Last reviewed: December 2010
More than five years after the Food and Drug Administration warned that drugs routinely prescribed to nursing-home residents posed serious threats, including an increased risk of death, inappropriate use remains high, according to a recent analysis by the American Society of Health-System Pharmacists (ASHP). The project is part of a CRH Best Buy Drugs ongoing investigation of medication prescribed “off-label.”
The drugs in question, atypical antipsychotics, are approved by the FDA to treat bipolar disorder and schizophrenia. But they’re frequently used off-label to control agitation, aggression, hallucinations, and other behavioral symptoms in elderly patients with Alzheimer’s disease or other forms of dementia. There are no FDA-approved drugs to treat these behavioral symptoms, but doctors can legally prescribe any drug for any reason they deem appropriate.
But those medications—such as aripiprazole (Abilify); olanzapine (Zyprexa); quetiapine (Seroquel); and risperidone (Risperdal and generic)—pose substantial risks, especially to older people, that include diabetes, movement disorders (some permanent), pneumonia, stroke, weight gain, and even sudden cardiac death.
“There is limited evidence for the efficacy of these medications and evidence of significant safety risks,” says E. Ray Dorsey, M.D., an associate professor of neurology at the Johns Hopkins University School of Medicine. “In addition, many of the people receiving them have limited capacity to weigh the risks and benefits of taking them.”
According to FDA estimates, the rate of death among elderly dementia patients with behavioral problems who received antipsychotics was about 4.5 percent over the course of a typical 10-week controlled trial, compared with about 2.6 percent for a placebo group. This prompted the FDA to require black-box warnings—the strongest type—to be added to the labeling of atypical antipsychotic medications in 2005. The FDA broadened the warning in 2008 to include the labels on “typical” or older antipsychotics, including chlorpromazine (only available as a generic now) and haloperidol (Haldol and generic).
What measures should you try first?
In a study published in the 2010 Archives of Internal Medicine, researchers found that the use of antipsychotics often began during a patient’s first week in a nursing home. That suggests that behavioral interventions—the treatment of choice—are used minimally, if at all.
“The patient is scared and upset in a strange environment, and the caregiver may lack training in how to respond,” explains Kenneth Brubaker, M.D., a geriatrician and board member of the American Medical Directors Association (AMDA), a group of health professionals who work in nursing homes and assisted living facilities.
“I would advocate that a family member be present as much as possible during the adjustment period, because that’s the patient’s only contact with reality,” says Brubaker. “Having frequent phone conversations between patient and family help, as do looking through family photo albums together or compiling a DVD of the patient’s life story to remind them of the past.”
Frontline caregivers—who deal directly with residents with dementia-related behavioral problems—often have limited skills in using such approaches, Brubaker says. At those nursing homes, according to Brubaker, agitated new residents are likely to be quieted with antipsychotic drugs in lieu of family photos.
This off-label drug use report is made possible through a collaboration between Consumer Reports Best Buy Drugs and the American Society of Health-System Pharmacists. This is the18th and 19th in a series based on professional reports prepared by ASHP.
These materials were made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by a multistate settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).