Concern Over Risperdal Side Effects Heating Up

Washington, DCWhen Johnson & Johnson (J&J) agreed in early November of last year to pay more than $2.2 billion in criminal and civil fines to settle allegations of improperly promoting Risperdal to various patient constituencies, it was hailed as the third-largest pharmaceutical settlement in US history. Risperdal side effects can vary and can be serious, especially for elderly patients. More on that later.

However, the New York Times (11/5/13) pointed out at the time the settlement was announced that Risperdal (risperidone) represented about five percent of J&J’s total revenue for 2004. Company filings revealed that Risperdal, an antipsychotic, brought in $3.1 billion in sales for the fiscal year ending 2004. Were Risperdal to represent just five percent of total company revenues, the assumption is that J&J’s total revenues from all products for the year ending 2004 was much higher - likely tens of billions of dollars.

Nearly 10 years later, in late 2013, a settlement of $2.2 billion would presumably represent a drop in the bucket for the company, which stated in comments to the New York Times that it was looking forward to moving beyond the Risperdal issue.

The crux of the settlement, that almost exclusively excused J&J from admitting to any wrongdoing, involved allegations that J&J actively promoted Risperdal to patients who were not, according to uses approved by the US Food and Drug Administration (FDA), indicated to receive the medication.

The popular antipsychotic was first granted FDA approval in 1993, after testing primarily on patients suffering from schizophrenia, but was not approved for a wider population with mental disabilities or children until 2006. J&J is accused of promoting the use of Risperdal to doctors for use with children, well before 2006. The US government, as part of a whistleblower lawsuit recently unsealed, alleged that J&J sales reps targeted child psychologists and mental health treatment centers, advocating for Risperdal as an effective treatment for attention deficit hyperactivity disorder (ADHD) and obsessive-compulsive disorder, but without the proper regulatory approvals in place.

Medical doctors have always had the ethical freedom and authority to prescribe drugs for uses that don’t fall within the approved parameters of the FDA. However, manufacturers are not allowed, under any circumstances, to actively promote a drug to doctors or otherwise, for a use or indication that is not sanctioned by the FDA.

Use in elderly patients with dementia is another unapproved indication that landed the pharmaceutical giant in hot water, according to the report. Allegations contained in the whistleblower Risperdal lawsuit suggest that J&J saw a market for Risperdal in elderly patients with dementia and put together a dedicated sales force to promote Risperdal to doctors and medical professionals who primarily treated elderly patients.

According to the report, Risperdal could prove useful to help control patients with severe dementia symptoms in a residential setting such as a nursing home, including the possibility of hostility on the part of a dementia patient toward other residents. However, there is a risk for Risperdal stroke in older patients through the use of Risperdal, and the FDA is reported to have rejected repeated attempts by J&J to have Risperdal approved for geriatric use.

The prescribing label for Risperdal now references the risk to seniors, and warns against the use of Risperdal in patients with dementia.

Federal officials pointed out that Risperdal side effects can include the development of breasts in boys stemming from exposure to the hormone prolactin. It’s been reported that male breasts can even begin to discharge.

The New York Times reported that, as part of the settlement, a misdemeanor charge was entered on behalf of the company, but that no individuals were charged with wrongdoing - and the company generally escaped wrongdoing, in spite of paying the massive series of fines.

At the time of the settlement, a spokesperson for J&J issued a statement defending the safety and efficacy of its products, noting that the resolution of the allegations allows the company to move forward with the development of innovative solutions to improve and enhance the well-being of patients the world over.

Eric Holder, the US attorney general, was more blunt, stating that J&J’s practices “recklessly put at risk the health of some of the most vulnerable members of our society - including young children, the elderly and the disabled.”