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Topamax Maker Failed to Disclose Risk of Birth Defects

July 05, 2011

In yet another case of malfeasance by a greedy drug company, the makers of the drug Topamax failed to place warning information on the package about the possible side affects that their drugs could cause pregnant women, even though they were privy to the information.

The FDA has now required the makers of the epileptic drug Topamax and its generic version topiramate, to update their warning label to let users know that there are risks to using the drug while pregnant. The company apparently ignored information that has been around for years that side effects of the drug Topamax may cause birth defects and malformations. Cleft lip or cleft palate are two birth defects to which Topamax has been linked.

Back in July of 2008, a study was published in the medical journal called Neurology, which indicated that pregnant women who took Topamax to control their seizures were at a much higher risk of delivering babies with birth defects or malformations. The findings actually indicated that these women had a risk of their babies being born with cleft lip or palate that was 11 times greater of than that of women who did not take the drug. The risk of their babies being born with some kind of genital defect was 14 times higher than women who did not take Topamax.

Drug Makers Turn a Blind Eye

Even though the drug maker knew about the studies, they chose to ignore them and inform no one about the risks of taking their drug. It was not until they were compelled by the FDA a few months ago, that the drug maker updated the warning label for Topamax. The FDA has new data now that shows that babies born to mothers who had taken Topamax while pregnant were 20 times more likely to have an oral cleft problem.

What is Cleft Palate or Cleft Lip?

Cleft lip or cleft palate are defects from birth that are also known as oral clefts. The tissue on the roof of the mouth fails to join together, and this split, or cleft, forms a gap in the soft palate of the mouth or can form a hole in both the soft and hard palate that goes up to the nasal cavity. This kind of deformity can impact how a baby eats, breathes and speaks.

Repairing a cleft palate normally requires multiple surgeries with the first one being performed when a child is only 9-18 months old. Orthodontic care is often needed as well. Therapy for speech, growth, hearing, dental and mental development also may be necessary.


Most women who take Topamax are doing so to treat their epileptic seizures or to prevent migraine headaches. If a woman learns she is pregnant, she should contact her doctor immediately. An expectant mother should discuss the situation with her physician because problems can result if a woman suddenly stops taking the drug. There is also a danger when treatment of the epilepsy is stopped.

If you or a loved one have had a child born with cleft palate or other congenital malformations, and they were exposed to Topamax before they were born, you may be eligible for compensation through a Topamax lawsuit. If you believe your child has suffered serious injuries involving the use of the drug Topamax, we offer a free case evaluation. Montlick and Associates, Attorneys at Law, consistently strives to offer excellent quality legal representation with a focus on providing exceptional service as part of our ongoing goal of being the premier personal injury law firm in Atlanta and throughout Georgia.

Our Topamax side effects attorney are available to discuss your case.  We assist clients throughout all of Georgia and the Southeast, including but not limited to Albany, Athens, Atlanta, Augusta, Columbus, Gainesville, Macon, Marietta, Rome, Roswell, Savannah, Smyrna, Valdosta, Warner Robins and all smaller cities and rural areas in the state. No matter where you are located our attorneys are just a phone call away, and we will even come to you. Call us 24 hours a day/7 days a week for your Free Consultation at 1-800-LAW-NEED (1-800-529-6333). You can also visit us online at and use our Free Case Evaluation Form or 24-hour Live Online Chat
Category: Personal Injury

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All information provided by our blogs is general in nature and should not be relied upon as legal advice. Consult a Montlick attorney for details about your unique situation.