Janssen’s Topamax Users blame Drug for Birth Defects
” Johnson & Johnson’s (JNJ) Janssen Pharmaceuticals failed to inform expectant mothers of risks that its epilepsy drug Topamax could cause birth defects, a lawyer for the mother of a Virginia 6-year-old told a jury. April Czimmer wouldn’t have taken Topamax for more than six months had she known the risks associated with the drug, her attorney Tommy Fibich said in opening statements today in state court in Philadelphia. Czimmer blames the drug for her son’s cleft palate and lip and claims Janssen negligently failed to inform patients about its risks until the U.S. Food and Drug Administration ordered stronger warnings in 2011. ”
Elevated risk for cleft lip and cleft palate in babies born to women who took topiramate during pregnancy
The FDA has issued several warnings about the use of topiramate by childbearing woman based on data from two registries, which showed an increased risk of oral clefts in infants exposed to monotherapy during the first trimester of pregnancy.
The FDA said topiramate would now be classified as a “Pregnancy Category D” drug, meaning there is evidence of human fetal risk based on human data.