But the adverse events associated with antipsychotic use can be dangerous, especially in older adults. To warn people of these risks, the Food and Drug Administration (FDA) issued a black box warning for all antipsychotic medications.
Black Box Warning
Black box warnings are the most serious warnings the FDA issues. They warn doctors and patients about serious or life-threatening adverse drug reactions. Antipsychotics earned a black box warning because they are associated with increased rates of stroke and death in older adults with dementia.
Antipsychotics With Black Box Warnings
Both typical and atypical antipsychotic medications come with a black box warning. Below are just a few antipsychotic medications commonly prescribed for use in older adults with dementia. WARNING: Increased Mortality in Elderly Patients With Dementia-Related Psychosis 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 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. Observational studies suggest that similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. [DRUG BRAND NAME (drug generic name)] is not approved for the treatment of patients with dementia-related psychosis.
*Modal duration means that the most common length of the trials used was 10 weeks. Keep in mind that all antipsychotics come with a black box warning, not just those listed below.
Atypical Antipsychotics
Atypical antipsychotics are frequently used off-label to treat the mood and behavioral symptoms associated with dementia. Commonly prescribed atypical antipsychotics include:
Abilify (aripiprazole) Geodon (ziprasidone) Risperdal (risperidone) Seroquel (quetiapine) Zyprexa (olanzapine)
Typical Antipsychotics
Typical antipsychotics may also be prescribed for off-label use. Common typical antipsychotics for dementia include:
Haldol (haloperidol) Navane (thiothixene) Trilafon (perphenazine)
Typical antipsychotics tend to cause extrapyramidal symptoms—such as stiffness and immobility—and metabolic syndrome. Therefore, these drugs are rarely, if ever, prescribed for use in adults with dementia.
Why Antipsychotics Are Still Used
Psychosis and agitation in dementia can cause considerable distress to an older person or to their caregivers. Because there are a limited number of medications that can treat this condition, your loved one’s doctor may still use one or more antipsychotic medications that carry this black box warning. In a situation like this, the doctor will consider whether the potential benefits of using these medications are greater than the risks.
