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duck

Preservatives Added to Insulin

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I know these are controversial topics, but the crowd here seems to keep an even-keel and at the same time debate some tough topics:

 

To that end: does anyone know if the the "m-cresol" and phenols added to our insulins today are "safe" for us? Looking at the insert that comes out of my NovoLog box, there is 1.72 mg/mL metacresol in NovoLog, and 1.50 mg/mL of phenol.

 

Oddly enough, I only find two hits on these forusm about "cresol", but I was sure it had been brought up before...Google is my friend:

 

m-cresol / other insulin ingredients [Archive] - Diabetes Forums

 

Googling "m-cresol" will scare you, so wade in carefully. But what are the longterm effects of pumping/injecting this stuff into our interstitial tissues? And is there a way to get insulin without this stuff as an ingredient?

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Duck, I am looking into this myself a the moment, having concluded from on-off testing that Novorapid, my best choice insulin, seems to be causing a bit of asthma and fatigue. There sure is a lot of fear mongering out there as you rightly point out, what is not clear is the real risks or problems of long term use that might be associated with these additives. I have been looking more into the potential sensitivity or allergy problem.

 

I did see a particularly negative blog about m-cresol, pointing to warnings of it as an almost carcinogenic which as I say without a high level of knowledge, strikes me as dramatic speculation at the levels we take. But it claimed that apidra has a lot more, which is interesting to me as I felt extremely sick on Apidra and barely got through a week. If I have a sensitivity to m-cresol, this might be an explanation.

 

I am guessing (and hoping) that the main problems are not so much long term poisoning/underlying issues, but sensitivities to one or the other, and what to do about it, I do not know as every insulin available to me has these additives - and that included bovine hypurin, before anyone jumps in saying this is another evil of synthetics and not animal insulins.

 

I am doing some more looking around, and I am also going to ask around about allergy testing for the components of insulin. I do know there is an Novo Nordisk allergy kit used to test for allergies, but whether this is an expensive, highly clinical type solution, I do not know but am expecting. My interest will be in testing other than that, phenol at least may have other methods to determine reactions. I will post if I get anywhere with that.

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Subby, I would be very curious to know if you find anything out. From what I can tell, m-cresol and phenol have a long history of getting added to insulin, back to the 1970's...Apparently, they are responsible for that intense "band-aid" smell that insulin has. So the safety of the additives seems to be well-established.

 

Still, I too wonder about what the options are if somehow it were determined that you had a sensitivity or outright allergy to any of these things...and I have always complained about being tired since I was diagnosed with this disease...Maybe I don't have a full-blown sensitivity to something in insulin, but *just enough* to make me slightly sick.

 

I know, I know. Pure speculation. But it would be nice to have options to experiment with and perhaps come up with a better treatment regimen.

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I am currently on novomix 30, which I dont think is available in the US ,it has a list of some 20 ingrediants some of which does not sound very pleasant. However the product leaflet states that they are inactive!

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when the ingredients sy that the are inactive that means it is not the stuff thats works in your body. It is just the medium that the insulin/ medicine is carried in

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What matters is the dose and not whether the chemical itself is toxic. ALL chemicals are toxic in sufficient quantities - there have more than a few deaths in ecstacy users from drinking too much water.

 

All chemicals (including drugs) have a dose response curve. The curve is typically "S" shaped. What matters in toxicology is the threshold - i.e. the point at which the chemical starts to do harm.

 

Our bodies tolerate small amounts of toxins and carcinogens all the time. These chemicals are either excreted in the kidneys, or turned into less-toxic products by the liver.

 

Insulin has preservatives added to it, because to the average microrganism insulin is a protein energy shake. Every time you push a needle through the rubber cap on the bottle you will also push some bacteria into the bottle. The preservatives are there to prevent those bacteria from multiplying.

 

In the case of insulin what matters is the concentration - if the concentrations of phenol were the same as in fence paint, then yeah I think we might just have a toxicity problem.

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As Subby points out the issue with the preservatives added to insulin is the development of allergies to the product. Once the body has become sensitised to an allergen, then a reaction can occur at very low concentrations. In most cases the person will get a rash after taking the medication - you will find this warning on your medication description. In very severe cases the person can suffer from anaphylactic shock.

