Educational only — not medical advice.

Antipsychotic medications such as Risperdal, Abilify, Seroquel, Zyprexa, Clozaril, Geodon, and Symbyax were developed to treat conditions like schizophrenia, bipolar disorder, and severe mood disorders. Although these drugs were never approved for dementia, they became widely used to manage agitation, aggression, and behavioral symptoms in older adults living with dementia.

In 2005, the U.S. Food and Drug Administration (FDA) issued a safety warning based on evidence that these medications increased mortality risk in elderly dementia patients. Today — nearly two decades later — the warning still stands, and subsequent research has strengthened the concerns.

Historical Context: The 2005 FDA Warning

In April 2005, the FDA reviewed 17 clinical trials involving several atypical antipsychotic medications. Across studies, elderly dementia patients taking these drugs had:

  • 1.6–1.7 times higher risk of death compared to placebo

  • Increased rates of cardiovascular events (heart failure, sudden death)

  • Increased rates of infectious complications, particularly pneumonia

Because of these findings, the FDA required a boxed warning — the strongest warning label available — on all atypical antipsychotics. A warning about increased stroke risk was added to specific drugs like Abilify.

This guidance made clear that these medications are not approved for dementia-related psychosis.

What We Know Now (2005–2024): Risks Are Even More Clear

Since the original FDA action, additional studies have confirmed and expanded upon the risks:

1. Increased Mortality

Large observational studies from the 2010s and 2020s show that both atypical and typical antipsychotics elevate mortality risk in elderly dementia patients. Some data suggest that:

  • Risk is highest in the first 30–90 days of use

  • Haloperidol (a typical antipsychotic) may pose even higher mortality risk than atypicals

2. Higher Risk of Stroke and Cardiovascular Problems

Meta-analyses continue to show increased incidence of:

  • Stroke and transient ischemic attack

  • Sudden cardiac death

  • Arrhythmias

3. Pneumonia and Infections

Antipsychotics appear to reduce the ability to clear secretions and may depress swallowing reflexes, contributing to a higher risk of:

  • Aspiration

  • Pneumonia

4. Falls, Sedation, and Cognitive Decline

Because these drugs can cause drowsiness, motor instability, and impaired balance, they are associated with:

  • Falls

  • Fractures

  • Worsening confusion in some individuals

5. Additional Findings

Recent studies suggest that antipsychotics may also:

  • Increase metabolic stress (blood sugar, lipids)

  • Interfere with autonomic regulation

  • Worsen overall functional decline

Current FDA and Clinical Guidance

Today, the boxed warning remains in place for all antipsychotics — both typical and atypical. Federal agencies including the CDC and Centers for Medicare & Medicaid Services (CMS) have issued strong guidance encouraging:

  • Behavioral and environmental strategies first

  • Antipsychotics only when behaviors pose a risk to the patient or others

  • The lowest effective dose, for the shortest duration possible

  • Frequent attempts to reduce or discontinue the drug when appropriate

The American Geriatrics Society (AGS) and Choosing Wisely initiative consistently warn against routine antipsychotic use for dementia behaviors.

Why This Still Matters

Although this issue first gained attention in 2005, the core message has not changed — if anything, the evidence is now more compelling:

  • Antipsychotics can increase mortality in elderly dementia patients.

  • They are not approved for dementia-related behavioral symptoms.

  • Non-drug approaches remain the first choice.

Families, caregivers, and clinicians often face challenging situations when dementia causes agitation or aggression, but understanding the risks helps inform safer, more supportive care decisions.