Antipsychotics Black Box Warning for Elderly Patients

Doctor discussing prescription with senior patient

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If you have a family member or friend suffering from Alzheimer's disease, vascular dementia, or another type of dementia, they may be experiencing behavioral and psychological symptoms, including psychosis, delusions, and hallucinations. While antipsychotics are widely used by clinicians to treat these dementia-related symptoms in elderly patients, it's important to know that these medications come with a black box warning for this population specifically.

In 2005, the U.S. Food and Drug Administration (FDA) issued a black box warning that atypical antipsychotics were associated with a 60% to 70% increased risk of death in older people with dementia. This boxed warning was expanded to include typical antipsychotics in 2008.

Antipsychotic Black Box Warning (full text)


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 infections (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.

Antipsychotic Medications With Black Box Warnings

The antipsychotics that carry this black box warning include both atypical (second-generation) antipsychotics and the older typical (first-generation) antipsychotics, including:

Atypical Antipsychotics

The following atypical antipsychotics are among the most commonly prescribed medications used to treat mood and behavioral symptoms associated with dementia:

  • Abilify (aripiprazole)
  • Caplyta (lumapeterone)
  • Clozaril (clozapine)
  • Fanapt (iloperidone)
  • Geodon (ziprasidone)
  • Invega (paliperidone)
  • Latuda (lurasidone)
  • Rexulti (brexipiprazole)
  • Risperdal (risperidone)
  • Saphris (asenapine)
  • Seroquel (quetiapine)
  • Vraylar (cariprazine)
  • Zyprexa (olanzapine)

Typical Antipsychotics

There are also many different typical antipsychotics used to treat dementia. Some of the most commonly prescribed typical antipsychotics for dementia include:

  • Compro (prochlorperazine)
  • Haldol (haloperidol)
  • Loxitane (loxapine)
  • Mellaril (thioridazine)
  • Moban (molindone)
  • Navane (thiothixene)
  • Orap (pimozide)
  • Prolixin (fluphenazine)
  • Stelazine (trifluoperazine) 
  • Thorazine (chlorpromazine)
  • Trilafon (perphenazine)

Why These Medications 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.

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