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Severe cholestatic hepatitis induced by pyritinol


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#1 cesium

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Posted 23 May 2005 - 09:51 PM


http://bmj.bmjjourna...ll/328/7439/572

They suspect it might be caused by a metabolic idiosyncrasy or immunological hypersensitivity, but they also said that this might not be as rare (<2%) as they once thought. Those starting out on pyritinol might want to monitor themselves the first few weeks after supplementing with it for any signs of hepatotoxicity (pruritus, jaundice, ect) until they are sure they aren't sensitive to it.

#2 jeromewilson

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Posted 23 May 2005 - 10:48 PM

Oh strewth, and I was just thinking 'I must get me some of that pyritinol stuff'. I wonder if milk thistle would protect against any adverse effects on the liver.

Does "unexpectedly high in vitro CD4+ T cell responses to the drug were documented" actually mean that they were allergic to it?

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#3 cesium

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Posted 23 May 2005 - 11:13 PM

Either allergy or some metabolic idiosyncrasy. I just started on pyritinol today and intend to keep a close eye on things for the next few weeks just to make sure that I'm not one of those in that particular subgroup who react to it in that way. I used to think it only applied to those who were treating their rheumatoid arthritis with pyritinol, but that is apparently not the case.

#4 jeromewilson

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Posted 23 May 2005 - 11:22 PM

Hmm, well I hope it goes well for you. Do you think you could maybe check in with a progress report sometime? Not just if you turn yellow ;) - it would be good to know what your experience with it is.

Jerome

#5 charisma

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Posted 23 May 2005 - 11:45 PM

Hmm, I was just about to add Pyritinol to my stack too. Now I'm not quite so sure.

#6 cesium

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Posted 24 May 2005 - 12:15 AM

I still am not especially concerned as this reaction still appears to be quite rare. Pyritinol has been around for a long time and the risk appears negligible. Also, as physician commenting on this study noted:

I was surprised to read about the liver toxicity of pyritinol in these 6 patients when 5 of them were taking medicines that are well known to cause toxic hepatitis (paracetamol), cholestatic hepatitis (nitrofurantoin, oral contraceptives, erythromycin) or even acute liver failure (nimesulide). How can one say how much is the effect of these medicines and how much is the effect of pyritinol?



#7 Michael

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Posted 24 May 2005 - 02:28 AM

jeromewilson: Oh strewth, and I was just thinking 'I must get me some of that pyritinol stuff'. I wonder if milk thistle would protect against any adverse effects on the liver.

charisma:Hmm, I was just about to add Pyritinol to my stack too. Now I'm not quite so sure.

I suggest that you guys take a step back and look at the big picture here. I am guessing that none of you have a life-threatening disease for which more conventional therapies have failed leaving pyritinol as your sole hope, but that you are instead essentially healthy life extension and/or nootropic enthusiasts looking to get some kind of brain buzz. However small you rate the risk, is even so small a chance of destroying your chance of reaching actuarial escape velocity (1) a good tradeoff for the miniscule, likely largely placebo-effect-driven benefits you will get from this stuff -- benefits likely minimally distinguishable from the rest of your nootropic stack or even a good mug of java?

Priorities, people! As the study authors noted,

BMJ: the most striking feature in these patients was the severe and prolonged nature of the cholestasis that required admission to hospital in four previously healthy young individuals. The seriousness of this adverse reaction contrasts with the relatively small clinical importance of the problem that led to its prescription. Therefore, the cases reported here justify a reassessment of the risk and benefit of pyritinol.

cesium:  I still am not especially concerned as this reaction still appears to be quite rare. Pyritinol has been around for a long time and the risk appears negligible.

This is the problem with 'natural' or nearly-natural supplements, often sold OTC with little formal drug surveillance: we rarely have any clear idea of their safety profile. As the study authors noted,

BMJ: Ascribing severe adverse reactions to drugs such as pyritinol—generally considered innocuous by patients and doctors—is particularly difficult as a link with such drugs is not usually considered ... Interestingly, the doctors who referred the patients to our unit did not consider pyritinol to be a likely cause of hepatitis, so it is possible that this non-dose dependent drug hepatotoxicity may have been substantially under-reported during these years.

cesium:  Also, as physician commenting on this study noted:

Ioana Vlad:  I was surprised to read about the liver toxicity of pyritinol in these 6 patients when 5 of them were taking medicines that are well known to cause toxic hepatitis (paracetamol), cholestatic hepatitis (nitrofurantoin, oral contraceptives, erythromycin) or even acute liver failure (nimesulide). How can one say how much is the effect of these medicines and how much is the effect of pyritinol?

