Mortality and Antipsychotic Use in Dementia-Related Behavioral Disorders

In 2005, the U.S. Food and Drug Administration (FDA) added a Boxed Warning to all atypical antipsychotic medications based on the analysis of randomized controlled studies showing increased mortality in older adults with dementia-related psychosis. The Boxed Warning was later extended in 2008 to conventional antipsychotics. However, with additional scientific evidence becoming available and clinical practice guidance changes occurring since that time, as well as with the introduction of new treatments to the market, there is an opportunity to re-evaluate the need and value of the Boxed Warning included in the approved labeling of antipsychotic medications for impacted populations.

The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the FDA, is convening a virtual public workshop to review data regarding risks associated with the use of medications in the antipsychotic class in older adults with behavioral and psychiatric symptoms associated with dementia. Attendees will hear insights from experts on a re-analysis of the data that supported the regulatory action related to the Boxed Warning as well as findings from a recently conducted literature review. Workshop attendees will also hear reflections from participants on the available evidence and further considerations related to the assessment of risks associated with the use of antipsychotics within this patient population.

Attendees are encouraged to submit questions via the form below for consideration during the event. Moderated discussions will incorporate attendee questions submitted in advance as well as live via the webinar’s Q&A function as time permits.

This meeting is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [U19FD006602] totaling $5,192,495 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

The below form is for questions only. To register for the event, please click here.