Topamax® (Topiramate)

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Topamax® Birth Defect Lawsuit

Our attorneys are investigating Topamax® (topiramate) birth defect lawsuits for parents’ of babies born with cleft lip/palate. To schedule a free and confidential evaluation of your case, contact us today.

Topamax® Cleft Lip and Cleft Palate

The antiepileptic drug Topamax® increases the risk of birth defects of cleft lip and cleft palate (roof of the mouth) in children born to mothers taking the drug during their pregnancy. The U.S. Food and Drug Administration (FDA) issued a news release March 4, 2011warning of the risk.

Topamax® (topiramate) is prescribed to decrease the frequency of seizures in people who have epilepsy. It also is prescribed to prevent migraines, although it will not treat a migraine once the headache has begun.

The FDA release advised pregnant women and women of childbearing age to discuss other treatment alternatives before starting Topamax®. Women who are taking Topamax® and become pregnant or are planning to become pregnant should talk with their doctors immediately, the FDA advised.

New research from the North American Antiepileptic Pregnancy Registry shows that Topamax® increases the risk of oral clefts (cleft lip and cleft palate) in fetuses exposed to the drug early in their mother’s first trimester of pregnancy.

According to the new data, the risk of being born with oral clefts is:

1.4 percent in children born to mothers taking Topamax®
0.7 percent in infants born to mothers who were not epileptic or not taking any antiepileptic medication
0.38 to 0.55 percent for infants exposed to antiepileptics other than Topamax®

Because of the new data, a stronger warning will be added to the label of Topamax®. In addition, the pregnancy category of the drug will be changed from a Pregnancy Category C to a Pregnancy Category D. Category D means the clinical data confirm that the drug causes birth defects in humans (as opposed to causing birth defects in animals during experiments).

Prescribing information and the patient medication guide will be updated with the new information and warnings.

Cleft Lip/Palate Information

Cleft lip/palate is among the most common birth defects. About one in 1,000 infants are born with the condition. There can also be cleft lip alone without cleft palate, or cleft palate alone without cleft lip.

Cleft lip/palate:

constitute about 50 percent of all clefts
occur more often in Asians and some American Indian groups
occur less often in African Americans
make up to 13 percent of children who also have other birth defects
occur more often in males

Is My Baby at Risk?

If you have taken Topamax® early in the first trimester of your pregnancy, yes, your baby is at risk of being born with a cleft lip or cleft palate or both. If you are taking Topamax® now and are pregnant, you should speak with your doctor immediately. You should not stop taking Topamax® without talking with your doctor first.