I would say that, while we can't be certain, the answer is pretty obvious from the case histories:

BMJ:
Case 1—A 23 year old female student complained of nausea, malaise, and jaundice one month after starting pyritinol 600 mg a day for "memory improvement." She had also been taking paracetamol with codeine sporadically for some years because of headache. Discontinuation of pyritinol led to rapid clinical improvement and to normalisation of liver function five months later.

Case 2—An 18 year old female student was prescribed nitrofurantoin 400 mg a day for cystitis and pyritinol 600 mg a day for "memory improvement." Five days later she was admitted to hospital with pruritus and jaundice ... One year earlier she had been taking pyritinol at the same dose for 20 days with no known adverse effects. Improvement of her condition was observed after she stopped taking pyritinol, and liver function returned to normal five months later.

Case 3—A 27 year old woman presented at the out-patient clinic with jaundice and abnormal liver function tests. She had been taking oral contraceptives for three years and had started taking pyritinol 400 mg a day 25 days before presenting at the clinic. Liver function returned to normal more than six months after she stopped taking pyritinol.

Case 4—A 21 year old woman was admitted to hospital with malaise, vomiting, and fever of three days' duration and abnormal results for liver function tests. She had been taking pyritinol 600 mg a day for a month and was also taking nimesulide (one or two pills a month) for dysmenorrhoea. After she stopped taking pyritinol, liver function improved but did not return to normal for nine months.

Case 5—Ten days after starting to take pyritinol 600 mg a day, a 41 year old man was admitted to hospital with nausea, vomiting, jaundice, and abnormal liver function. Complete clinical and biochemical normalisation was seen two months after he stopped taking the drug.

Case 6—A 24 year old woman had nausea, vomiting, abdominal pain, fever, and jaundice 14 days after starting to take pyritinol 400 mg a day for "memory improvement." She had also been taking erythromycin 500 mg every six hours during the previous eight days for a sore throat. Liver function returned to normal within a month. When she inadvertently took pyritinol again six months later, she developed the same symptoms and blood tests gave similar results.

You pays your money and you takes your pick, but in a world of ALCAR, piracetam, pyroglutamate, DMAE, and other nontoxic, well-established nootropics, I can't fathom why a person would take a risk on pyritinol after reading the above report.

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Edited by LifeMirage, 25 May 2005 - 12:36 PM.


#8 scottl

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Posted 24 May 2005 - 06:30 AM

Michael,

If you could "get it" from books/journals/pub med then Nootropi's advise would be as useful as LifeMirage's. However you can't replace clinical experience by extrapolating from however many articles.

(Micheal)
the miniscule, likely largely placebo-effect-driven benefits you will get from this stuff -- benefits likely minimally distinguishable from the rest of your nootropic stack or even a good mug of java?


I have no idea what these comments are based upon, but a search of imminst even yesterday would have yielded:

LlifeMirage 5/23/05
"Centrophenoxine & Pyritinol tend to work best for focus".


Micheal
but in a world of ALCAR, piracetam, pyroglutamate, DMAE, and other nontoxic, well-established nootropics, I can't fathom why a person would take a risk on pyritinol after reading the above report.


Pyritinol IS a well established nootropic, and see above. Or to put it another way, people go into anaphalytic shock and die or almost die all the time from food allergies to peanuts, sheelfish, etc. And truthfully, you can eat a food 50 times and on the 51st go into shock....so no more shrimp or peanuts for you?

LifeMirage has commented on the toxicity within the last month or so. If anyone has additional questions (Eclypse?)...

Edited by scottl, 24 May 2005 - 07:57 AM.


#9 LifeMirage

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Posted 24 May 2005 - 08:01 AM

Michael I suggest to do more research to support your comments, which are clearly not based on the weight of the scientific research done on Pyritinol.


