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FDA to probe potentially fatal Alzheimer's drug


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#1 nootropi

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Posted 23 January 2005 - 07:16 PM


Click here

Then click here

[quote name='http://www.nytimes.com/2005/01/22/business/22johnson.html']Regulators are reviewing the safety of the Alzheimer's disease drug Reminyl after data from two clinical trials indicated that people taking the drug had a much higher death rate than those taking a placebo.

The review was announced yesterday by Johnson & Johnson, which said it was in discussions with the Food and Drug Administration and regulators in Europe and Canada.

The trials, which involved about 2,000 patients in 16 countries, were looking at whether Reminyl could be used to treat mild cognitive impairment, a form of memory loss that is often a precursor to Alzheimer's disease. Reminyl is approved in 69 countries as a treatment for mild to moderate Alzheimer's but not for mild cognitive impairment.

In the trials, which lasted two years, 15 patients taking Reminyl died compared with 5 taking the placebo. There were various causes of death but many were from heart attacks and strokes, a company spokeswoman, Carol Goodrich, said.

The announcement comes at a time of heightened concern over the safety of widely used drugs after the withdrawal from the market of Merck's pain reliever, Vioxx, which studies indicated posed an increased risk of heart attacks and strokes.

Johnson & Johnson said that overall number of deaths in the trials was low for the elderly population in the trial and that the incidence of serious side effects was the same for patients getting the drug and the placebo. Also, it said, the investigators in the trials had not thought the drug caused any of the deaths.

The results were reported to regulatory authorities in August and presented at medical conferences, Ms. Goodrich said. Asked why an announcement was being made only now, she said regulators in Europe and Canada had met with the company this week to obtain more data and were preparing to post information about the trials on their Web sites.

Ms. Goodrich said the information would still support the use of the drug for Alzheimer's disease.

A spokeswoman for Health Canada, Carole Saindon, said data was being analyzed and conclusions would be posted when ready. "It's very important that patients don't stop taking the medication without consulting their doctor first," she said.

The announcement comes at a time of heightened concern over the safety of widely used drugs after the withdrawal from the market of Merck's pain reliever, Vioxx, which studies indicated posed an increased risk of heart attacks and strokes.

Johnson & Johnson said that overall number of deaths in the trials was low for the elderly population in the trial and that the incidence of serious side effects was the same for patients getting the drug and the placebo. Also, it said, the investigators in the trials had not thought the drug caused any of the deaths.

The results were reported to regulatory authorities in August and presented at medical conferences, Ms. Goodrich said. Asked why an announcement was being made only now, she said regulators in Europe and Canada had met with the company this week to obtain more data and were preparing to post information about the trials on their Web sites.

Ms. Goodrich said the information would still support the use of the drug for Alzheimer's disease.

A spokeswoman for Health Canada, Carole Saindon, said data was being analyzed and conclusions would be posted when ready. "It's very important that patients don't stop taking the medication without consulting their doctor first," she said.

A spokeswoman for the F.D.A., Kathleen Quinn, said the agency was looking at the data. European regulators could not be reached.

Reminyl was approved on the basis of six-month studies but the mild cognitive impairment trials lasted two years, increasing their chances of detecting side effects. Nevertheless, the Johnson & Johnson analysis said the excess of deaths in the mild cognitive impairment trials was evident by six months, while no such excess was seen in the Alzheimer's trials.

Reminyl, known generically as galantamine, was developed with Shire Pharmaceuticals of Britain. Sales for Johnson & Johnson are estimated at about $200 million a year. The drug, extracted from daffodil bulbs, is a cholinesterase inhibitor, which works by increasing the levels of acetylcholine, a chemical that transmits nerve signals in the brain. Others in this class include Aricept, sold by Pfizer and Eisai, and Exelon from Novartis.

Public Citizen, the watchdog group, recommends against using Reminyl or other drugs in its class, saying they have minimal benefit and the effectiveness and safety of taking them longer than six months is not known, according to Sidney Wolfe, director of health research.

