February 12, 2015 — A lawsuit has been filed by a man who was prescribed Risperdal as a child and developed gynecomastia (enlarged breasts).
The lawsuit was filed against Johnson & Johnson in Jefferson County, Texas, according to the Southeast Texas Record.
The plaintiff was prescribed Risperdal when he was just seven years old. The prescription was “off-label” (not FDA-approved) for the treatment of attention-deficit hyperactivity disorder (ADHD).
At the time, Risperdal was not approved for any uses in children. It was only approved for adults with schizophrenia. The FDA has never approved Risperdal for ADHD, although in 2006 it was approved for the treatment of irritability associated with certain intellectual disabilities in children aged 5-16 years.
According to the complaint, Moore developed long-lasting emotional problems due to gynecomastia. The lawsuit accuses the manufacturer of Risperdal, Janssen Pharmaceuticals and Johnson & Johnson, of failing to adequately warn about the side effects of Risperdal in children.
In November 2013, the drug-makers agreed to pay the Justice Department $2.2 billion for illegally marketing several drugs. The settlement also resolved allegations of marketing Risperdal “off-label” in children with ADHD.
According to prosecutors who announced the settlement:
“Janssen instructed its sales representatives to call on child psychiatrists, as well as mental health facilities that primarily treated children, and to market Risperdal as safe and effective for symptoms of various childhood disorders, such as attention deficit hyperactivity disorder.”
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