Topamax is a very popular antiseizure medication prescribed around the country to treat epilepsy and migraine headaches. Topamax also goes by the generic name, Topiramate.
On March 4, 2011, the Food and Drug Administration issued an official Safety Alert about Topamax. The Safety Alert entitled “Topamax (topiramate): Label Change – Risk For Development of Cleft Lip and/or Cleft Palate In Newborns,” provided that the FDA had changed Topamax from a Category “C” to a Category “D” pregnancy drug. Category “D” pregnancy drugs have the potential to harm a developing fetus.
Prior to March of 2011, the Topamax package insert did not expressly mention cleft palate in newborns as a potential side effect the drug. The newly revised package language provides that “TOPAMAX use during pregnancy can cause cleft lip and/or cleft palate,” “[p]regnancy: increases risk of cleft lip and/or palate,” and “[d]ata from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft palate (oral clefts).” Additional information can be found in our entry entitled “Syracuse New York Topamax Birth Defect Lawyers Report Risk of Cleft Palate.”
If you took Topamax during pregnancy and your child was born with a cleft lip, cleft palate, or other serious birth defect including a penile abnormality known as a hypospadius, contact our legal team to learn whether you should file a Topamax birth defect lawsuit.