Epoch HealthAn Antipsychotic Drug Gets FDA Green Light Despite Fourfold Higher Risk of Death

Medical Experts Question the Efficacy and Safety of New Alzheimer’s Drug Amid High Mortality Rates

The FDA’s recent approval of brexpiprazole, marketed as Rexulti, for treating agitation in Alzheimer’s patients has ignited a debate within the medical community. Despite poor clinical trial results and a fourfold increase in mortality risk, the drug received a green light, leaving healthcare professionals puzzled and concerned.

HCN Medical Memo
The approval of brexpiprazole raises serious ethical and safety considerations. The drug’s questionable efficacy and alarming mortality rates should prompt us to scrutinize not only this specific medication but also the broader regulatory processes that allowed its approval. As clinicians, we must remain vigilant and critical of new treatments, especially when they could potentially harm vulnerable populations like Alzheimer’s patients.

Key Points

• Brexpiprazole received FDA approval despite showing a fourfold increase in mortality risk compared to a placebo, according to a British Medical Journal investigation.
• Nina Zeldes, a drug safety advocate, urged the FDA to reject the drug, citing its lack of meaningful benefits and potential harm to patients.
• Clinical trials showed only a 5.3-point maximum reduction in Cohen-Mansfield Agitation Inventory (CMAI) scores, falling far short of the 17-point change considered clinically valuable.
• Lon Schneider, a professor at the Keck School of Medicine, noted that brexpiprazole’s results were similar to earlier trials of antipsychotics, all of which carry high safety warnings.

“Antipsychotic medications are especially dangerous among the nursing home population because of their potentially devastating side effects, including death. We cannot speak to the hypothetical future use of brexpiprazole; however, CMS will continue its efforts to reduce the prescribing of unnecessary antipsychotics in nursing homes.”
– CMS spokesperson

Additional Points

• Advocacy groups like the Alliance for Aging Research and Leaders Engage on Alzheimer’s Research (LEAD) have been cited as potential influences in the FDA’s approval decision.
• Brexpiprazole joins other antipsychotics in carrying a “boxed warning,” the FDA’s highest safety-related warning.
• Common adverse side effects include urinary tract infections, sleepiness, insomnia, and higher incidences of cardiovascular events.

More on Patient Safety