Adthyza... An affordable NDT?: Hello - I recently... - Thyroid UK

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Adthyza... An affordable NDT?

140 Replies

Hello - I recently came across a post in another forum about something called Adthyza. It's a new NDT on the market and supposedly very affordable. I was wondering if anyone knew of this medication, has any experience with it? Many thanks!

EDIT: I don’t know a lot about NDTs but I do know that ALL NDTs are “not FDA approved” so I wouldn’t give that part much credence.

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140 Replies
Alanna012 profile image
Alanna012

I haven't heard of it. I have to ask, is it a real NDT or a glandular marketed as an NDT? (Sorry to be rude).

Josephineinamachine profile image
Josephineinamachine in reply to Alanna012

I never quite understand the difference but I found this?

dailymed.nlm.nih.gov/dailym...

Alanna012 profile image
Alanna012 in reply to Josephineinamachine

Thank you!

It looks like it's a proper standardized NDT from what I can see on the link you've provided!

Fabulous!

Josephineinamachine profile image
Josephineinamachine in reply to Alanna012

😊

RedApple profile image
RedAppleAdministrator in reply to Josephineinamachine

According to the info on that link:

Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA

in reply to RedApple

do they not say that about all NDT?

RedApple profile image
RedAppleAdministrator in reply to

I haven't checked that site for any other NDTs, but as this is a new product I'm a lot more wary! Armour has been around for many decades.

helvella profile image
helvellaAdministratorThyroid UK in reply to

They do! Including Armour.

radd profile image
radd in reply to

Yes! This new one also has the additions of mannitol and silicon dioxide over Armour.

helvella profile image
helvellaAdministratorThyroid UK in reply to radd

But I've never been sure of the ingredients of Opadry White which is used in Armour.

radd profile image
radd in reply to helvella

Yes, agree. some sites include it and others don't 🤷‍♀️.

TiggerMe profile image
TiggerMe

Looks like it has jumped through the hoops... they should perhaps call it combined rather than natural with all the excipients... not sure if American pigs have a well regulated life?

drugs.com/pro/adthyza.html

I do like the idea of 'natural' but it isn't really is it?

Hmmm... mannitol 😔
Jaydee1507 profile image
Jaydee1507Administrator in reply to TiggerMe

Eww, contains Mannitol?! Barely 'natural'!

helvella profile image
helvellaAdministratorThyroid UK in reply to TiggerMe

It is manufactured from porcine thyroid.

If you just treat the word levothyroxine as meaning T4, and liothyronine as meaning T3, it is quite sensible.

TiggerMe profile image
TiggerMe in reply to helvella

Sorry 🍄 you have lost me?

I'm not sure what percentage of natural needs to remain to keep the tag?

Or how many things can you add to a natural item before it becomes unnatural?

helvella profile image
helvellaAdministratorThyroid UK in reply to TiggerMe

Well, ALL desiccated thyroid products add things like sugars, magnesium stearate, etc.

So I view this as pretty similar to Armour, Acella, Erfa, etc.

They are not saying they are adding T4 and T3.

in reply to helvella

all NDT products say this apparently just for simplicity but the t4, t3, t2 and t1 in ndt is apparently attached to thyroglobulin which affects the way it’s metabolised. I need to find the source but I’ll do it tomorrow 😴

helvella profile image
helvellaAdministratorThyroid UK in reply to

Yes - not saying it is handled in exactly the same way by our bodies.

(A subject that really should have been researched in detail many, many years ago.)

Though I am not convinced any T2 or T1 that might be present has any impact at all.

(There is a greater tendency to say things about uncertain T2 and T1 than MIT and DIT which are likely to be present in higher quantities!)

waveylines profile image
waveylines in reply to helvella

I don't understand all the debate over natural! NDT works different to Liothyronine & Levothyrorine. It is metabolised more slowly as it has a slower uptake release process. For some of us like me that's exactly what we need. For others it not. The only natural thing about ndt is that it is made from dessicated thyroid extract but like all serious hormone replacements it has fillers and it has to meet set standards. The fillers of ndt are no better than what is put in synthetic levothyroine & liothyroinine. Then it becomes a question of what fillers don't cause a reaction...we are all different. These are the two big reasons why people prefer different brand of ndt is likely down to fillers and Erfa has a slightly different active content The difference in the slower release and uptake is probably why people have different preferences between liothyroinine/levothyrocine combination & ndt. And some people need a different ratio of T3/T4 to what is in ndt.

