A new report from Human Rights Watch contends that thousands of nursing home patients have been prescribed Risperdal or other antipsychotic medications to treat dementia, suggesting that many of these facilities are misusing the potentially dangerous drugs.
Antipsychotic medications like Risperdal are indicated to treat serious psychiatric disorder, such as bipolar disorder and schizophrenia. They are currently not approved to for use in elderly dementia patients.
In fact, the U.S. Food & Drug Administration (FDA) added a Black Box Warning – the strongest possible safety warning – to antipsychotic labels over a decade ago, advising that that they were associated with an increased risk of death when used in this very patient population.
The Human Rights Watch report was based on visits to 100 nursing facilities in six states. The group’s research team conducted more than 300 interviews with people living in the facilities, their families, staff, long-term care and disability experts, government officials, and advocates.
The investigation’s findings suggested that more than 179,000 nursing home residents, mostly older and living with dementia, are given antipsychotic drugs every week without an appropriate diagnosis.
“People with dementia are often sedated to make life easier for overworked nursing home staff, and the government does little to protect vulnerable residents from such abuse,” Hannah Flamm, NYU School of Law fellow at Human Rights Watch, said in a statement announcing publication of the report. “All too often, staff justify using antipsychotic drugs on people with dementia because they interpret urgent expressions of pain or distress as disruptive behavior that needs to be suppressed.”
These findings are not at all surprising to anyone who’s followed the controversial history of Risperdal.
Brought to market in 1993, Risperdal is indicated to treat adult and adolescent schizophrenia, bipolar disorder in adults and children ages 10-to-17, and irritability in children (5-to-16 years of age) with autistic disorder.
Risperdal has never been approved to treat elderly dementia patients. What’s more, its current pediatric indications weren’t approved by the FDA until October 2006.
In November 2013, the U.S. Department of Justice announced that Johnson & Johnson and its Janssen Pharmaceuticals unit had agreed to pay $2.5 million to resolve criminal and civil charges stemming from the marketing of Risperdal and other drugs. While the companies did plead guilty to illegally promoting the antipsychotic medication for use in elderly dementia patients, they admitted no wrongdoing in resolving allegations that Risperdal had been wrongly marketed for use in children long before such indications were ever approved by the FDA.
While doctors may prescribe FDA-approved medications for any purpose they see fit, pharmaceutical companies are legally prohibited from marketing their products for unapproved – i.e. off-label – indications.
Thousands of Risperdal lawsuits have been filed in courts around the country on behalf of men and boys who developed gynecomastia – a condition marked by the growth of female-like breasts – due to side effects allegedly associated with the antipsychotic medication. Many of these plaintiffs took Risperdal as children prior to October 2006 and claim that Johnson & Johnson wrongly marketed the drug for off-label pediatric indications
The Philadelphia Court of Common Pleas – home to one of the nation’s largest Risperdal litigations – has concluded numerous gynecomastia trials since February 2015. Five plaintiffs have been awarded compensatory damages ranging from $2.5 million to $70 million.
Several Risperdal gynecomastia lawsuits have also been resolved via confidential settlements just prior to trial.