If your baby was born with an oral cleft and you were taking Topamax® early in your pregnancy, you may have grounds to file a lawsuit against the company that makes the drug, Ortho-McNeil Neurologics. To find out if you qualify, contact a Topamax® lawyer at AWKO law today.

The U.S. Food and Drug Administration (FDA) on March 4, 2011, issued a safety announcement warning that the antiseizure medication Topamax® can cause oral clefts if taken by the mother during the first trimester of her pregnancy.

An oral cleft is a cleft lip, a cleft palate, or both.

Topamax® Information

Data from a number of studies of babies born to epileptic mothers show that a significantly higher percentage of babies had oral clefts if they were exposed to Topamax® than other epilepsy drugs or no drugs at all.

Data show the risk for developing oral clefts was:

• 1.4 percent in infants exposed to Topamax® during the mother's first trimester
• 0.38 to 0.55 percent in infants whose mothers took other anti-seizure medications
• 0.07 percent in babies that are not exposed to epilepsy medications at all

These new statistics prompted the FDA to issue a safety communication and also to recategorize its pregnancy category from Category C to Category D. Category C indicates the drug causes birth defects in animals. Category D indicates the drug has been shown to cause birth defects in humans.

Oral Cleft Development

During its growth, a fetus is at risk for developing oral clefts from the sixth to the eleventh week of pregnancy. The fetus' lips and palate before the sixth week are separated or cleft at the midline of the face.

During the following weeks, these facial features fuse together. Toxins such as Topamax® can interfere with completion of this development and the baby can be born with an cleft palate (the roof of the mouth), a cleft lip, or both.

Topamax® is prescribed to treat certain types of seizures in epileptic patients. The medication also is used to prevent migraines.

Contact a Topamax® Lawyer

If you were prescribed Topamax® for the treatment of seizures or migraine prevention and your baby is born with cleft lip or palate, you might be eligible for financial compensation through a Topamax® lawsuit. To find out if you qualify, contact a Topamax® lawyer today.