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Alarm as FDA fast-tracks first antipsychotic for dementia agitation
bmj.com ^ | 8/17/2023 | bmj.com

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 ...


TOPICS: Business/Economy; Culture/Society; Extended News; Government
KEYWORDS: dementia; fda; rexulti
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1 posted on 09/25/2023 8:44:07 AM PDT by bitt
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To: null and void; aragorn; EnigmaticAnomaly; kalee; Kale; AZ .44 MAG; Baynative; bgill; bitt; ...

also see: (if you have access..)

https://www.theepochtimes.com/mkt_app/health/highly-prescribed-drug-gets-fda-green-light-despite-4-fold-higher-risk-of-death-5491461


2 posted on 09/25/2023 8:45:28 AM PDT by bitt (<img src=' 'width=40%>)
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To: bitt

I’m all for it. They know what they’re doing.


3 posted on 09/25/2023 8:46:34 AM PDT by ComputerGuy (Heavily-medicated for your protection)
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To: JonPreston
Just in time for some of our FRiends on the other side of the Special Military Operation aisle.  
4 posted on 09/25/2023 8:49:12 AM PDT by kiryandil (China Joe and Paycheck Hunter - the Chink in America's defenses)
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To: bitt

Biden needs it, stat!


5 posted on 09/25/2023 8:51:02 AM PDT by Obadiah
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To: kiryandil

Josef Stalin perfected the art of using psychiatry as a weapon against political opponents.


6 posted on 09/25/2023 8:58:32 AM PDT by NorthMountain (... the right of the peopIe to keep and bear arms shall not be infringed)
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To: kiryandil

Yep, and just wait until they roll the next Trump stun grenade into the front door of Country Club :)


7 posted on 09/25/2023 9:01:44 AM PDT by JonPreston ( ✌ ☮️ )
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To: bitt

Good old thorazine is cheap.


8 posted on 09/25/2023 9:06:53 AM PDT by blackdog ((Z28.310) My dog Sam eats purple flowers.)
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To: bitt

The FDA needs to be a QC only operation.

I’m OK with them making sure that things are labeled correctly, and even testing for carcinogenicity, but beyond that? No one, anywhere, should have a say on what I put into my body. It is simply nowhere in the Constitution nor should any entity say ‘you may not make, purchase, or consume this substance’.


9 posted on 09/25/2023 9:07:50 AM PDT by Republican in occupied CA (We had enough government in 1789)
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To: bitt

“You will likely die, but you will no longer be angry.
Plus with the first thousand prescriptions I get a luxury cruise.

“Hey! Get your Covid vaxx on the way out. We need 75% practice compliance
to get our end of the year bonuses.

“ It’s “science-based medicine.”

- doctor


10 posted on 09/25/2023 9:12:11 AM PDT by aMorePerfectUnion (Fraud vitiates everything)
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To: bitt
---- "antipsychotic for dementia agitation"

Waiting for the mandates.... 1. 2. 3.....

11 posted on 09/25/2023 9:22:48 AM PDT by Worldtraveler once upon a time (Degrow government)
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To: bitt

It’s bad enough that we are using psychotropic drugs to turn our young children into killers.
Now we are going to turn our old into killers too?

(If you are unfamiliar with what I’m saying, all of the school shooters had one thing in common...use of or withdrawal from psychotropic drugs)


12 posted on 09/25/2023 9:37:47 AM PDT by joe fonebone (And the people said NO! The End)
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To: bitt

I’m 76. I had two minor strokes last winter probably brought on by anxiety. The neurologist said vasospasm. First, she wanted me on BP pills. I said but my BP is actually low. It was only high because I was in the hospital. After a month I had to stop because my BP was too low. Next, she wanted to put me on a cholesterol medication. I said no because my LDL cholesterol was low, as was my Total cholesterol. Finally she wanted me to take anxiety medication. You know the ones that have worse side effects than what you are being treated for. Drs no longer treat and work for the patient. They work for Big Pharma.


13 posted on 09/25/2023 9:53:47 AM PDT by heylady
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To: bitt

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 anti psychotics, this is a drug that can kill patients without providing a meaningful benefit.”

This sounds like a great followup drug for patients not dying after their Covid jabs.


14 posted on 09/25/2023 9:53:59 AM PDT by Grampa Dave (Those, who can make you believe in absurdities, can make you commit atrocities!!" ~ (Voltaire)!, )
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To: bitt

If Biden going to be the first in line to get this new med????


15 posted on 09/25/2023 10:31:30 AM PDT by kagnew
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To: bitt

They are trying to exterminate the species as quick as possible. And make big bucks as they do it.


16 posted on 09/25/2023 11:07:59 AM PDT by Openurmind (The ultimate test of a moral society is the kind of world it leaves to its children. ~ D. Bonhoeffer)
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To: Openurmind

In the Third Reich they dragged you off to the death camps on their nickel.

Now the Fourth Reich makes you pay for the privilege....


17 posted on 09/25/2023 11:11:23 AM PDT by cgbg ("Creative minds have always been known to survive any kind of bad training." Anna Freud.)
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To: cgbg

“Now the Fourth Reich makes you pay for the privilege....”

Quite crafty isn’t it? They got it down to a science now. They get their piece of the pie through the chain yet the undertaker still gets his full price in the end.


18 posted on 09/25/2023 11:55:16 AM PDT by Openurmind (The ultimate test of a moral society is the kind of world it leaves to its children. ~ D. Bonhoeffer)
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To: bitt

Start human testing on $h!tter Joe


19 posted on 09/25/2023 12:45:36 PM PDT by BigFreakinToad (Remember the Biden Kitchen Fire of 2004)
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To: bitt

My mother needed something to calm her down in the locked memory care unit. I hated it, but the alternative was she would stand up out of her wheelchair...and, she would fall...every single time. She was so far gone she didn’t realize she would fall if she stood. Broken shoulder, broken superorbital ridge (brow ridge), broken arm, various lacerations, scrapes, hematomas. And then it was another trip to the ER. She was actually kicked out of one facility THE NIGHT she returned from the ER. Don’t say it was the facilities. I witnessed her “escapes” multiple times while visiting. She was wiley and quick, and the facility is not allowed to strap her down. The second facility doctor finally said enough and put her on Xanax or maybe Ativan. Kept her seated. The siblings and I all agreed it was for the best. Just heartbreaking.


20 posted on 09/25/2023 1:02:55 PM PDT by moovova ("The NEXT election is the most important election of our lifetimes!“ LOL...)
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