Love Diogenes research on this. Explained so much. So when people say there's really no difference between them....there is!!

As for T1 & T2 the researchers out there are exploring that....and T1 & T2 does have a role...but precisely what is still being explored. So the jury is out.

For me ndt gives me an even consistent experience & Diogenes has explained why. Nothing will convince me to switch back.....I need the slower uptake/ longer release it offers. We are all different. Hurray for diversity and choice!

And if this is a new bona fido ndt in the market then I say Hurray!!! About time.

helvella profile image
helvellaAdministratorThyroid UK in reply to waveylines

I agree.

What matters is simply what works best.

From very early days, I've been convinced that our differences are profound.

I'm very much of the belief that T2 is an important part of how our bodies work. My questioning is whether we can reasonably hold up any T2 and T1 content of desiccated thyroid as being important? Discuss it and hypothesise by all means. But we need decent proof to get further.

I hope this new product provides competition to Armour. And establishes a good reputation. And becomes widely available - including to those who do not live in the USA - at a decent price!

But it concerns me that it will be swept up with the FDA's insistence that desiccated thyroid need to be treated as biologics.

waveylines profile image
waveylines in reply to helvella

Well said Helevella. And the myth of synthectic levo/lio combination is the SAME as a ndt needs busting too. It's not! I totally agree with the T1/2 debate the research needs to discover more. Who knows whether it contributes to the effects efficacy process of treatment. I'd like to kiss Diogenes toes though for the research explaing the uptake release differences. That explains why the synthectics worked but not well for me! Diversity is what is needed we are all different. Shame the NHS has gone down the opposite route & is increasingly limiting prescibing options. Lol....

FancyPants54 profile image
FancyPants54 in reply to waveylines

Can you point me at Diogenes research on the different uptakes of the 2 types of medication please? I would like to read that.

TiggerMe profile image
TiggerMe in reply to FancyPants54

healthunlocked.com/thyroidu...

waveylines profile image
waveylines in reply to TiggerMe

Thanks Eeyore & thanks to you for telling me about it. I had misses the original post. You are a star!! 🥳💕

Litatamon profile image
Litatamon in reply to helvella

Any insight whether T1 or T2 is good for the eyes in any manner?

On Thyroid S out of the blue I noticed that my eyesight was improving. I went through any other supplements I was taking and I had been taking them too long to be that. And I honestly left in my head.

I had to make an abrupt change off Thyroid S (taken by border agent) and am on Synthroid/Cytomel & I just realized that my eyesight has been faltering back to where it was before.

in reply to waveylines

I totally agree, it’s immaterial. I don’t take NDT because it has X fillers or because it is of a natural origin, I take it because it makes me feel better than synthetics. If synthetics made me feel better, I’d take those. If eating the sole of a motorway workman’s boot made me feel better… I’d also take that.

waveylines this is the post I think that helps back up what you’re saying -

healthunlocked.com/thyroidu...

Brightness14 profile image
Brightness14 in reply to

Exactly, well put.

helvella profile image
helvellaAdministratorThyroid UK in reply to

That boot sole might be very useful!

Stockholm tar (and similar) have been used for numerous conditions. These include many skin issues and as an expectorant.

Seems mainly confined to horses these days due to concerns that it might be carcinogenic.

in reply to helvella

your knowledge knows no bounds! I wish you were making my NDT helvella !

waveylines profile image
waveylines in reply to helvella

🤣😄😊 Brill! Will start saving them!

Alanna012 profile image
Alanna012 in reply to helvella

Oh Helvella, only you could come up with a list of remedial uses for boot sole and road tar!😄. Come the Zombie Apocalypse, I want to be on your team! 😂😂

DippyDame profile image
DippyDame in reply to helvella

My father had a skin condition for which, in the early1950s, he was prescribed an ointment containing tar. That was from the consultant in the hospital where he spent weeks as a patient...bandaged like a mummy. I remember visiting him with my mother. The pharmacists hated having to mix it!

Turned out it was a severe allergy to a plant.....can't remember which one.

