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The U.S. Food and Drug Administration (FDA) on March 4, 2011, notified patients and healthcare professionals that the epilepsy medication Topamax® (topiramate) presented an increased risk of causing birth defects in newborns whose mothers took the drug during pregnancy.

New data showed that Topamax® taken early in a woman’s pregnancy could cause her baby to be born with cleft lip or cleft palate, or both. These are known as oral clefts.

Do You Need an Oral Cleft Lawyer?

Have you taken Topamax® while pregnant and had a child born with a cleft lip or palate? If so, you understand the pain, suffering and expense of having a baby with a birth defect. You should contact an oral cleft lawyer to discuss your particular situation. Your lawyer will be an expert in both the law and birth defects.

About Topamax®

Topamax® (topiramate) was approved in December 1996. It is an anticonvulsant medication meant to be used alone or with other medication to reduce the frequency of certain kinds of seizures in epileptic patients. The medication also is approved to prevent migraine headaches, although it has not been shown if it can relieve the pain of a migraine once it has begun.

About 32.3 million prescriptions for topiramate were written from January 2007 through December 2010.

New Human Statistics on Topamax®

The new data showing the increased incidence of oral cleft in infants born to pregnant mothers taking Topamax® come from the North American Antiepileptic Drug Pregnancy Registry. The prevalence of oral clefts was:

• 1.4 percent in babies born to mothers taking topiramate during pregnancy
• 0.38 to 0.55 percent in infants born to mothers taking other antiepileptics
• 0.07 percent in babies born to mothers who were not epileptic and did not take an anti-seizure medication

Data from the United Kingdom supported the North American registry’s data. The UK Epilepsy and Pregnancy Register reported a 16-fold increase in risk among infants exposed in utero to Topamax® compared to the regular population.

Cleft Lip and Cleft Palate

The lips and palate (the roof of the mouth) of the fetus originally are cleft or separated along the midline of the face until the sixth week of development. Unless something interferes with their fusion, these oral features come together during the next five weeks. Statistics have shown that some babies of women taking topiramate during this gestational period are born with oral clefts.

In addition to labeling Topamax® a potential cause of oral clefts, the FDA changed the pregnancy category of the drug from a Category C to a Category D drug. A Category C drug has been shown in animal studies to cause birth defects. Category D drugs are shown to cause birth defects in humans.

If you or someone you love has taken Topamax® and had a child born with an oral cleft, you should contact a Topamax® cleft lip lawyer. We may be able to help you get compensation for your suffering.

"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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