Risperdal is an atypical antipsychotic. It is a brand name of the drug risperidone, which doctors may prescribe for the treatment of schizophrenia, bipolar mania, and autism.
In 1993, the Food and Drug Administration (FDA) approved the use of Risperdal for the treatment of schizophrenia in adults. The federal agency later approved the drug for the treatment of bipolar disorder in adults. Not until 2006 was approval expanded to include pediatric treatment for any disorder. However, even before the drug was approved for use in children, the company allegedly began promoting it for the control of schizophrenia, bipolar disorder and other mental disorders in children. Sales representatives were allegedly pushed to promote the drug to doctors as far back as 2003.
Risperdal is manufactured by Janssen Pharmaceuticals Inc., a Johnson & Johnson company. In November 2013, the FDA announced that the company agreed to pay more than $1.6 billion to resolve allegations that it introduced a misbranded product into the market.
The company faces several Risperdal lawsuits, and in 2012, settled its first lawsuit. Many of these lawsuits allege that unapproved use of Risperdal caused gynecomastia in young males.
What is gynecomastia?
One of the most prominent side effects linked to pediatric Risperdal use is gynecomastia. This is a condition in which there is an enlargement of male breast tissue in adolescents and young men. As a result, the breasts grow and become tender and painful to the touch. This condition, although not life-threatening, is traumatic and very embarrassing.
Risperdal Side Effects
Apart from gynecomastia, Risperdal may cause other side effects, including:
- trouble concentrating or with memory;
- unable to move eyes;
- problems urinating;
- difficulty sleeping;
- trouble speaking and swallowing;
- trembling; and
- back or chest pain.
These are just a few possible Risperdal side effects. If you notice any of these or other side effects, see your doctor immediately.
Can I file a Risperdal lawsuit?
The FDA alleges that Janssen Pharmaceuticals Inc. continued to promote the use of Risperdal in children who suffer from behavior problems, in spite of the fact that that there were known health risks to these children. The federal agency also alleges that the company began promoting the use of the drug for the treatment of dementia in the elderly as far back as March 2002, even when it was not approved for this population.
Any person who used Risperdal for unapproved uses when the drug was not approved for their population while the manufacturer promoted it for such use and suffered injuries as a result should speak with an attorney about options for compensation.
If you suffered side effects like gynecomastia because of Risperdal use, speak with attorney Julie Johnson about your rights to file a Risperdal or risperidone lawsuit. Call the Law Office of Julie Johnson at 214-290-8001 or contact us online to set up a consultation about your case.