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Important Update: Topamax® has been linked to the development of cleft lip and cleft palate in some infants whose mothers are treated with the epilepsy medication while pregnant. To speak with an attorney, contact us today.

What Is Topamax®?

Topamax® is a medication prescribed alone or in addition to other medications to treat epilepsy in patients with certain kinds of seizures. It also is prescribed to prevent migraine headaches but does not relieve the pain of migraines once they have begun.

The drug comes in the form of tablets or sprinkle capsules. The latter are capsules that can be opened and the contents sprinkled on a spoonful of soft food.

Topamax® Side Effects

The most common adverse reactions to Topamax® found in controlled clinical trials in epilepsy patients are:

• Tingling or prickling sensations on the skin
• Loss of appetite
• Weight loss
• Fatigue
• Dizziness
• Sleepiness
• Nervousness
• Psychomotor slowing
• Memory problems
• Concentration/attention problems
• Confusion

In patient with migraines, the most common adverse reactions in controlled clinical trials are:

• Tingling sensations on skin
• Effect on taste

Topamax® Birth Defects

New research data show that Topamax® and its generic equivalents increase the risk of a baby being born with cleft lip and/or cleft palate if their mothers take Topamax® during their pregnancies. The news came in a U.S. Food and Drug Administration (FDA) announcement released March 4, 2011.

"Health care professionals should carefully consider the benefits and risks of topiramate [the generic version of the drug] when prescribing it to women of childbearing age," said Dr. Russell Katz, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.

"Alternative medications that have a lower risk of birth defects should be considered," he said.

How Does Cleft Lip Occur?

Cleft lip and cleft palate occur early in the first trimester of pregnancy, when many women do not know they are pregnant. When this defect happens, the lip and the palate in the roof of the mouth do not close completely as they normally do during this early stage of the fetus' development.

These defects can be as small as a notch in the lip or as large as a groove that travels from the lips into the roof of the mouth and nose. A severe cleft lip and palate can cause problems with eating and speaking and lead to ear infections. Surgery is a common and usually successful way to treat these problems.

Because these birth defects can occur before a woman knows she is pregnant, it is suggested that women who have epilepsy and are taking Topamax® also use a contraceptive.

If your baby is born with a birth defect such as cleft lip or cleft palate, our Topamax® birth defect lawyers can help you. Contact us for an evaluation of your case.

"Topamax® May Cause Birth Defects, Says FDA"

The FDA notified healthcare professionals and patients about a possible connection between Topamax® and certain birth defects. The agency sent a letter...

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