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These preservatives arenot safe, I have been a type 1 for 57 years and developed an inflamatory problem that could not be identified, seems to be my body's reaction to the preservatives, they are petroleum solvents aka benzene and tolulene check out the haz mat sheets. spoke to our local office of the fda and they told me these chemicals have an accululative effect, there is no way to rid the body of the disasterous effects of these chemicals. Local poison control didn't know what to do. Spoke to a chemical engineer after he got over the shock, told me there was no way to rid the body, and a constant influx of the chemicals either by injection or infusion will continue to destroy the tissues. As it is I am having a problem looking for new infusion sights or injection sites as the tissues or so damaged the insulin does not absorb correctly, sometimes I have to overdose just to get the right amount, i lose about 25% in the damaged tissues.

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These preservatives are not safe, I have been a type 1 for 57 years and developed an inflammatory problem that could not be identified, seems to be my body's reaction to the preservatives, they are petroleum solvents aka benzene and toluene check out the haz mat sheets. spoke to our local office of the fda and they told me these chemicals have an accululative effect, there is no way to rid the body of the disasterous effects of these chemicals. Local poison control didn't know what to do. Spoke to a chemical engineer after he got over the shock, told me there was no way to rid the body, and a constant influx of the chemicals either by injection or infusion will continue to destroy the tissues. As it is I am having a problem looking for new infusion sights or injection sites as the tissues or so damaged the insulin does not absorb correctly, sometimes I have to overdose just to get the right amount, i lose about 25% in the damaged tissues.

Are you saying they are putting benzene and toluene in insulin because that would *really* surprise me. Those substances are highly dangerous in even small quantities and I cannot see them ever getting passed for inclusion in insulin. If you are talking about related chemicals then it is pretty meaningless because toxicity does not follow, there are a lot of really nasty chemicals very close to salt for example.

 

Damage to tissue is caused by trauma, basically repeatedly piercing the flesh which leads to scarring. Scar tissue is much denser and doesn't absorb insulin in the same way that subcutaneous fat does. You have had this for a long time and I am sure you know this but I thought I would mention it anyway. To an extent this can be fixed with laser surgery that breaks up the scar tissue.

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No, e.coli is a bacteria that is found in the gut of every single mammal. It is also a beneficial bacteria to have inside you as it produces vitamin K and prevents infection by other, malignant bacteria. There are a variety of different strains, most of which are completely harmless, some of which cause food poisoning.

 

Synthetic insulin is produced by genetically modified e.coli. All cells contain DNA, which is essentially a recipe for producing proteins. In modified e.coli, all the DNA that is normally present is removed and is replaced with the recipe for insulin. So the cell then produces insulin and no other proteins. The cell is basically a bag with a factory in it and there is no risk of creating something dangerous or infectious because the DNA recipe for creating something bad is entirely replaced wit the insulin recipe.

 

E.coli has nothing whatsoever to do with MRSA, which is another bacteria, rather than a fungus. It also has nothing to do with mucormycosis.

 

With the greatest respect, if people are going to have a sensible debate then please actually understand the science behind what you are discussing. Posting points of view that are based on falsehoods isn't helpful.

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Well anyway, it's funny this thread came up as I plan to get a sensitivity test for phenol done in the near future. Thanks to MCS I've got a send-away lab that will do this. If I remember, and if I find out something suggestive, I will post what I find out here.

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Tribbles You need to check out this information for your self. Talk to a compounding pharmacist, ask them what preservative they use in insulin. I went looking for a reason as to why i was having such a bad reaction(large immediate bruise) every time i used this certain insulin no matter where i injected. Anyway as i said before you need to check it out for yourself. p.s. i'm not having laser surgery on my entire body.

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Tribbles You need to check out this information for your self. Talk to a compounding pharmacist, ask them what preservative they use in insulin. I went looking for a reason as to why i was having such a bad reaction(large immediate bruise) every time i used this certain insulin no matter where i injected. Anyway as i said before you need to check it out for yourself. p.s. i'm not having laser surgery on my entire body.

I looked into this and all the insulins, including porcine, that I could get data on contain metacresol. Both Hypurin and Hypourin porcine insulins contain phenol, as does NPH. These preservatives are not new. None of them used benzene or toluene. Insulin needs preservatives for the reasons given in the earlier posts.

 

Preservatives by their nature are toxic or they aren't preservatives! Of course toxicity varies from preservative to preservative, but when you are dealing with small quantities like drug vials you need something that is toxic in small volumes or it isn't going to work (you can't have a gallon of preservative for 100ml of insulin). The key is to find the minimal amount of preservative that does the job but doesn't hurt the patient, which arguably they have done or there would be a lot of dead diabetics! That doesn't mean some people, by the sounds of it you are one of them, won't get an allergic reaction to some of them.

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