If someone you know has Alzheimer’s disease or vascular dementia, they may experience various symptoms that are not related to memory, including aggression, agitation, delusions, and hallucinations. In order to solve these challenging symptoms, doctors usually prescribe antipsychotic drugs.
However, adverse events associated with the use of antipsychotics can be dangerous, especially in the elderly. To warn people of these risks, the U.S. Food and Drug Administration (FDA) has issued a black box warning for all antipsychotic drugs.
Black box warning
The boxed warning is the most serious warning issued by the FDA. They warned doctors and patients about serious or life-threatening adverse drug reactions. Antipsychotics received a black box warning because they were linked to strokes and increased mortality in Alzheimer’s.
Antipsychotic black box warning (full text)
Warning: Increased mortality in patients with Alzheimer’s-related mental illness
Patients with Alzheimer’s disease-related psychosis receiving antipsychotic drugs have an increased risk of death. An analysis of 17 placebo-controlled trials (modal duration* of 10 weeks), mainly for patients taking atypical antipsychotics, showed that the risk of death for drug-treated patients was 1.6 to 1.7 times that of placebo-treated patients . During a typical 10-week controlled trial, the mortality rate for drug-treated patients was approximately 4.5%, while the mortality rate for the placebo group was approximately 2.6%.
Although the causes of death vary, most deaths appear to be cardiovascular disease (such as heart failure, sudden death) or infectious (such as pneumonia). Observational studies have shown that, similar to atypical antipsychotics, treatment with conventional antipsychotics may increase mortality. The extent to which the increased mortality in observational studies is attributable to antipsychotic drugs rather than certain characteristics of the patient remains unclear.
[DRUG BRAND NAME (drug generic name)] It is not approved for the treatment of patients with mental illness related to dementia.
*Modal duration means that the most common test length is 10 weeks.
Antipsychotics with a black box warning
Both typical and atypical antipsychotics have black box warnings. The following are some of the antipsychotic drugs commonly used in patients with Alzheimer’s disease.
please remember all Antipsychotics carry black box warnings, not just the ones listed below.
Atypical antipsychotics are often used to treat the emotional and behavioral symptoms associated with dementia. Commonly used atypical antipsychotics include:
Typical antipsychotic drugs may also be prescribed for off-label use. Common and typical antipsychotic drugs include:
Typical antipsychotics often cause extrapyramidal symptoms-such as stiffness and immobility-and metabolic syndrome. Therefore, these drugs are rarely (if any) used for adult dementia.
Why antipsychotics are still used
The mental illness and restlessness in dementia can cause considerable suffering to the elderly or their caregivers. Due to the limited number of drugs that can treat this condition, your loved one’s doctor may still use one or more antipsychotic drugs with this black box warning. In this case, doctors will consider whether the potential benefits of using these drugs outweigh the risks.of