The U.S. Food & Drug Administration (FDA) has recently strengthened their initial warning on the drug Topamax (generic: topiramate). Previously, the Topamax medication was assigned to the Pregnancy Category C because of a lack of human data. However, they strengthened the warning to Category D as a direct result of new data that suggests Topamax may increase the risk of congenital birth defects in children like cleft lip, cleft palate, cranial malformations and other birth defects.
If you or a loved one took Topamax during pregnancy and your child was born with a birth defect, 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?
Topamax is intended for those who suffer from seizures and chronic migraine headaches. It is used as a preventative measure and will not stop any current bouts of seizures or migraines. However, the active ingredient in Topamax, topiramate, has been linked to an increased risk of congenital birth defects in children whose mothers were prescribed the drug during pregnancy.
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, genital malformations (hypospadias), and cranial defects.
Recent Topamax Studies
Data from the North American Antiepileptic Drug Pregnancy Registry showed the problem occurred in 1.4% of infants exposed to topiramate compared to a rate of 0.38% to 0.55% in newborns exposed to other antiepileptic drugs in utero.
For more information on the correlation between Topamax and congenital birth defects please visit The FDA’s website.
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 took Topamax during pregnancy and your child was born with a birth defect, 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.