There are no drugs approved for mild cognitive impairment but drug companies are pursuing that condition in hopes of preventing people from sliding into Alzheimer's.[/quote]
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#2 jolly

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Posted 25 January 2005 - 06:49 PM

ps. remynl = galantamine hydrobromine, and is availble OTC in the US. Granted, the only place i now where you can actually buy it over the counter is sherwyns in chicago.


I'm surprized, given it is supposed to help with programmed cell death.

ps. This drug is also where we got the phrase holy moly from, courtesy of the classic epic the oddessy.

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#3 teak

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Posted 27 January 2005 - 02:40 AM

Reminyl is an acetyl-cholinesterase inhibitor, just like Huperzine A (extract of club moss, Huperzia serrata). As I posted in the Huperzine A thread:

http://en.wikipedia....icholinesterase

An anticholinesterase is a chemical that inhibits a cholinesterase enzyme from breaking down acetylcholine, so increasing both the level and duration of action of the neurotransmitter acetylcholine.

Anticholinesterases occur naturally as venoms and poisons, are used as weapons in the form of nerve agents, and are used medicinally to treat diseases such as myasthenia gravis and Alzheimers disease, and as an antidote to anticholinergic poisoning. In myasthenia gravis, they are used to increase neuromuscular transmission.


http://en.wikipedia....lcholinesterase

A cholinesterase inhibitor is known as an anticholinesterase. Because of its essential function, chemicals that interfere with the action of cholinesterase are potent neurotoxins, causing excessive salivation and eye watering in low doses, followed by muscle spasms and ultimately death. Outside of biochemical warfare, anticholinesterases are used are also used in anesthesia or in the treatment of myasthenia gravis, glaucoma and Alzheimer's disease.



#4 jolly

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Posted 27 January 2005 - 07:35 PM

This is true, except beyond being just a ace inhibitor, it also helps to potentiate the nicotinic receptors, as well as indications it helps with cell death.

#5 power.bulls.x

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Posted 15 December 2005 - 07:28 PM

common prices are:

REMINYL*56CPR RIV 4MG € 85.92
REMINYL*56CPR RIV 8MG € 108.07

the 4mg form isnt twice cheaper !
i am juste wodering i will be better for 4mg/day to cute the 8mg into halves. it is cheaper!

[thumb]

EDIT: price doenst seems to drop with the late risvatagime breaktrought

Edited by power.bulls.x, 28 February 2007 - 01:12 AM.


#6 power.bulls.x

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Posted 15 December 2005 - 07:35 PM

DONEPEZIL is a lot more exempive: (i ve heard it has a 70h half life)

ARICEPT*28CPR RIV 10MG € 122.09
ARICEPT*28CPR RIV 5MG € 97.65
MEMAC*28CPR RIV 10MG € 122.09
MEMAC*28CPR RIV 5MG € 97.65

i am never used ARICEPT i am wodering if dosage are the same compared to REMINYL(i take 'mg/day)

#7 xanadu

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Posted 15 December 2005 - 09:03 PM

You should have no problem cutting an 8mg pill in half if you are using 4mg or cutting a 10 for two fives. The drug companies are greedy swine and the drug itself probably costs them under one euro to manufacture. Take advantage of any savings you can.

#8 wannafulfill

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Posted 16 December 2005 - 12:23 AM

I'm all for the investigation, but those numbers mean little with a population so close to death in the first place. I'd doubt there is a statistical difference. Galantamine might not be the best nootropic to take but it doesn't kill you.

#9 catshmat

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Posted 16 December 2005 - 12:36 AM

Is there any reason to take Reminyl over GalantaMind by Life Enhancement? I would be interested to hear about (speculative or substantiative) ideas about the possible causes of these results. If similar results have not been found for Aricept and Donezepil should we focus on nicotinic stimulation as a possible contributor? Is there an specific dose or range of doses that the study participants were using?