Talking of horses my uncle used a product called Aintree Liniment on their tired muscles.....and for my Granny's arthritis!!

She swore he was better than any doctor!!

But, like Ronnie Corbett....."I digress"

waveylines profile image
waveylines in reply to

Thankyou & well said!!!

waveylines profile image
waveylines in reply to

Thank you. I've saved....shall print, emboss and frame.....maybe several so can hand out as 'presents' for doubting medics as I sadly come across them!!! There's probably a warning on my notes....don't mind .. it may say " beware of the patient (dog). She bites." 🤣 so long as it keeps them at bay!! 😄

in reply to waveylines

😂😂😂

FancyPants54 profile image
FancyPants54 in reply to waveylines

I so agree with you about the slower uptake. Liothyronine is too immediate and punchy for me I think. This last week I added 2.5 of it to my dosing at bedtime because I was sleeping poorly. For the first few days it helped certainly. But last night was not good and I feel rubbish this morning, hyped somehow. That extra is going to have to come out again.

Noelnoel profile image
Noelnoel in reply to helvella

Ancestral and Nxgen comprise of bovine/porcine gland and liver. Metavive has rice bran and nucleotides

The capsules are some kind of cellulose but I always just tip the contents into my mouth. Swallow enough capsules already with all the supplements

Cornwaller profile image
Cornwaller in reply to TiggerMe

Whether something is "natural" or "unnatural" is difficult to define and most likely irrelevant. For example freezing to death is most probably quite natural whilst central heating unnatural. A more helpful criteria might be if something is, on balance, good for your well being.

TiggerMe profile image
TiggerMe in reply to Cornwaller

An odd example?

Isn't it more like comparing a sausage to a vegan sausage 🤣

I mean comparable to the concoctions in Levo or Lio tablets, they all seem to add something unnatural it's then a question of what you can tolerate along with the bit that you need

radd profile image
radd in reply to TiggerMe

Except for WP Thyroid by RCL Labs. NDT only had added Inulin and Medium Chain Triglycerides. Then they stopped making it ☹️

TiggerMe profile image
TiggerMe in reply to radd

So it is quite possible to make it without the other nasties, I wonder why they are there then?

radd profile image
radd in reply to TiggerMe

Absolutely!

waveylines profile image
waveylines in reply to TiggerMe

Cost? Cheaper?

BirkiNAsa profile image
BirkiNAsa in reply to waveylines

About $40 cheaper than Armour for a month's supply in the U.S.

helvella profile image
helvellaAdministratorThyroid UK in reply to TiggerMe

There are many reasons for excipients. The standard groupings are listed below. But individual excipients can perform multiple roles.

They are not all "nasties". For example, it is hard to claim that water is a nasty! (That is, good clean and purified water.)

If I were formulating a medicine, I would certainly look at existing excipients because so much is know about them. They are available. And only later look at other substances if there was some pressing reason.

But this approach is also likely to end up with many medicines containing a particular active ingredient ending up with similar excipients. Thus making it difficult to avoid things like magnesium stearate, some form of sugar/sugar alcohol (sugar, glucose, sorbital, mannitol, lactose, etc.), and various cellulose derivatives.

In the case of WP Thyroid, it is clear that RLC wanted to provide a product which addressed most customer requirements in terms of being at least lactose-free and corn-free, and avoiding any that have known issues.

It is interesting that there seems to have been a widespread process of adding certification for all animal-derived ingredients with regards to BSE (and similar diseases). Either they provide a certificate showing adherence to standards, or declare that their product does not contain any relevant substances.

(I suspect that many big companies are moving away from animal sources where possible. Mannitol being one example - though from the manufacturers' point of view it has several advantages over lactose despite being more costly.)

Classes of Excipients

• Adjuvants

• Antiadherents

• Binders

• Coatings

• Colours

• Disintegrants

• Flavours

• Glidants

• Lubricants

• Preservatives

• Sorbents

• Sweeteners

• Vehicles

TiggerMe profile image
TiggerMe in reply to helvella

I wonder if anyone has ever bought a pig thyroid and popped it in a food dehydrator to experiment with? I wonder how they check the strength?... I hear they do this with placentas 😬

helvella profile image
helvellaAdministratorThyroid UK in reply to TiggerMe

It has been discussed several times here!

