Despite US Food and Drug Administration (FDA) warnings to avoid using antipsychotic medications to treat behavioral symptoms in elderly patients with dementia because they are associated with an increased risk of death, such use remains a common practice in some nursing facilities. A new study published in the BMJ suggests that the risks may vary among the drugs in this class, information that may help guide physicians toward prescribing less risky options.
In 2005, the FDA warned that atypical antipsychotic drugs increased the risk of death in elderly patients with dementia and that such unapproved use of this class of drugs should be avoided. The warnings were later extended to older-generation antipsychotics in 2008. But a 2011 report from the Department of Health and Human Services Office of the Inspector General found such use remains common: 14% of elderly nursing home residents have a Medicare claim for the drugs, and the vast majority of these prescriptions are for off-label use, particularly for use in dementia patients. The study’s authors explained that although behavioral interventions are recommended as a first-line choice, many interventions have not been rigorously studied, may be difficult for nursing homes to implement because of limited resources, or may provide inadequate control of severe or recurrent symptoms.
“In the absence of proved effective and safe alternative pharmacological treatments, it is likely that antipsychotic drugs will continue to be used widely, despite the fact that they have not been approved for this indication, their use cannot be justified as evidence based, and there are clear data confirming their associated risk,” the authors concluded.
To provide clinicians with data that may help guide safer use, Krista F. Huybrechts, MS, PhD, of Brigham and Women’s Hospital and Harvard Medical School, and her colleagues compared the risks among various antipsychotics to determine if some may be safer for this vulnerable population. The team used data from Medicaid, Medicare, the Minimum Data Set, the National Death Index, and a nursing home quality assessment involving more than 75 000 individuals aged 65 years or older who were new users of antipsychotic medications. They found that patients treated with haloperidol had twice the risk of dying compared with those treated with risperidone, while patients treated with quetiapine had a reduced risk. No differences were seen between other antipsychotic medications.
The authors emphasize the importance of trying behavioral interventions first in such patients but note that the findings may help when medication use is deemed necessary.
“If the clinician faces a situation in which use of these drugs seems inevitable, our findings underscore the importance of always prescribing the lowest possible dose and of closely monitoring patients, especially shortly after the start of treatment,” the authors state. “The evidence accumulated so far implies that use of haloperidol in this vulnerable population cannot be justified because of the excess harm. Quetiapine might be somewhat safer than other atypical drugs, but these findings will require replication in other studies.”