RISPERDAL & INVEGA

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 and Invega

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.

How Do They Work

Risperdal can be taken orally as a tablet, and is also available as an injection. The injectable version of Risperdal is sold under the brand name Risperdal Consta. Invega is available in extended-release tablets. In 2009, the injectable once-a-month version of Invega, Invega Sustenna, was approved. The exact mechanisms of how these drugs work are unknown, but they are intended to reduce symptoms by influencing the levels of serotonin and dopamine in the brain. Risperdal and Invega are often prescribed independently of each other, but they can also be prescribed in combination with other medications, depending on the patient’s condition. These medications are sometimes combined with lithium or an antidepressant to treat bipolar disorder or depression, respectively.

Invega and Risperdal have the same basic function, but are processed by the body differently. When Risperdal is broken down by the liver, it releases metabolites. The most crucial metabolite of Risperdal is Invega. Both medications work to reduce psychosis and aggressive behavior in patients with schizophrenia, although Risperdal is approved for other conditions as well.

Risperdal and Off-Label Use in ADHD Patients

Risperdal is frequently used off-label to mitigate behavioral issues associated with Attention Deficit Hyperactivity Disorder (ADHD). Using this powerful antipsychotic drug in children has raised a number of safety concerns. Among other things, Risperdal use in children has been linked to gynecomastia, or abnormal breast growth in males.

According to a study published August 2014 in the Archives of General Psychiatry, use of Risperdal and other antipsychotics for ADHD in pediatric patients increased significantly between 1999 and 2009. Researchers indicated that there is not a substantial amount of evidence to suggest that antipsychotics would benefit children with ADHD. Furthermore, they pointed out that little is known about how these drugs impact a developing brain. Risperdal was the most common antipsychotic prescribed to children and adolescents with ADHD in the study.

In November 2013, J&J and Janssen agreed to pay $2.2 billion to resolve criminal and civil investigations involving Risperdal, Invega and the heart failure drug Natrecor. Among other things, the federal government alleged that the company marketed Risperdal off-label in children with ADHD, oppositional defiant disorder, obsessive-compulsive disorder and autism from 1999 to 2005. During this time, the drug was not approved for use in children for any reason. The government alleged that Janssen ignored repeated warnings by the FDA and continued to market it as safe and effective in children and adolescents.

What are the Side Effects Associated with Risperdal and Invega?

All medications carry a risk of side effects, but some are more serious than others. Furthermore, manufacturers have a responsibility to warn of the risks so the physician can make the most informed decision about the patient’s health. A number of lawsuits have alleged that Janssen and J&J failed to warn about the risk of adverse events. Side effects potentially linked to Risperdal and Invega include:

  • Gynecomastia
  • Movement disorders (tardive dyskinesia, tardive dystonia, parkinsonism)
  • Diabetes
  • Cardiovascular problems

Risperdal and Invega Lawsuits

Johnson & Johnson and Janssen Pharmaceuticals have been involved in a substantial amount of litigation over Risperdal and Invega. The drug makers have settled a number of state and federal lawsuits alleging that they marketed the drugs for off-label uses. In fact, 36 states’ attorneys general and the District of Columbia alleged that the companies illegally promoted Invega and Risperdal for unapproved uses between 1998 and 2004. The separately filed state lawsuits alleged, among other things, that J&J marketed Risperdal off-label for children as well as patients with Alzheimer’s disease, dementia, depression and anxiety. In August 2012, J&J agreed to pay $181 million to resolve these allegations.

Another settlement was reached in November 2013, when the companies agreed to pay $2.2 billion to resolve allegations over Risperdal, Invega and Natrecor. Janssen pled guilty to marketing Risperdal off-label in elderly patients with dementia and, as a result, agreed to pay a criminal fine of $334 million and a forfeiture of $66 million, according to a Department of Justice press release. The government had also alleged that Janssen marketed Invega for unapproved uses between 2006 and 2009, and made false and misleading statements about its safety and efficacy.

J&J is also facing a number of lawsuits alleging that the off-label use of Risperdal had caused gynecomastia. Some of these cases were filed on behalf of patients who were prescribed Risperdal for ADHD.