I suggest that you guys take a step back and look at the big picture here. I am guessing that none of you have a life-threatening disease for which more conventional therapies have failed leaving pyritinol as your sole hope,


Pyritinol is a conventional drug that is so safe it is used in children in many countries.

but that you are instead essentially healthy life extension and/or nootropic enthusiasts looking to get some kind of brain buzz. However small you rate the risk, is even so small a chance of destroying your chance of reaching actuarial escape velocity (1) a good tradeoff for the miniscule, likely largely placebo-effect-driven benefits you will get from this stuff -- benefits likely minimally distinguishable from the rest of your nootropic stack or even a good mug of java?


You apparently have no understanding of biochemistry, neurochemistry or most nootropics. The effects of most nootropics have been clearly established as beyond both placebo and coffee. Also they are our only current option to protect our brain to reach actuarial escape velocity.

Priorities, people! As the study authors noted,


They also pointed out these were not healthy people as most of them were on several drugs. And again a few people out of millions count for almost nothing. You have a far greater chance of taking an aspirn pill and dying.

This is the problem with 'natural' or nearly-natural supplements, often sold OTC with little formal drug surveillance: we rarely have any clear idea of their safety profile. As the study authors noted,


Pyritinol has been in use for over 40 years, approved in several countries as a drug. All research shows it is safe. (Case reports mean nothing)

I would say that, while we can't be certain, the answer is pretty obvious from the case histories:


It is quite sad but most laypersons have no idea how to interpret data. Yes the answer is quite obvious studies conducted on kids, adults, healthy and unhealthy have shown Pyritinol is very safe. Only in studies concerning rheumatoid arthritis show a very small risk of side effects that go away when discontinued.

Endpoint: Read the research carefully and made your own decision. But just to note I have personally given Pyritinol to over 1,000 people without any problems and no one have ever died from taking it.


P.S. Thank you scottl

#10 LifeMirage

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Posted 25 May 2005 - 12:36 PM

http://www.imminst.o...=169&t=385&st=0

Case reports are not studies.

Many supplements can cause on adverse reaction in certain people and is best avoided. An example is caffeine which I think is pretty safe but some people have a strong reaction to it. People who have autoimmune conditions may wish to avoid pyritinol as it seems in some people their immune system causes a negative reaction.

In all the Studies conducted it has not been shown to cause or be hard on the liver.

All the reactions seen in case reports would appear to be the immune systems reaction to pyritinol, rather than pyritinol itself.

Also I have never seen anyone post a reaction online, you would think if it would cause a problem people would report it.

Trial and error is a way of life.

So in conclusion the weight of scientific evidence pyritinol is a safe compound but there is a rare chance of having a negative reaction to it (especially if you are taking other drugs with it or have an autoimmune condition). Also I do not take the news of reactions lightly by any means, but as with ANY compound there is always chance of a side effect, but you won't know until you take it.

#11 LifeMirage

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Posted 25 May 2005 - 12:41 PM

Oh strewth, and I was just thinking 'I must get me some of that pyritinol stuff'. I wonder if milk thistle would protect against any adverse effects on the liver


Milk thistle probably won't have much effect as it is the immune system causing the reaction.

#12 wannafulfill

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Posted 25 May 2005 - 05:39 PM

I am curious as to this issue with the immune system. If there is some warning of a slight chance of side effects with pyritinol, would it be for people already with autoimmune disorders, or people who are at an already great risk of developing one.

My entire immediate family has type 1 diabetes. I have lucked out thus far. I was the subject of a few research trials, one of which told me I have a remarkably high level of antibodies against glutamic acid decarboxylase , which are implicated in several autoimmune disorders. I don't suppose anyone would have any reason to avoid pyritinol in this case?

#13 LifeMirage

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Posted 25 May 2005 - 07:50 PM

I am curious as to this issue with the immune system. If there is some warning of a slight chance of side effects with pyritinol, would it be for people already with autoimmune disorders, or people who are at an already great risk of developing one.

My entire immediate family has type 1 diabetes. I have lucked out thus far. I was the subject of a few research trials, one of which told me I have a remarkably high level of antibodies against glutamic acid decarboxylase , which are implicated in several autoimmune disorders. I don't suppose anyone would have any reason to avoid pyritinol in this case?


I did not mean to statement anyone with any autoimmune disorder should avoid it, as it is used to treat them as well. But if you are concerned of the rare chance there may be a problem then avoid it.

