What is Topamax?
Topamax (topiramate) is an anticonvulsant that works by decreasing abnormal excitement in the brain. Used to treat certain types of seizures in individuals who have epilepsy, Topamax is also used with other drugs to control seizures in patients who have Lennox-Gastaut syndrome (a disorder that causes seizures and developmental delays).
On March 4, 2011, the U.S. Food and Drug Administration (FDA) released information from numerous studies that found a significant increase in Topamax birth defects, including the risk of craniofacial defects among infants exposed to Topamax’s active ingredient, topiramate. As a result, the FDA reclassified Topamax as a Pregnancy Category D medication, which means there is potential to cause significant harm to a human fetus, with benefits outweighing the risks only in certain situations.
Topamax Birth Defects
Fetal exposure to Topamax increases the risk of being born with a cleft lip or cleft palate. Cleft lip and cleft palate are recognized as craniofacial birth defects. They occur when portions of the upper lip or palate do not completely fuse together during the first trimester.
Cleft lip appears as an opening in the upper lip, and extends upward toward the nasal area. Cleft palate is an opening in the roof of the mouth that extends upward into the nasal passages. Cleft lip and palate may cause additional health complications including difficulty feeding and raised likelihood for ear disease, speech disorders and socialization complexes.
A Topamax lawsuit holds the pharmaceutical manufacturer responsible for manufacturing defects, design defects, and inadequate warning labels. Manufacturing and design defect claims are similar in that they aim to prove that Topamax is defective in its manufacturing or design”such that it is unreasonably dangerous and not fit for the ordinary purposes for which it was intended. An œinadequate warning label claim’s goal would be to prove that the Topamax side effect warnings were insufficient, especially for pregnant women.
A Topamax lawyer can assist you with a Topamax lawsuit if you or a loved one has given birth to a child suffering from a Topamax birth defect. Contact a Chaffin Luhana Topamax lawyer today at 1-888-480-1123 for a free and confidential case review. You may be entitled to compensation and a Topamax lawyer can help you fight for your rights.