These drugs are known as atypical antipsychotics because they target both dopamine and serotonin receptors in the brain.

Risperdal Lawsuits

Risperdal and Invega are two atypical antipsychotic (also known as second-generation antipsychotic) medications. These drugs are known as atypical antipsychotics because they target both dopamine and serotonin receptors in the brain. The U.S. Food and Drug Administration (FDA) approved Risperdal in 1993 to treat schizophrenia. It is also approved to treat symptoms of bipolar I disorder and autism. Invega was approved in 2006 and is only indicated for patients with schizophrenia who are 12 years or older. While these drugs have their approved uses, they are also frequently used off-label.

Risperdal is sold both orally as a tablet and also in injectable form. 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. Invega and Risperdal essentially do the same thing but are broken down by the body differently. Invega is a metabolite of Risperdal.

There have been substantial safety concerns and litigation involving Risperdal and Invega. Patients have alleged that Johnson & Johnson (J&J) and subsidiary Janssen failed to warn or hid the risks of serious side effect. The drugs have been linked to gynecomastia (male breast growth), movement disorders, diabetes and heart problems. The government has also taken legal action against the manufacturers alleging that they misrepresented the drug and illegally promoted it to children and elderly patients with dementia. In fact, Janssen has pled guilty to misbranding Risperdal and agreed to pay a criminal fine.

Safety Concerns and Side Effects

Risperdal and Invega have raised a number of safety concerns, especially those related to off-label use. Although doctors are allowed to prescribe drugs off-label at their own discretion, it is illegal for pharmaceutical companies to market their drugs for uses not approved by the FDA.

In 2005, a black box warning was added to Risperdal warning that the drug was linked to an increased risk of death in dementia patients. A black box warning, also known as a boxed warning, is the strongest warning required by the FDA. When a drug carries a boxed warning, it means that studies show that it has a risk of serious or life-threatening side effects. The warning was added following an FDA analysis of 17 placebo-controlled trials consisting of 5,106. The rate of death in placebo group was about 2.6 percent, compared to 4.5 percent in patients treated with antipsychotics. The FDA noted that most deaths were caused by cardiovascular issues (such as heart failure or sudden death) and infectious diseases (such as pneumonia), although the causes varied.

Risperdal and Invega are linked to gynecomastia, or the growth of abnormal breast tissue in males. The drugs are believed to trigger this effect because dopamine regulates levels of prolactin, the hormone responsible for milk production. There are a number of lawsuits filed on behalf of patients who developed gynecomastia, allegedly due to the antipsychotics. There were over 130 lawsuits involving Risperdal/Invega and gynecomastia as of September 2012.

Risperdal and Invega may also trigger metabolic changes that increase the risk of heart disease, including hyperglycemia, dyslipidemia, weight gain and diabetes. This risk of diabetes associated with antipsychotics is compounded by the fact that patients with schizophrenia are already at an increased risk of type 2 diabetes.

These powerful antipsychotics can also cause movement disorders, including tardive dyskinesia, tardive dystonia and parkinsonism. These conditions lead to involuntary bodily movements, which can range from short, quick motions to slow, painful twisting ones.

Off-Label Marketing, Misrepresentation

J&J and its subsidiary Janssen have been accused of marketing Risperdal and/or Invega for unapproved uses numerous times and for misrepresenting the safety of these drugs. In fact, the government has alleged that the company advertised these drugs off-label, paid illegal kickbacks to promote their use and misrepresented their safety. J&J agreed to pay more than $2.2 billion to settle criminal and civil allegations in November 2013. “The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” Attorney General Eric Holder said, according to a Department of Justice press release.

Janssen also pleaded guilty to promoting Risperdal in dementia patients, and agreed to pay a $400 million fine. The government alleged that Janssen created written ads to promote the off-label use and offered incentives to salespeople.

The government also alleged that Janssen promoted Risperdal for use in children and patients with mental disabilities. Allegedly, the company engaged in this conduct despite knowing that Risperdal could pose certain risks in children, including the risk of elevated prolactin levels.