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ASCP, Alliance Applaud Congress for Directing FDA to Re-evaluate Boxed Warning and Data for Antipsychotics in Older Adults

Published March 18, 2024

Variety of pills

WASHINGTON, DC (March 18, 2024) — Members of Project PAUSE (Psychoactive Appropriate Use for Safety and Effectiveness) are championing the results of the recently enacted FY24 Appropriations Bill which directs the U.S. Food & Drug Administration (FDA) to hold a public workshop focused on the application of black box warnings for antipsychotics, specifically in older adults. The inclusion of this language is part of the ongoing work of  the coalition, co-convened by the American Society of Consultant Pharmacists (ASCP) and the Alliance for Aging Research to ensure safe and appropriate access to treatments for mental health conditions and the neuropsychologic symptoms of neurodegenerative diseases like Parkinson’s Disease, Alzheimer’s Disease and dementia.

“This workshop is a significant step toward ensuring safe and appropriate use of antipsychotics for older individuals residing in long-term care facilities,” said ASCP CEO Dr. Chad Worz, PharmD. “ASCP is proud to have supported this required FDA public workshop and review of pertinent data related to risk. It is crucial that black box warnings are scientifically accurate in order to promote patient safety and quality care. Additionally, ASCP will continue to engage CMS on re-evaluating its outdated quality metrics for antipsychotic use in the long-term care setting to ensure residents have access to appropriate, evidence-based care.”

Neuropsychiatric symptoms – disabling behavioral and psychological symptoms of dementia- can include apathy, disinhibition, socially inappropriate behavior, difficulty finding one’s way and completing basic tasks, depression, auditory hallucinations, psychosis, anger, aggression, anxiety, fear, sleep issues, sundowning, visual hallucinations, delirium, mood swings, disorientation, and paranoia. If current demographic and health trends continue, more than 9 million Americans could have one or more types of dementia by 2030 and nearly 12 million by 2040.

“There is a large unmet medical need in long-term care settings for the diagnosis and management of NPS in dementia,” said Alliance for Aging Research President & CEO Sue Peschin, MHS. “Despite scientific evidence pointing towards shifts in clinical protocols since 2008, the FDA has yet to reassess the necessity and effectiveness of the boxed warning attached to the approved labels of antipsychotic medications. We’re thankful to Congress for recognizing that fact, especially as one on-label therapy for agitation in Alzheimer’s dementia has been approved by the Agency and others are in clinical development. Older adults deserve access to the most appropriate care, and we will continue to work with policymakers towards that goal.”

The FDA was instructed to “review the data regarding risks associated with the use of medicines…the antipsychotic class in older adults with mental health conditions associated with dementia and the appropriateness of the broad application of this boxed warning for all medicines within this class.” An update on the review and the public workshop must be provided by the FDA in 12 months.  

Congress notes, “FDA has not re-evaluated the need and value of the boxed warning included in the approved labeling of antipsychotic medications since 2008, despite additional scientific evidence, clinical guidance changes and new medicines entering the market.” The direction for the FDA to hold a public workshop focused on antipsychotics’ black box warning aligns with Project PAUSE’s stance that antipsychotics should be utilized in an appropriate and safe manner in older adults that is up to date with scientific evidence.  

Project PAUSE applauds this step in remedying a dire situation for millions of Americans and their families facing Alzheimer’s and dementia on a daily basis.


Project PAUSE is a coalition of national patient and provider organizations that advocates on clinical care issues in long-term care community with a focus on improving the quality of life and care for individuals living with neurodegenerative diseases, such as Alzheimer’s Disease and related dementias. Project PAUSE is dedicated to ensuring that all individuals in long-term care settings who have Alzheimer’s disease, dementia, and other neuropsychiatric conditions receive high-quality, patient-centered, appropriate care and treatment without facing stigma or barriers.

The American Society of Consultant Pharmacists (ASCP) is the only international professional society devoted to optimal medication management and improved health outcomes for all older persons. ASCP’s members manage and improve drug therapy and improve the quality of life of geriatric patients and other individuals residing in a variety of environments, including nursing facilities, sub-acute care and assisted living facilities, psychiatric hospitals, hospice programs, and home and community-based care.

The Alliance for Aging Research is dedicated to changing the narrative to achieve healthy aging and equitable access to care. We strive for a culture that embraces healthy aging as a greater good and values science and investments to advance dignity, independence, and equity.

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