The U.S. Food and Drug Administration’s (FDA) recent approval of the antipsychotic drug brexpiprazole (Rexulti) for treating agitation in elderly dementia patients has sparked concerns among medical professionals and health researchers.
The Controversial Efficacy and Safety Profile
According to the FDA’s pre-approval trials, Rexulti did not provide a clinically meaningful benefit and had a four times higher death rate compared to placebo.
Despite this, the drug was fast-tracked for approval, alarming many experts who believe that the small benefits do not outweigh the serious risks.
Economic Incentives
The makers of Rexulti, Otsuka and Lundbeck, project an additional $1 billion in annual sales from this approval.
Investigative journalist Robert Whitaker highlights concerns regarding the harm-benefit balance of the drug in an article published in The BMJ.
Impact on Regulatory Standards
Professor Lon Schneider from the Keck School of Medicine of the University of Southern California, and Nina Zeldes, a Public Citizen health researcher, both expressed concern that the FDA’s decision reflects a lowering of approval standards.
They believe that weak data could set a dangerous precedent for future drug approvals, especially for vulnerable patient groups like the elderly.
Patient Advocacy Groups and Commercial Interests
Patient advocacy organizations such as the Alliance for Aging Research and Leaders Engage on Alzheimer’s Research (LEAD) have urged the FDA for the approval of Rexulti.
These groups receive funding from Otsuka and other pharmaceutical companies, raising questions about possible conflicts of interest.
This decision is also expected to impact ongoing efforts by the U.S. Centers for Medicare and Medicaid Services (CMS) to minimize the off-label use of antipsychotic drugs in residential care homes.
Rexulti’s approval could potentially reverse years of effort aimed at safer drug prescribing practices in such facilities.
Expert Opinions
Erick Turner, a former FDA reviewer, suggests that clinician responses to the approval may be influenced by existing beliefs about prescribing antipsychotics for Alzheimer’s patients.
He also anticipates that key opinion leaders and drug reps will play a significant role in ‘educating’ clinicians.
The CMS has indicated that it will continue its efforts to reduce the prescription of unnecessary antipsychotics in nursing homes, but the new approval raises questions about how these efforts will align with the introduction of Rexulti into the market.
This controversial approval highlights the complexities involved in drug regulation, especially when vulnerable patient populations, high economic stakes, and evolving medical standards are involved.
It serves as a cautionary tale and calls for transparent, evidence-based practices in drug approvals.
If you care about dementia, please read studies about how the Mediterranean diet could protect your brain health, and Vitamin B supplements could help reduce dementia risk.
For more information about dementia, please read studies about high vitamin D level linked to lower dementia risk in diabetes, and results showing that coffee may help lower your risk of stroke, dementia.
The research findings can be found in The BMJ.
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