The U.S. Food and Drug Administration (FDA) has determined that treatment of behavioral disorders in elderly patients with dementia with newer (atypical) antipsychotic medications is associated with increased mortality. Several studies show numerical increases in mortality in seniors treated with atypical antipsychotics compared to those treated with placebos. However, it is important to note that a causal relationship between the medications and mortality has not been definitively established.

Currently, none of the atypical antipsychotic medications are FDA-approved for the treatment of behavioral disorders in patients with dementia. However, they are being prescribed in an “off-label” manner by physicians. Off-label prescription means that a drug can be used for a purpose other than which it was originally intended, and that was not approved by the FDA. Physicians typically prescribe atypical antipsychotics for elderly patients with dementia only when the potential benefits of the drugs outweigh the risks.