What is Risperdal?
Risperdal is an anti-psychotic drug that was first approved by the FDA in 1993 to treat schizophrenia in adults.
The FDA later expanded approval of the drug to treat irritability in children and adolescents.
This was when the irritability was directly related to autism.
It has since also been approved to treat acute mania and bipolar disorders in younger patients.
Physicians have also commonly prescribed Risperdal off-label to treat other disorders among young patients.
These included attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD).
As more young patients began taking Risperdal, concerns began to grow about the drug’s potential side effects.
These can persist in some patients long after the drug is discontinued.
Johnson & Johnson and Janssen Pharmaceuticals are the defendants in more than 18,000 Risperdal lawsuits, many that have been filed by men and boys who allege that developed gynecomastia due to the use of the drug.
They also charge that although Risperdal was not approved for pediatric use until 2006.
About 20% of prescriptions for the medication were actually written for children because of the drug makers’ aggressive off-label marketing efforts.
In 2006, the Risperdal label was updated to warn that gynecomastia occurred in 2.3 percent of pediatric patients; before that is was listed as a rare side effect occurring in less than 1 in 1,000 patients.