The U.S. Food & Drug Administration (FDA) has recently strengthened their initial warning on the anticonvulsant drug Topamax. The strengthened warning is a direct result of new data that suggests Topamax may increase the risk of congenital birth defects in children like cleft lip and/or palate, and other birth defects.
If you or a loved one has given birth to a child with cleft lip and/or palate after taking Topamax, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
What’s the problem?
In the past, the FDA had originally designated Topamax as a Pregnancy Category C because of the lack of human data. However, recent data suggests the category be elevated to D because mothers who have been prescribed Topamax while pregnant may increase the risk of their child developing severe congenital birth defects including:
- Cleft lip: (Cheiloschisis) A separation of the two sides of the lip, usually involving the bones of the upper jaw, upper gum, or both.
- Cleft palate: (Palatoschisis) An opening in the roof of the mouth in which the two sides of the palate did not fuse together properly.
- Genital Malformations (hypospadias)
- Other birth defects
Causes of Cleft Lip and/or Palate
Researchers believe that the majority of cleft lip and cleft palate cases are directly correlated to the interaction of genetic and environmental factors. However, the specific cause is unknown. A 2008 study published in the journal Neurology found that children born to mothers who took Topamax while pregnant may be at a greater risk of developing serious congenital birth defects like cleft lip and/or palate, genital malformations (hypospadias), cranial defects, and other birth defects.
Do I have a Topamax Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Topamax lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by Topamax, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.