Topiramate (Generic Topamax) Information
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Topiramate is a generic anti-epilepsy medication better known as the brand name drug Topamax®. In March 2011 the FDA issued a warning that the drug was responsible for causing major birth defects. Previous topiramate drug information had warned of possible risks to the fetus, but it has now been confirmed. When taken during the first few weeks of a pregnancy, the baby has a greatly increased risk of developing cleft lip or palate.
If you were prescribed Topamax®, or used a generic version of topiramate, and became pregnant, you were likely unaware of the risks to your baby. Oral clefts, while often treatable with surgeries, can cause life-long physical and emotional problems in children. Contact a Topiramate lawyer today to learn about lawsuits used to hold the manufactures of birth defect drugs accountable for their products.
Topiramate Warning
The FDA previously classified topiramate as a Category C drug, meaning animal studies had shown potential risk to the fetus, but there were no studies on humans. Now that a human study has shown significant risk to the fetus, the drug information has been updated to re-classify topiramate as category D. These drugs have been proven to cause birth defects, but the benefits for some users may outweigh the risks.
The new drug information shows that topiramate users are 20 times more likely to give birth to a baby with an oral cleft than women who were not taking any epileptic drugs. Topiramate (Topamax®) is also 4 times as likely to cause oral clefts than other epilepsy drugs.
Topiramate Birth Defects
Oral clefts are gaps in the structures of the face, including the lips and the palate, which is the roof of the mouth. These structures come together early in a pregnancy and fuse together. The drug information for topiramate shows that it can disrupt that process. The gaps forming oral clefts can vary in seriousness, with some cleft lips extending all the way to the nose.
Contact a Topamax® Cleft Lip Lawyer
If your baby was born with a cleft lip or a cleft palate caused by Topamax® or a generic version, you should speak to one of our birth defect attorneys. A qualified lawyer will evaluate your circumstances in a free consultation to determine if you have a legitimate claim.
