Topamax | Topiramate Birth Defects

On March 4, 2011, the Federal Drug Administration (FDA) issued a Safety Advisory Alert for infants born with birth defects including Cleft Palate and Cleft lip when the pregnant mother was using Topamax or Topiramate during pregnancy.

The FDA warning concluded that data collected from a national pregnant women registry has shown a dramatic increase in babies being born with cleft lip and cleft palate when their pregnant mothers used Topamax or Topiramate during the pregnancy. The alert stated that "health care professionals should carefully consider the benefits and risks of Topamax and Topiramate when prescribing it to women of childbearing age." The FDA raised the drug's pregnancy category to D, which means there is evidence the drug can harm the fetus or infant. Topamax is marketed by Johnson & Johnson to control seizures caused by Epilepsy and Migraine headaches. It has been prescribed to approximately 4.3 million patients between 2007 and 2010.

Johnson & Johnson and certain generic companies which market the drug under the name Topiramate are now required to add a stronger warning label concerning the drug's infant related side effects.

The birth defects we are investigating are Cleft Palate, Cleft Lip and other genital defects.

Remember, Topamax is widely prescribed for migraine headaches. Women are three times more likely to suffer from migraines than men.
Unfortunately, younger women are even more susceptible to migraine headaches. More women of childbearing age are using the drug for migraines than epilepsy.

The condition known as oral cleft happens when a part of the mouth does not completely fuse together, which leads to the infant's difficulties in eating and talking. The defect is resolved by surgery that closes the lip or palate.

The FDA safety alert is quoted below:
"We are investigating Topamax birth defect side effect cases nationwide and throughout your state".
Click Here to Read Full FDA Warning / Safety Advisory Alert

Please contact us so we can advise you if you have a potential case. We will provide you with a free confidential consultation to advise you of your legal rights. Please either call us at 1-800-718-4658 to speak with an intake specialist or complete the email inquiry on the right.

Latest News

September, 2011

As Topamax side effect cleft palate birth injury lawyers we continue to update the public with Topamax birth injury side effect news. Topamax, the Johnson & Johnson Ortho-McNeil anti seizure medication known as an anti convulsant, marketed under both Topamax brand and the generic Topiramate, has been linked to an increase birth defects to infants.

Topamax, in addition to being prescribed for migraines and epilepsy is also being prescribed for psychiatric purposes including borderline personality, manic aggressive behavior, for alcoholics, for cigarette addiction, morbid obesity, bulimia and anorexia, etc.

April, 2011

Ortho-McNeil recalled over 55,000 Topamax containers due to foul odors emanating from the containers.

To date, Johnson & Johnson has been fined by the federal government on multiple occasions for marketing Topamax for non-approved psychiatric purposes. They have paid fines of well over $75,000,00 thus far.

March, 2011

The FDA published a Safety Notice Alert notification concerning the increased risk of birth defects specifically oral clefts in infants whose mothers used Topamax during pregnancy. The FDA indicated that pregnant women using Topamax were more likely to have their children born with a cleft lip or cleft palate birth defect.

A study released by the North American Anti Epileptic Drug Pregnancy Registry concluded that there is a 21% greater chance of cleft palette from a Topamax or Topiramate exposed pregnancy than not. A United Kingdom pregnancy study concluded there is a 16 times increase in birth defects to infants exposed to Topamax during pregnancy.

Because of these new studies the FDA changed the Topamax pregnancy category to a D which means there is positive evidence of human fetal (baby) risk due to Topamax.

Cleft palette is a gap in the body which causes a non complete sealing of the bony structure during fetal development. Clefts often occur on the lip and roof of the mouth and are called cleft lip / palette or isolated cleft palette. If a cleft palette occurs without cleft lip it is called an isolated cleft palette. These are separate birth defects. The problem with these defects are not only cosmetic but it prevents the baby from sucking and can make the baby more prone to infections. Certain infections of the ear can cause permanent hearing loss. We have seen many children have tubes in their ears to drain out the infected fluids.

Most children with cleft lips or cleft palettes have surgery to correct the problem. Surgery is often done between the ages of six and twelve weeks. There is further future care including audiologists, speech therapists, occupational therapists, ENT doctors, pediatric dentists, etc.

We plan to file Topamax side effect lawsuits in Philadelphia, where a Topamax mass tort program has been created by the courts, New Jersey because Ortho-McNeil’s headquarters is in Titusville, New Jersey and in California.

If you or your loved one suffered a Topamax related birth injury please contact one of our Topamax specialists at 1-800-718-4658. We are actively pursuing Topamax side effect claims throughout California through our 18 offices and in all 50 states.

There is no charge for our services until there is a recovery from the manufacturer.

Attorney Advertising – Trademark Notice: the use of the term Topomax® is strictly for identification purposes and Attorney Advertising.  Topomax® is a registered trademark of Ortho-McNeil-Janssen Pharmaceuticals, Inc.  Nadrich & Cohen LLP is in no way affiliated with Ortho-McNeil-Janssen Pharmaceuticals, Inc.