New research provides additional evidence that off-label prescribing of antipsychotic drugs for elderly patients with dementia is not effective in reducing behavioral symptoms and exposes them to risks of serious side effects.
by CCHR National Affairs Office
Antipsychotic drugs significantly worsened behavior in two out of three nursing home residents using the drugs, a new study indicates. The researchers say their findings support the importance of focusing on approaches other than the use of antipsychotics for the behavioral symptoms of elderly patients. The Citizens Commission on Human Rights (CCHR) urges caregivers and family members to report any instance of harm or abuse from the use of antipsychotics to CCHR, as well as the Centers for Medicare and Medicaid Services (CMS).
The new study explored the association between antipsychotics and worsening behavior in patients in long-term care facilities. Antipsychotics are commonly prescribed for agitation or other behavioral disturbances in older people with dementia.
Researchers at the University of Waterloo in Ontario, Canada, analyzed data from nearly 500,000 Canadian nursing home residents from 2000 to 2022 and found that nearly 68% of the residents who used antipsychotics had worse behavioral problems during follow-up checks.
“Our findings support the importance of focusing on non-pharmacological approaches to care, especially in the setting of those experiencing BPSD [behavioral and psychological symptoms of dementia],” the researchers concluded.
The study further found that 26% of nursing home residents in Canada were prescribed antipsychotics for off-label uses not approved by the FDA.
“Sometimes people may say they don’t have enough staff to deal with these issues, but the reality is that these medications can make disability and cognitive impairment worse,” said John Hirdes, Ph.D., a professor in the School of Public Health Sciences at Waterloo University who was part of the research team.
The researchers recommended getting to the source of dementia patients’ behavioral issues and providing non-drug support first. That support may be in the form of better pain management, activities to reduce anxiety, gentle exercise, or music and art therapy, which have been shown to improve behavioral symptoms without the need for antipsychotic drugs.
“Although the positive effects of non-pharmacological treatment are widely discussed in the [medical] literature, these approaches are infrequently and inconsistently implemented,” the researchers wrote. The study was published in the Journal of the American Medical Directors Association.
In 2005, the U.S. Food and Drug Administration (FDA) issued its most serious “black box” warning for atypical (second-generation) antipsychotics, including Abilify, Zyprexa, Seroquel and Risperdal, after finding the drugs nearly double the rate of death in elderly dementia patients. In 2008, the FDA extended the warning to all antipsychotics by including typical (first-generation) antipsychotic drugs, such as Haldol, Thorazine and Prolixin, and added a warning for stroke and other cerebrovascular adverse events in elderly patients with dementia.
Atypical antipsychotic drugs, initially promoted as safer than older generation antipsychotics, not only failed to prove safe when used for behavioral treatment in older adults with dementia, but also failed to show evidence of effectiveness, a 2013 study found.
Antipsychotics carry the risks of serious side effects, including tremors, anxiety, confusion, restlessness, rigidity, tardive dyskinesia (uncontrollable muscle movements), cognitive decline, stroke, cardiovascular events, and an increased risk of death in elderly dementia patients that prompted the FDA warning.
The CMS National Partnership to Improve Dementia Care in Nursing Homes worked successfully to reduce the percentage of long-term nursing home residents in the U.S. who are prescribed antipsychotic drugs from 23.9% in 2011 to 14.8% at the end of 2023, but the rate hit a low of 14% in 2019 and has risen since then. Some 2.2 million Americans aged 65 and older are currently prescribed antipsychotic drugs.
Resident rights in the federal regulations for long-term care facilities prohibit the use of medications for discipline or the convenience of others. CCHR urges caregivers and family members to report any wrongful prescribing of antipsychotics to nursing home patients by contacting CCHR, as well as CMS.
WARNING: Anyone wishing to discontinue or change the dose of an antipsychotic or other psychiatric drug is cautioned to do so only under the supervision of a physician because of potentially dangerous withdrawal symptoms.