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    Topamax Lawyer Justinian Lane Discusses Cleft Lips

    In early March of 2011, the FDA strengthened the warning label on Topamax (generic name: Topiramate) due to an association between Topamax use and birth defects.  Currently, Topamax is most strongly associated with oral birth defects, such as cleft lips and cleft palates. 

    Cleft lips are fairly common birth defects in which the upper lip is split.  A cleft lip occurs when the facial structures in a fetus do not fully close.  A cleft lip can occur on one or both sides of the face, and can range in size and severity.

    Researchers do not yet understand exactly what causes a cleft lip to occur.  However, studies have shown that Topamax increases the risk of a cleft lip.  Topamax lawyers are interested in this scientific research as it will be critical to win a Topamax lawsuit.

    It wasn't until I began researching Topamax birth defects that I learned how serious of a medical condition that a cleft lip is.  I initially thought a cleft lip was a cosmetic issue only.  It isn't.  In fact, a cleft lip can lead to hearing loss, eating and speaking difficulties, and numerous psychological challenges. 

    If you or a loved one took Topamax during a pregnancy and gave birth to a child with a cleft lip, feel free to e-mail me at  I'm currently reviewing Topamax birth defect cases and will be happy to discuss your potential case with you.


    Will the first Topamax lawsuit be filed this week?

    Topamax lawyers are heavily advertising on the Internet regarding the link between Topamax and birth defects like cleft palates and cleft lips.  To the best of my knowledge, no Topamax attorney has yet filed a Topamax birth defect lawsuit. 

    One of the reasons why I suspect that Topamax litigation will commence so soon after Topamax was linked to birth defects is because of the rules of Multi-District Litigation.  (MDL)  Whenever a large number of drug lawsuits are filed across the country, they are eventually consolidated into an MDL.  That simply means that instead of all of the Topamax lawsuits being filed across the country, they're initially filed in one court, so the same judge can make sure everything proceeds in an orderly fashion.  (Many people confuse class action lawsuits with MDL proceedings.  By and large, if the lawsuit involves a large number of people hurt by a drug like Topamax, it will be an MDL.  However, there may also be a Topamax class action.  If an when that happens, I'll post about it here.)

    When an MDL is created, the MDL judge appoints a steering committee.  The steering committee will consist of Topamax attorneys who (a) have a great deal of experience in drug litigation, and (b) have a large number of Topamax lawsuits of their own.  The first lawyer to file a Topamax lawsuit will be at an advantage when it comes to applying for a position on the Topamax steering committee.

    I therefore suspect that someone will work to get a Topamax lawsuit filed this week.  I could be wrong, but I'd be very surprised if the first Topamax case isn't filed this month.

    If you'd like to know more about how an MDL works, or whether you're eligible to bring a Topamax lawsuit on behalf of your child, feel free to e-mail me using the contact form.


    Topamax Linked To Birth Defects

    On March 4th of 2010, the FDA announced that new data showed that women who take Topamax during pregnancy are at an increased risk of giving birth to a child with a cleft lip or a cleft palate.  Topamax and Topiramate (the generic equivalent of Topamax) were approved by the FDA to treat certain types of epileptic seizures.  Eventually, they received FDA approval to prevent migraine headaches.

    The FDA classifies drugs according to whether or not they pose a risk of causing birth defects.  Topamax was initially in Category C, meaning that studies showed a risk of birth defects in animals, but there was insufficient evidence in humans.  The FDA has now moved Topamax to Category D, which means there is positive evidence of risk of birth defects in humans.

    Here is what the FDA currently recommends regarding Topamax during pregnancy:

    Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional. Women taking topiramate should tell their health care professional immediately if they are planning to or become pregnant. Patients taking topiramate should not stop taking it unless told to do so by their health care professional. Women who become pregnant while taking topiramate should talk to their health care professional about registering with the North American Antiepileptic Drug Pregnancy Registry, a group that collects information about outcomes in infants born to women treated with antiepileptic drugs during pregnancy.

    If you took Topamax or Topiramate during your pregnancy and gave birth to a child with a cleft palate, a cleft lip, or other skeletal deformity, Topamax may be to blame.  As a Topamax attorney, I'd be happy to talk with you about your child and what legal options you and your child may have.


    FDA Took Years To Process Topamax Birth Defect Data

    It wasn't until March of 2011 that the FDA issued a warning that linked Topamax with cleft palate and cleft lip birth defects.  But back in July of 2008, a study linked the drug to those very defects:

    For the study, researchers examined women who became pregnant while taking topiramate either on its own or along with other epilepsy drugs. Of 178 babies born, 16 had major birth defects. Three of these were in infants whose mothers were taking only topiramate, and 13 were in those whose mothers were taking topiramate and other epilepsy drugs.

    Four of the babies had cleft palates or cleft lips, a rate 11 times higher than that expected if these women were not taking epilepsy drugs. Four male babies had genital birth defects, with two of those classified as major defects, which is 14 times higher than the normal rate for this defect.

    Source: Epilepsy Drug May Increase Risk of Birth Defects

    It's unfortunate that our regulatory system can take years to recognize the risks that drugs cause to unborn children.  At least the risk is recognized now, and hopefully there will not be as many women who take Topamax while pregnant.