If you took Topamax® while you were pregnant and your baby was born with a cleft lip or a cleft palate, you may have grounds for a lawsuit against Ortho-McNeil Neurologics, the drug manufacturer.

To find out if you qualify top file a Topamax® lawsuit, contact an experienced Topamax® lawyer at AWKO law by calling (888) 255-AWKO (2956).

Background Information

Studies reviewed by the U.S. Food and Drug Administration (FDA) show that Topamax® increases the risk of cleft lip and/or cleft palate in babies whose mothers take the drug early in their pregnancies.

The formation of the lips and palate in the fetus takes place from the sixth to the eleventh week of the mother's pregnancy. During this time, the lips and palate, which previously were separated at the midline of the face, fuse.

If something such as a teratogenic (interfering with fetal development) drug alters that development, the baby may be born with a gap in the middle of the lips or the roof of the mouth.

Data Shows a Topamax® Birth Defect Risk

According to study results, the percentage of babies born with oral clefts was 1.4 percent in infants born to mothers taking Topamax®; 0.38 to 0.55 percent in infants born to mothers taking another anti-seizure medication; and 0.07 percent in infants born to mothers who were not epileptic and did not take antiseizure medication.

Statistics in the United Kingdom support the U.S. findings. The UK Epilepsy and Pregnancy Register also showed that Topamax® caused oral clefts. According to its data, the registry showed there was a 3.2 percent risk of babies being born with oral clefts if their mothers took Topamax® during the first trimester of her pregnancy. This risk was 16 times more than the general population.

Because of these numbers, the FDA changed the pregnancy category of Topamax® from Category C to Category D. Category C means a drug has been found to cause birth defects in animals, but not enough data are available to say it causes birth defects in humans. Category D means a drug does cause birth defects in humans.

Topamax® was approved by the FDA in 1996 and is manufactured by Ortho-McNeil Neurologics. It is indicated for treating patients with certain types of epileptic seizures. It is sometimes prescribed for migraine prevent.

Who Qualifies to File a Topamax® Lawsuit?

If your baby is born with cleft lip or cleft palate and you took Topamax® while pregnant, there is a good chance you will qualify to file a Topamax® lawsuit, especially if you were unaware of the dangers.

A lawsuit can help you seek compensation to ensure your baby receives the highest quality in medical treatment and care. Cleft lip and palate can usually be fixed through one or more surgeries. Most babies will achieve normal speech, eating and appearance, though it can take years. A lawsuit can help ease the stress of what can be an emotional recovery process.

Call 1-888-255-AWKO (2956) to schedule an evaluation with an experienced Topamax® attorney.