Known generically as topiramate, Topamax is an anti-seizure drug manufactured by Ortho-McNeil-Janssen Pharmaceuticals, a unit of Johnson & Johnson now known as Janssen Pharmaceuticals. Topamax was approved by the U.S. Food and Drug Administration (FDA) in 1996 for the treatment of seizures and migraines.
In March 2011, the FDA released updated safety information for Topamax relating to the risk of birth defects that the drug poses to unborn children. The FDA warning concentrated on Topamax and oral defects, specifically cleft lips and cleft palates. In the data reviewed by the FDA, which was provided by the North American Antiepileptic Drug Pregnancy Registry, they recorded a higher incidence of cleft lips and cleft palates, in comparison to other kinds of birth defects, among children exposed to Topamax in the womb.
Furthermore, the FDA also recorded a lower birth weight among those children born to mothers who used Topamax during pregnancy.
As a result of the human evidence linking Topamax use during pregnancy to birth defects, the FDA categorized Topamax as a Pregnancy Category D drug.
When exposed to Topamax in the womb, there is strong evidence that the anti-seizure drug causes birth defects in children, especially oral defects. These oral defects include cleft lips and cleft palates. Both of these defects are facial deformities wherein proper structural fusion fails to occur.
A cleft lip is a gap in the lip that may extend into the nose. If that gap extends beyond the nose and onto the roof of the mouth, the structural deformity is known as a cleft palate. A cleft palate can also form on the roof of the mouth without extending to the nose and lips, a condition known as an incomplete cleft palate.
Carey Danis & Lowe is a national law firm based in St. Louis that represents victims of defective drugs, including Topamax. If your child was born with congenital birth defects, such as a cleft lip or a cleft palate, after being exposed to Topamax in the womb, Carey Danis & Lowe is available to assist you in seeking legal recourse.
Discuss your case and legal options with a Carey Danis & Lowe Topamax birth defects lawyer. Our initial consultations are free.
Carey Danis & Lowe Topamax lawyers are highly experienced in handling personal injury claims and pharmaceutical litigation involving defective drugs. We work closely alongside our on-staff team of medical experts and our clients to develop strong cases.
For more information about Topamax and oral defects, and for assistance with filing a Topamax lawsuit, contact Carey Danis & Lowe by phone at 800.721.2519, or by completing a confidential personal injury claim.