Posted on 09/25/2023 8:44:07 AM PDT by bitt
Investigation raises serious questions about the harm-benefit balance of Rexulti Decision may reverse efforts to reduce use of antipsychotics in US care homes
In trials, the antipsychotic drug brexpiprazole (Rexulti) failed to provide a clinically meaningful benefit and increased the risk of death. Yet the US Food and Drug Administration (FDA) has fast tracked its approval, making Rexulti the first antipsychotic for treating agitation in elderly patients with dementia.
At a cost of around $1,400 a month Rexulti’s makers, Otsuka and Lundbeck, are forecasting an additional $1 billion in annual sales, but there are serious questions about the harm-benefit balance of this drug, writes investigative journalist Robert Whitaker in The BMJ today.
The decision may also reverse years of effort by the US Centers for Medicare and Medicaid Services (CMS) to reduce the widespread off-label use of antipsychotics in residential care homes.
Like other antipsychotics, the drug carries a “boxed warning,” FDA’s most serious type of warning, informing prescribers of increased risk of death. And in the three pre-approval trials, the FDA concluded that the death rate was four times higher in those given brexpiprazole compared to those given placebo.
On efficacy, the drug showed a maximum 5.3-point improvement over placebo on a 174-point scale, far short of the 17 points considered to be clinically important.
“The small benefits do not outweigh serious safety concerns,” Public Citizen health researcher Nina Zeldes told the FDA’s Advisory Committee prior to the approval. “Like other antipsychotics, this is a drug that can kill patients without providing a meaningful benefit.”
(Excerpt) Read more at bmj.com ...
It will be cool if this is an mRNA drug.
Increasing the death rate in memory care units would greatly reduce the expenditures on Medicare.
“Increasing the death rate in memory care units would greatly reduce the expenditures on Medicare.”
Not just memory care units, all old folks who are not in the physical shape of a 40 year old.
I notice you’re speaking of your mother in the past tense... let me guess, she suffered from “Neuroleptic Malignancy Syndrome.” Anybody curious about how these antipsychotics take the life of dementia patients, you should Google NMS and be able to recognize the symptoms. The VA Hospital pushed the antipsychotics on my husband. It took less than 6 weeks to end his life. The fact that the hospice doctor admitted that he “likely” succumbed to NMS was a shock. It was only after the fact that I was informed of this common outcome to the use of antipsychotics. I would not have consented to their use if I had known.
Yes, Mom’s gone. I’ll have to look up NMS. Thanks.
Are they giving it to Dementia Joe Biden?
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