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FDA Should Reject Approval of Dangerous Antipsychotic to Prevent Harm to Agitated Patients with Alzheimer’s Dementia

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should reject the approval of the additional indication of the antipsychotic brexpiprazole, marketed under the brand name Rexulti, for the treatment of agitation associated with Alzheimer’s dementia, Public Citizen said today in a letter to the agency.

An approval likely would exacerbate the inappropriate use of this dangerous antipsychotic drug in nursing homes, where residents are already being irresponsibly prescribed sedating and potentially deadly antipsychotic drugs.

“We already know that brexpiprazole, like all other antipsychotics, has a black box warning because of the increased risk of death among elderly patients with dementia,” said Nina Zeldes, health researcher for Public Citizen’s Health Research Group. “The small benefits of this drug do not outweigh this risk.”

Public Citizen also sent the letter over concerns that the FDA did not adequately address the crucial issue of whether a specific population group could be identified in whom the benefits outweigh its risks, either before or during the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee on April 14, 2023.

Despite acknowledging this lack of data during the meeting, the Committees almost unanimously recommended the additional approval for brexpiprazole (9 yes, 1 no, 0 abstention).

“Patients and caregivers deserve to know whether there is a specific patient group that would benefit from this drug, especially given the increased mortality risk of antipsychotic drugs,” added Zeldes. “An approval of this drug will only provide false hope for the large number of desperate families of patients with Alzheimer’s dementia.”