Off Label Risperdal Use in Elderly Puts Seniors at Risk

Consumer watchdog group Public Citizen warns of the dangers associated with off-label use of prescription medications among the elderly, including atypical antipsychotics like Risperdal. Their recent newsletter cites disturbing research that shows at least 20 percent of prescriptions doled out in nursing homes over the past 15 years were inappropriate or misprescribed, putting seniors at unnecessary risk for serious complications and even death.

“In the U.S. alone, misprescribing ultimately leads to millions of preventable adverse events and more than 100,000 deaths annually… It wastes billions of dollars within our health care system,” states their recent publication Worst Pills, Best Pills. Similar concerns were highlighted in an April 12 Boston Globe article that delved into the hidden perils of antipsychotic misuse in assisted living facilities, where Risperdal is frequently administered to control agitated behavior in elderly residents suffering from dementia or Alzheimers’s. In one nursing home, at least 19 percent of residents were given the powerful drug, exposing them to Risperdal dangers including increased risk of lethal infections, sudden drops in blood pressure, heart rhythm disturbances and death, according to the FDA.

Risperdal side effects may prove fatal in elderly patients

The rampant misuse of drugs like Risperdal continues despite FDA warnings and others in the medical community stressing that antipsychotics should not to be used to treat individuals with Alzheimer’s disease and/or dementia. “We have an inordinate amount of prescriptions written for a population that is already frail, and we know these drugs increase the risk for side effects, including death,’’ explained Dr. Michael Gloth, a Johns Hopkins University School of Medicine associate professor, “So why are they being written?’’

Data collected by the Boston Globe shows that antipsychotics are administered to a significant percentage of nursing home residents, regardless of the fact that they don’t suffer from psychosis or other FDA-approved conditions that warrants their use. Risperdal is approved for the treatment of bipolar disorder and schizophrenia, but has been pushed on other patients for off-label uses, despite evidence of potentially fatal side effects. In fact, Risperdal manufacturer Ortho-McNeil Janssen – a unit of J&J – clearly warns of increased mortality rates among elderly patients with dementia who are given the drug.

The website states:  “Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. RISPERDAL is not approved for the treatment of patients with dementia-related psychosis.”

Risperdal dangers subject of increasing litigation

The over prescription of antipsychotics like Risperdal, Zyprexa and Seroquel for off-label use in nursing homes is under intense scrutiny, as more media coverage has been focused on the deadly consequences of such actions. Johnson & Johnson has already been accused of paying some $50 million in kickbacks to a pharmaceutical supply company to distribute Risperdal in nursing homes. Many relatives of elderly who were given the drugs as a form of chemical restraint say that their effects leave patients in a permanent stupor and at greater risk for falls and other preventable injuries. In some Risperdal lawsuits, plaintiffs claim that misuse of the drug in an assisted care facility caused their loved one to suffer heart failure and premature death.