FDA Approves Antipsychotic That Provides No Meaningful Benefit But Increases Risk of Death


From the BMJ: Robert Whitaker writes on the FDA’s approval of brexpiprazole for agitation in Alzheimer’s patients. In clinical trials, the drug provided no meaningful clinical benefit, no improvement in quality of life for patient or caregiver, and increased the risk of death.


  1. Great review of a drug approval engineering set of studies!.

    The researchers, or their backers, the engineers, were really good at setting conditions for passing a drug through the approval goal post.

    And with a little help from the NGOs.

    I speculate that the countries where the benefit of the drug were countries that perhaps the practitioners are a little more adept at picking up the side effects of neuroleptics in the elderly, and therefore could bias more easily their meassurements.

    Sad that after the publicity of deaths because of neuroleptics, in part by the NYT (they quoted a 2% mortality rate I think in the first month, maybe first three months) and MIA, they changed to anticonvulsants. Changed the procedures and supervision of administration of sedating drugs in the elderly.

    And now they approved a “new” formal indication for a medication that causes that which previous decisions and changes deemed too risky. I think I remember they even chaged the diagnostic culture, too many elders with schizophrenia diagnosis. So, they also had to tone it down to “agitation”.

    Hence probably the new study, too many changes to the status quo.

    And with a higher risk than the previously used medication!.

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  2. I expect that, probably, navigating agitation among patients with dementia is a significant challenge for caregivers. There could be bias towards approving any measure that could help.

    People who have dementia are disabled from advocating for their own comfort. Distress over conditions in which they are held could contribute meaningfully to manifestations of agitation.

    I would imagine that many who are diagnosed with Alzheimer’s might prefer assisted suicide to a prolonged subsistence under conditions they do not enjoy.

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