It is illegal to supply thyroid glands, I believe. However - ignoring any and all legal issues, dosing would be next to impossible to manage.

TiggerMe profile image
TiggerMe in reply to helvella

How can it be illegal? Did anyone admit to trying?

helvella profile image
helvellaAdministratorThyroid UK in reply to TiggerMe

First, there are laws concerning animal welfare which probably mean that all pigs would have to go through official slaughterhouses hence come under their regulations.

There are many laws concerning butchery and supply - such as those which are intended to prevent BSE and similar.

in reply to TiggerMe

I remember a whole thread about this actually... Someone could "get hold" of lambs thyroids, I think it was.

TiggerMe profile image
TiggerMe in reply to

Eww😬or even Ewe... not a fan... they don't seem to feature in large scale products so maybe too variable

in reply to TiggerMe

I can get hold of plenty of deer thyroid very easily and asked once if there was much use in that, but as Helvella says dosing might be too hard. Before NDT was standardised, sheep thyroid sandwiches were the classic treatment for hypothyroidism and worked much better than the mess we are all navigating these days 🙃

radd profile image
radd in reply to

Treatment for myxoedema circa 1891: One sheep's thyroid lobe per week. 

- Remove the sheep's thyroid gland lobe asap after slaughter. 

- Cut off fat and connective tissue. 

- Chop up gland and soak in glycerine and carbolic acid for 24 hours. 

- Empty mixture in to a handkerchief and screw up to remove a 'turbid pink liquid' that will keep fresh for a week and must be administered in two equal sized injections within the week. 

ncbi.nlm.nih.gov/pmc/articl...

😳🤮

in reply to radd

😂😂😂 I definitely do that if I was guaranteed wellness! Mind you… I’ve done so much ridiculous stuff at this stage to try and get better my bar is extremely low 🫣

TiggerMe profile image
TiggerMe in reply to radd

🤢

Josephineinamachine profile image
Josephineinamachine in reply to radd

🤢

radd profile image
radd in reply to Josephineinamachine

🤣.

So glad it's the 21C!

Josephineinamachine profile image
Josephineinamachine in reply to radd

me too!! Phew! 🤣

helvella profile image
helvellaAdministratorThyroid UK in reply to radd

They didn't even specify "clean handkerchief"!

radd profile image
radd in reply to helvella

🤣

waveylines profile image
waveylines in reply to TiggerMe

Interesting idea.....back in the day didnt they used to chop them up & eat them or am I thinking of PA & chopping livers up for b12 😳🤔 Had to be eaten raw.

nightingale-56 profile image
nightingale-56 in reply to radd

WP worked perfectly for me, with my Endocrinologist remarking to GP how stable I was on it, and with everything in range. Other bloods than Thyroid bloods were also in a much better place.

waveylines My Mum had to eat raw Liver when she was expecting me.

radd profile image
radd in reply to nightingale-56

Not only did it work better but t’was a lot cheaper than the Armour and Efra of today!

nightingale-56 profile image
nightingale-56 in reply to radd

I can't take Armour or Erfa because of all they have in them other than main ingredient.

radd profile image
radd in reply to nightingale-56

nightingale-56,

Tis a vicious circle.

'Enough' thyroid and sex/adrenal hormone are required to regulate the immune system but because many members don't, they often can not tolerate the 'extras' added to their thyroid hormone meds!

nightingale-56 profile image
nightingale-56 in reply to radd

How right you are radd . You find one that is suitable for you and they then go and change something about it. The first lot of this current prescription was fine, although dosage was hard to define. l ,5 grains being not enough and 1.75 grains being slightly too much. As it is in a capsule with NDT and olive oil inside, I can't cut anything. It is the capsule that has changed things for me. Oh well, back to the drawing board!

in reply to nightingale-56

I used to eat raw liver when I was carnivore. I developed quite a good hack of cutting it up, freezing it and then swallowing it as supplement-sized pieces every day.

radd profile image
radd in reply to

dfc,

I used to eat raw eggs (when I was young) but raw liver!?

Just don't tell me it was with some fava beans and a nice Chianti 🤣 🤣🤣

in reply to radd

Honestly Radd... That's one of the tame things I've done!

nightingale-56 profile image
nightingale-56 in reply to

I think I'd prefer pennyannie 's way of blitzing chicken livers with some mayonnaise, and having a teaspoonful each day!

pennyannie profile image
pennyannie in reply to nightingale-56

News flash -

Asda had no physical stock this week though a full section last week - and the website no longer shows these little frozen tubs of chicken livers.