#10 liorrh

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Posted 16 December 2005 - 12:37 AM

I'm all for the investigation, but those numbers mean little with a population so close to death in the first place. I'd doubt there is a statistical difference. Galantamine might not be the best nootropic to take but it doesn't kill you.


why isa not the best? people sing its praises.
what is the link between nicotininc receptors and cell death?

#11 wannafulfill

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Posted 16 December 2005 - 01:16 AM

I said that because I don't like its subjective effects. They do not benefit me.

#12 johnmk

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Posted 16 December 2005 - 04:00 AM

What are your subjective effects?

#13 jolly

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Posted 16 December 2005 - 04:41 AM

GalantaMind vs galantamine is really more of personal preference - galantamind adds a bit of b5 and choline.

ps. do be aware that there are two versions of galantamind available, one containing 4mg of galantamine, and the other 8mg.

And remember, it does have the potential to upset your stomach, especially at the higher dose, take it with food.

#14 teak

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Posted 02 January 2006 - 11:23 PM

Noticed this:

http://alzheimers.ab...inyl_trials.htm

April 2005
Two clinical trials have indicated that people taking the Alzheimer's disease drug Reminyl (galantamine) have a much higher death rate than those taking a placebo. The review was announced by Johnson & Johnson who manufacture Reminyl. Johnson and Johnson said that they were in discussions with the Food and Drug Administration and other regulators in Europe and Canada.

The article links to a PDF letter sent by Ortho-McNeil Neurologics (manufacturers of Reminyl) highlighting the issue but stating other studies have not shown the same results. Information about the clinical trials might be listed at clinicalstudyresults.org.

Another article mentions Reminyl was renamed to Razadyne as of 1st July 2005, to avoid confusion with a diabetes medication glimepiride (Amaryl). Supposedly resulted in 2 deaths when Amaryl was given by mistake.

Edited by teak, 03 January 2006 - 02:56 AM.


#15 power.bulls.x

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Posted 03 January 2006 - 08:25 AM

over long periode of use does it reduce receptors ?
Does increasing choline above normale levels over a long periode is free of sides.

i means when you have a lot or too mutch of someting for a long periode of time your receptor are reduced to adjust . How doe it apply to galantamine ?

what drug can increase the number of receptors ? BDNF(inderectly by reboxetine) ? IGF-1 ?

#16 dimjimm

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Posted 03 January 2006 - 07:13 PM

i means when you have a lot or too mutch of someting for a long periode of time your receptor are reduced to adjust .

Exactly. With most Acetylcholinesterase inhibitors the numbers of receptors naturally declines. So you lose some (maybe all) of the gains gotten from the extra Ach.

How does it apply to galantamine ?

Galantamine increases the number of nicotinic receptors so you keep the beneficial effects from increasing Ach.

what drug can increase the number of receptors

IIRC Nefiracetam has some kind of nicotinic effects, dunno if it was the same as Galantamine or not.

BDNF(inderectly by reboxetine) ?

exercise, calorie restriction, omega 3, and some of the new neuropeptides.

#17 dimjimm

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Posted 03 January 2006 - 07:15 PM

My question is...

What doses were used in these studies?

Was it 4-8mg like in Galantamind or the higer 16-20mg doses?

#18 psychenaut

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Posted 05 January 2006 - 04:42 PM

Because I keep getting people asking me about galantamine:

Please read this to understand the facts.

If anybody has updated information, from qualified sources, by all means please post it. Otherwise, let the original headline of this thread serve as a warning for people to do some homework. Let's play our part to have imminst.org serve as a source of objective, factual information.

Save the hysteria for when the facts support it.

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#19 teak

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Posted 05 January 2006 - 05:48 PM

Are there any studies done on healthy individuals? The benefits and safety from such studies are based on patients with medical conditions so already have lower than normal acetylcholine levels. Might not be applicable for healthy individuals with normal acetylcholine levels just looking to improve memory.




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