Risperdal and Invega are atypical antipsychotic medications. Also known as second generation antipsychotics, atypical antipsychotics target both dopamine and serotonin receptors, although they are more specific to dopamine, to treat certain mental illnesses. Risperdal was approved by the U.S. Food and Drug Administration (FDA) in 1993. It is used to treat schizophrenia, symptoms of bipolar I disorder and behavioral symptoms in children with autism. Invega, approved in 2006, is only approved to treat schizophrenia in patients who are at least 12 years old. However, these drugs have also been used to treat a number of unapproved conditions as well.
These medications have been used for several unapproved or “off-label” purposes including attention deficit hyperactivity disorder (ADHD), anxiety, difficulty sleeping, depression, and behavioral symptoms in patients with dementia. Off-label uses can prompt a number of safety concerns in certain situations. Doctors are able to prescribe drugs off-label if they determine that it is appropriate. Pharmaceutical companies, however, are prohibited from marketing their drugs for purposes not approved by the FDA. Off-label uses for Risperdal and Invega have led to substantial litigation, including charges filed by the government. In fact, manufacturer Johnson & Johnson (“J&J”) and its subsidiary Janssen, have settled allegations on more than one occasion and pled guilty to misbranding Risperdal; the company has also paid a criminal fine.