I've found a similar product on the Waitrose website so looks like we have another option for the time being and it's a little cheaper - dogs love it according to one feedback comment !!

Hey Ho -

Woof woof !!

Lalatoot profile image
Lalatoot in reply to pennyannie

Unless you live 200 miles from the nearest Waitrose like I do!

pennyannie profile image
pennyannie in reply to Lalatoot

Ah, I'm sorry - it's not convenient for me - more like 12 miles rather than 200 :

Maybe check out Pet Stores !!

Lalatoot profile image
Lalatoot in reply to pennyannie

The benefits of living in a remote part of Scotland are many but we do rely on local produce and internet shopping.

humanbean profile image
humanbean in reply to pennyannie

Tesco is selling fresh chicken livers - reviews vary enormously from 1 to 5 stars :

tesco.com/groceries/en-GB/p...

pennyannie profile image
pennyannie in reply to humanbean

Thank you -

I was searching for the like for like frozen tubs -

but needs must - I'll swing round there another day and take a look !!

pennyannie profile image
pennyannie in reply to nightingale-56

Seems I need to eat my words as it appears Asda has reinstated the chicken livers :

I've been twice to Waitrose 2 weeks apart and most of the freezers are out of action and there isn't even any ice cream - 2 weeks trading with about 50% of their floor space standing empty - lunacy ?

So, next week I'm turning right and driving to Asda and hope the website is correct.

 Lalatoot

Alanna012 profile image
Alanna012

Wasn't Nature Thyroid (may it forever rest in blessed peace) derived from the same American USP too? Isn't Armour? I know NP is european based.

But mannitol....

helvella profile image
helvellaAdministratorThyroid UK in reply to Alanna012

Nature-Throid used to be made from the same Thyroid USP that was also supplied by a US company to the makers of Armour.

But when that company was bought up by the makers of Armour, RLC went off to source their own. (Rather than be at the mercy of Armour!)

radd profile image
radd in reply to helvella

And made WPThyroid which I loved and which then went kaput! 😔

waveylines profile image
waveylines in reply to Alanna012

Ah but it's not just the active ingredients that counts. A pharmacist said it is the expedients, how the tablet is compressed & how hard and the coating they put on tablets.....all these factors can affect breakdown of tablet absorption & uptake of the active ingredients. He didn't tell me which combination was the best though. 😥

Alanna012 profile image
Alanna012 in reply to waveylines

Thank you for explaining, I always wonder how the addition of a couple expedients can make such a huge difference, but clearly it can!

helvella profile image
helvellaAdministratorThyroid UK

I might have missed it but does it actually say where the thyroid powder comes from?

Thyroid USP is a standard - not a description of where it comes from. :-)

TiggerMe profile image
TiggerMe in reply to helvella

Not that I could find.... just an assumption based on a Bee Gee's song 'MA' 🤣

I lost interest once I saw the ingredients

BirkiNAsa profile image
BirkiNAsa in reply to helvella

The AdThyza powder comes from Denmark. The company that supplies it is BioFac.

helvella profile image
helvellaAdministratorThyroid UK in reply to BirkiNAsa

Thank you.

This is the first product I've seen made from their Thyroid USP powder.

How did you manage to find that out?

BirkiNAsa profile image
BirkiNAsa in reply to helvella

Info from AdThyza directly.

helvella profile image
helvellaAdministratorThyroid UK in reply to BirkiNAsa

Thank you.

helvella profile image
helvellaAdministratorThyroid UK in reply to BirkiNAsa

I meant to say, other than possibly supplying the small scale compounders in Denmark, I've never identified where BioFac's thyroid powder went. Been on their website for many years - but not identifying customers by country or company.

BirkiNAsa profile image
BirkiNAsa in reply to helvella

My compounding pharmacy used Medisca during the shortages. I was not happy with the product. Now using PCCA. I've talked at length with PCCA who was happy to answer most of my questions, save one. They would not reveal their raw material source. I've just recently posed the thyroglobulin potential removal question to them. Let's see if they answer.