#14 AaronCW

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Posted 27 May 2005 - 02:30 AM

To present myself as a case study;
I have been diagnosed with two separate autoimmune diseases, neither of which I have been able to resolve using either conventional or alternative therapies. I have in the past used pyritinol with no problem (a full bottle from Smart Nutrition). On the first experience of taking pyritinol from Axiom biologicals I developed a severe reaction, including nausea, vomiting, and fever. This particular reaction occured several times regardless of dosage. Since then I have had a similar reaction to Smart Nutrition's Piracetam.

note: Disregard last sentence. I meant of course to say Smart Nutrition's pyritinol. The particular bottle of pyritinol from Smart Nutrition which caused a severe reaction has since been used by other individuals with no adverse reactions.

Edited by rasputin, 27 May 2005 - 08:42 PM.


#15 scottl

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Posted 27 May 2005 - 02:45 AM

Rasputin,

1. " two separate autoimmune diseases, neither of which I have been able to resolve using either conventional or alternative therapies."

I may have some ideas, if you are open to it, PM me with details.

2. As I said above, your experience is not uncommon--it happens everyday (not the 2 autoimune diseases part):

"Or to put it another way, people go into anaphalytic shock and die or almost die all the time from food allergies to peanuts, shellfish, etc. And truthfully, you can eat a food 50 times and on the 51st go into shock...."

but what take home message are you suggesting from your experience?

Edited by scottl, 27 May 2005 - 03:09 AM.


#16 AaronCW

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Posted 27 May 2005 - 08:45 PM

Scottl,

I am merely presenting myself as a case study for those interested. I have not ventured to explore any reasoning behind why the reaction occurred in response to Axioms product after I had previously had no reaction to Smart N. pyritinol, or why it still occurs now using product I had previously safely taken. Contamination is certainly a possibility.

None of the case studies which I have encountered seem to correlate very well with my experience. The reaction that I have occurs within an hour of taking even a 200mg dose, and consists of vomiting, nausea, and fever.

I still very much have an interest in pyritinol, as it is one of the most interesting of all nootropics. It was very effective for me personally while I was having no reaction to it. I do not intend to discourage use of pyritinol, especially considering that the majority of those instances, however often they occur, seem to allow for enough time to moniter any adverse reactions via blood work.

Rasputin

#17 charisma

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Posted 28 May 2005 - 12:24 AM

I had a similar reaction to some medication that I used to take with no problem Rasputin. I was taking Percocet for a pulled back muscle and everything was fine, then a few months later I hurt my back again and went on the same thing, except now I'd discovered that I had the same symptoms you just described.

It turned out that it was caused by some antibiotics I took between the two incidents. The antibiotics killed the good bacteria in my digestive system along with the bad, and so I had an adverse reaction to certain kinds of food and medication. The doctor said it was Candida overgrowth syndrome. I'm better now but I still wrestle with it a bit. I took probiotics for it, like lactobacillus to replace the good bacteria. It took a little while but it worked.

It's a long shot that you have something similar but you might do a google search for candida overgrowth syndrome and see if any of your symptoms match up with your immune system problems.

#18 LifeMirage

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Posted 28 May 2005 - 10:10 AM

Scottl,

I am merely presenting myself as a case study for those interested. I have not ventured to explore any reasoning behind why the reaction occurred in response to Axioms product after I had previously had no reaction to Smart N. pyritinol, or why it still occurs now using product I had previously safely taken. Contamination is certainly a possibility.

None of the case studies which I have encountered seem to correlate very well with my experience. The reaction that I have occurs within an hour of taking even a 200mg dose, and consists of vomiting, nausea, and fever.

I still very much have an interest in pyritinol, as it is one of the most interesting of all nootropics. It was very effective for me personally while I was having no reaction to it. I do not intend to discourage use of pyritinol, especially considering that the majority of those instances, however often they occur, seem to allow for enough time to moniter any adverse reactions via blood work.

Rasputin


Is there any other food or supplement you have taken that has caused either a similar or negative reaction?

#19 AaronCW

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Posted 28 May 2005 - 07:50 PM

Is there any other food or supplement you have taken that has caused either a similar or negative reaction?

I have never experienced a similar reaction from foods, supplements, or drugs.

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#20 LifeMirage

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Posted 01 June 2005 - 07:15 AM

QUOTE 
Is there any other food or supplement you have taken that has caused either a similar or negative reaction?

I have never experienced a similar reaction from foods, supplements, or drugs.


What about a negative reaction?


I have been diagnosed with two separate autoimmune diseases



What do you have and how do the symptoms present themselves?




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