Risperdal (risperidone) is an FDA-approved antipsychotic medication for the treatment of schizophrenia as well as the short-term treatment of episodes and acute mania related to bipolar disorder. It was approved by the FDA for treatment of schizophrenia in 2002, followed by approval in 2003 for bipolar 1 disorder. In 2006, the FDA approved Risperdal for the symptomatic treatment of behavioral issues, including irritability, in autistic children and adolescents.

Risperidone was first developed by the Johnson & Johnson subsidiary Janssen-Cilag between 1988 and 1992 and was first approved by the FDA in 1994. It is characterized as a dopamine antagonist comprised of anti-adrenergic, anti-histaminergic, and anti-serotonergic properties. Risperidone is listed on the World Health Organization’s List of Essential Medicines.

Risperdal has a history of being prescribed for off-label conditions, lacking the necessary testing and approval to serve as a safe course of treatment. Its use has been applied to children with attention deficit disorder (ADD) as well as depression and anxiety, and to adults with dementia and similar behavior disorders.

Beginning in 2002, the drug began being openly marketed for these purposes. In 2006, the Journal of Clinical Psychopharmacology published a study linking risperidone to gynecomastia, or the development of breasts in young males. The study further asserted that prescriptions of the drug for children should be handed out cautiously, as the long-term effects of the medication were not well-known with regard to growth and puberty.

Despite being warned by the FDA about misleading messages, the pharmaceutical company — now known as Janssen Pharmaceuticals Inc. (JPI) — continued these tactics. While it has been observed to be effective in treating a variety of medical conditions, it has been linked to both serious and life-threatening side effects. The FDA Office of Criminal Investigations eventually launched an investigation into the company’s conduct.

In September 2012, a lawsuit was settled with a 21-year-old male who developed gynecomastia upon being treated with Risperdal from ages 9 to 14. This abnormal development led to long-term psychological trauma; the settlement amount was undisclosed.

On Nov. 4, 2013, Janssen Pharmaceuticals Inc. pled guilty to allegations of introducing Risperdal into interstate commerce as a misbranded drug. The company’s fine, more than $1.67 billion, included a $400 million criminal fine in addition to a civil settlement agreement. The company was also ordered to pay $1.25 billion in a separate civil settlement. At a total of more than $2.2 billion, this financial penalty represented one of the largest ever issued to a company for health care fraud.