • Numbness and tingling
  • Memory problems

In addition to these side effects, a FDA warning was issued on March 4, 2011, stating that Topamax may increase the risk of birth defects when expecting mothers take the drug during pregnancy.

Birth Defects

Topamax has been linked to severe birth defects including cleft lip and cleft palate, affecting the upper lip and the roof of the mouth. Topamax increases the rate of oral cleft birth defects from 0.07% to 1.4%. On March 4, 2011, the Food and Drug Administration issued a warning to providers and patients of the higher incidence of birth defects. Based on reports of the increased risk of birth defects, the FDA has issued a Topamax warning and changed the pregnancy category from C to D which means there is positive evidence of fetal risk based on human data.

The North American Antiepileptic Drug (NAAED) Pregnancy Registry release data that prompted the FDA's warning. Their statistics show that, while children born to mothers who do not have epilepsy and are not taking an anti-epileptic drug suffer oral clefts only 0.07% of the time, babies born to mothers taking Topamax experience cleft lip and cleft palate at a rate of 1.4%. Children whose mothers have epilepsy, and are taking a drug other than Topamax or containing topiramate, have an incidence of 0.38-0.55% of oral clefts.

Cleft lip and cleft palate are two kinds of birth defects known as "oral clefts." While the majority of cases are resolved with reconstructive surgery, some severe cases of cleft palate lead to problems with eating, talking, and ear infections. Normally, the upper lip and palate meet and fuse together during the first trimester of pregnancy, a time unfortunately when many women do not yet realize they are pregnant. As a result, some mothers are unable to prevent exposure to Topamax until later in their pregnancies, when the oral cleft birth defect has already formed.

Because Topamax may reduce the effectiveness of oral contraceptives and therefore increase the risk of unexpected pregnancy, women who are not advised to take additional preventative measures to ensure contraception against pregnancy before taking this drug may become pregnant with a fetus at risk of birth defects. The FDA does not prohibit doctors from prescribing Topamax to pregnant women or women of childbearing age, but allows doctors to decide if benefits outweigh risks. There are alternative medications, however, that do not carry the same risks as these Topamax birth defects. People should not stop taking Topamax without consulting with their doctor.

If you are currently taking this drug and experiencing any of the side effects below or are concerned about the risks of birth defects for your unborn child, it is important to consult with a doctor.

Pharmaceutical companies have a responsibility to produce safe and effective drugs that do not pose a health risk to patients.  When they fail to do so, they may be held liable for any negative side effects that result. If you have experienced the serious birth defects outlined above, or have had a child who suffered from the serious birth defects outlined above, caused by Topamax and wish to receive additional information about your legal options, please call 1-888-756-6494 or fill out the form on this page.

 

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