CaseyGerry is currently not accepting cases against Johnson & Johnson and related subsidiaries for their role in producing the dangerous drug Topamax (topiramate), which has been shown to greatly increase the risk of oral clefts (cleft lip and cleft palate) in the children born to women who have ingested Topamax during their 1st trimester of their pregnancy.
In their most recent safety communication, published March 2011, the U. S. Food and Drug Administration (FDA) warns of this newly discovered risk, and reports that they have reclassified Topamax from Pregnancy Class C to Pregnancy Class D. The FDA explains the reclassification by saying, “Pregnancy Category D means there is positive evidence of human fetal risk based on human data.”
Topamax is approved to prevent seizures and migraine headaches, as well as to treat Lennox-Gastaut syndrome in children and adults. However, Topamax was also used for a variety of off-label uses, including the treatment of psychiatric disorders, obesity, bulimia nervosa, drug and alcohol dependency and obsessive compulsive disorder. The subsidiary of Johnson & Johnson that is responsible for discovering/developing Topamax pled guilty in U.S. District Court to illegally marketing the drug for uses that were not approved by the FDA.
