A Pennsylvania mother blames Topamax for her son’s cleft palate and lip and claims Johnson & Johnson’s Janssen Pharmaceuticals negligently failed to inform patients about its risks until the FDA ordered stronger warnings in 2011.
In March 2011, the FDA said preliminary studies suggested Topamax might contribute to cleft lips and cleft palates in infants born to women who used the medication during pregnancy. The government asked the company to update the label enclosed with the medicine to reflect a stronger classification and warning for the drug.
The mother, April Czimmer, said she was prescribed Topamax from August 2006 through February 2007 to treat migraines. Her son was born in September 2007 with defects requiring four surgeries since birth, her lawyer said.
Lawyers for mothers who took the drug during pregnancy claim Janssen knew as early as 2002 that Topamax could raise the risk of birth defects, according to a master complaint filed in September 2011. Read the full story