Is Risperidone (Risperdal) contraindicated in the elderly?

Is Risperidone (Risperdal) Contraindicated in the Elderly?

Risperidone is not absolutely contraindicated in the elderly, but it carries an FDA black box warning for increased mortality risk when used in elderly patients with dementia-related psychosis and should be avoided for this indication. 1

FDA Black Box Warning and Mortality Risk

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs, including risperidone, have a 1.6 to 1.7 times increased risk of death compared to placebo-treated patients. 1
• In controlled trials, the death rate in drug-treated elderly dementia patients was approximately 4.5% versus 2.6% in placebo groups, with most deaths being cardiovascular (heart failure, sudden death) or infectious (pneumonia) in nature. 1
• Risperidone is NOT FDA-approved for the treatment of dementia-related psychosis. 1

Cerebrovascular Events

• Elderly patients with dementia-related psychosis treated with risperidone showed significantly higher incidence of cerebrovascular adverse events (stroke, transient ischemic attack) including fatalities compared to placebo. 1
• Mean age of affected patients was 85 years (range 73-97 years). 1

When Risperidone May Be Used in the Elderly

For approved psychiatric indications (schizophrenia, bipolar disorder) in elderly patients WITHOUT dementia-related psychosis, risperidone can be used with extreme caution at very low doses:

• Start at 0.25-0.5 mg daily and increase slowly by 0.25 mg increments. 2, 3
• The American Academy of Family Physicians identifies risperidone as having increased risk of extrapyramidal symptoms (EPS) if doses exceed 6 mg/24 hours, and particularly at doses >2 mg in elderly patients. 4
• Risperidone has the highest EPS risk among atypical antipsychotics (hierarchy from lowest to highest: quetiapine, aripiprazole, olanzapine, risperidone). 4

Deprescribing Recommendations

• The Mayo Clinic guidelines specifically list risperidone among atypical antipsychotics that should be avoided for cognitive behavioral problems in dementia, as they worsen cognitive function. 5
• Beers Criteria recommend tapering/avoiding antipsychotics if possible, especially for pharmacological behavioral control in cognitive disease; use redirection and other non-pharmacological interventions first. 5
• The FDA box warning emphasizes the risk of death when used for dementing disorders, and it is safe to taper to discontinuation, especially when there is perceived lack of benefit. 5

Safer Alternatives for Elderly Patients

If an antipsychotic is absolutely necessary for behavioral symptoms in elderly patients, quetiapine is preferred over risperidone:

• Quetiapine has the lowest risk of EPS among commonly used antipsychotics in elderly patients, with a starting dose of 25 mg. 4
• Aripiprazole (starting 5 mg) and olanzapine (starting 2.5-5 mg) are intermediate options with lower EPS risk than risperidone. 4

Critical Monitoring if Risperidone Must Be Used

If risperidone is used in elderly patients for approved indications:

• Monitor for orthostatic hypotension (29% incidence), symptomatic orthostasis (10%), and cardiovascular events. 2
• Watch for EPS (11% incidence), delirium (1.6%), and neuroleptic malignant syndrome. 1, 2
• Particular caution is required with cardiovascular disease, co-treatment with SSRI antidepressants or valproate, and rapid dose increases. 2
• Daily evaluation with in-person examination is recommended when using any antipsychotic in elderly patients. 4

Common Pitfalls to Avoid

• Never use risperidone for dementia-related behavioral symptoms - this is the black box warning scenario with highest mortality risk. 1
• Avoid doses above 1.25 mg in elderly patients, as side effects become more prevalent above 2.5 mg. 3
• Do not combine with other dopamine antagonists (metoclopramide, haloperidol) to prevent excessive dopamine blockade. 6
• Avoid rapid dose escalation - increase by only 0.25 mg weekly. 2, 3