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Topamax Cleft Palate

FDA Alert: Topamax® (topiramate) increases the risk of cleft palate in children born to mothers who took the drug during pregnancy. Patients and healthcare professionals are strongly advised to weigh risks vs. benefits before prescribing Topamax. Lawsuits are now being filed nationwide on behalf of victims of Topamax.

Topamax Birth Defects Update 7/19/12: A recently-published study, based on more than a decade’s worth of data, has confirmed prior research which identified a strong link between Ortho-McNeil’s controversial anti-convulsant Topamax (generic: topiramate) and oral cleft birth defects. This risk is greatest when expecting mothers take Topamax during their first trimester of pregnancy, a time when many women may still be unaware they are pregnant. Click here to learn more.

Free Topamax Cleft Palate Case Evaluation: If you or a loved one has given birth to a child with a congenital malformation after taking Topamax in pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

What’s the problem?

New research indicates that the use of the epilepsy drug Topamax may increase the risk of cleft palate, cleft lip and cranial malformations when it is taken by mothers during pregnancy. A recent study found an abnormally high number of children born with cleft lips and other birth defects among women using the drug in utero. The FDA said new data shows expecting mothers taking Topamax and its generic topiramate are about 20 times more likely to have newborns with cleft lip deformities than those who are not treated.

“Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of child-bearing age,” said Dr. Russell Katz, director of the FDA’s division of neurology products. “Alternative medications that have a lower risk of birth defects should be considered.”

Cleft Palate: An Overview

Cleft palate is a congenital (present at birth) defect that occurs when part of the lip doesn’t completely fuse together early in the first trimester of pregnancy, a time when many women don’t know they’re pregnant. Surgery is often performed soon after birth or in early childhood to close the lip. Signs and symptoms of cleft palate include (but are not limited to):

  • Change in nose shape (amount of distortion varies)
  • Failure to gain weight
  • Feeding problems
  • Flow of milk through nasal passages during feeding
  • Misaligned teeth
  • Poor growth
  • Recurrent ear infections
  • Separation of the lip alone
  • Separation of the palate
  • Separation of the lip and palate
  • Speech difficulties

Do I have a Topamax Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Topamax lawsuits. We are handling individual litigation nationwide and currently accepting new cleft palate cases in all 50 states.

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