RedApple profile image
RedAppleAdministrator

Looks to me as if it's just a 'compounded' NDT, rather than the long time branded NDTs we're all familiar with. azurity.com/about-us/

Alanna012 profile image
Alanna012 in reply to RedApple

Oh bummer...😥

helvella profile image
helvellaAdministratorThyroid UK in reply to RedApple

I think that you are very close to an explanation of what it is!

One seemingly plausible explanation follows:

During the great shortage of desiccated thyroid a few years ago - when it became almost totally unavailable in the USA - many turned to compounding pharmacies. There seemed to be plenty of Thyroid USP (desiccated thyroid powder) available.

However, the compounding pharmacies operated beyond their licences. They were fine to make up some capsules for an individual patient. But they actually became small-scale manufacturers. They would operate small-scale production runs - for which they were not licensed.

Many patients reported poor results and there were suspicions some capsules were actually synthetic T4 and T3 in standard desiccated thyroid proportions. (Which is outright fraud.)

More recently, the FDA has banned all production of desiccated thyroid by compounding pharmacies.

My suspicion is this company has set up an official small-scale production facility and had it approved. They will be in a position to supply compounding pharmacies with ready-made product.

This says nothing at all about the quality of the product. But it might imply restricted availability - possibly only through the company's own sales scheme but possibly also via compounding pharmacies.

radd profile image
radd in reply to helvella

hel,

It might have already been posted by now but just seen Adthyzatm is an actual NDT available in the usual 1/4, 1/2, 1, 2 grains. Available in America and just a bit cheaper than Armour.

BirkiNAsa profile image
BirkiNAsa in reply to helvella

Compounding pharmacy suppliers and, as such, compounding pharmacies are once again supplying porcine thyroid. But, please see my question above. Is this a thyroglobulinless extract? Or whole gland. I've ordered some and just received it. Time will tell.

helvella profile image
helvellaAdministratorThyroid UK in reply to BirkiNAsa

On the basis that potency and active ingredient (Thyroid USP) are the same as Armour Thyroid, I'd be amazed if it weren't the same regarding thyroglobulin.

BirkiNAsa profile image
BirkiNAsa in reply to helvella

Referencing my earlier comment, here's what I suspect. Allergan will not say where their raw material is coming from. A company that also supplies raw material to compounding pharmacies, Medisca, has both announced a "new extraction technique" and a partnership with Abbott Labs, as of about mid-2021. Note that Medisca gets their material from Sichuan Deebio, a Chinese manufacturer. Besides the worry that the quality and oversight of the Chinese pharmaceutical industry is notoriously bad, "extraction" involves a solvent exchange, which shouldn't be necessary; only freeze-drying, powdering, standardizing, etc. With all the FDA fuss about thyroglobulin being a "biologic", am wondering if we're getting a T4/T3 "extract" and not simple dessicated whole gland. The medicine no longer has a porkey smell. The industry now uses the terminology "NTE" as opposed to "NDT"; and again a recent lab evaluation of mine had TGB flagged low, which shouldn't be on NDT. We're seeing patients with much higher free evaluations, particularly T3 which ties again back into the Diogenes posts regarding thyroglobulin acting as an SR agent. Food for thought and if this is the case, the community may want to confront the problems with manufacturers.

helvella profile image
helvellaAdministratorThyroid UK in reply to BirkiNAsa

Weren't those companies behind the very much unlamented Westminster desiccated thyroid product which lasted almost no time on the USA market?

BirkiNAsa profile image
BirkiNAsa in reply to helvella

The company behind that recall was Sichuan Friendly. I've long suspected that this is the same company operating under a different name. But, Medisca still appears on the FDA website with import registration date for their porcine powder.

For recalls and info on NTE, FiercePharma is a great source. Easy to find. Search their site using criteria "thyroid" or "thyroid recall". Also. RLC was recently reported as being sued by the State of Arizona for their product inconsistencies. I know everybody would like to have their old product back, but it was of poor quality and inconsistent. I originated petitions to both RLC and Acella due to their ignoring of many patient complaints.

helvella profile image
helvellaAdministratorThyroid UK

They say this about the very long-established Armour;

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.

waveylines profile image
waveylines in reply to helvella

Sorry not following....... is 'They' the manufacturers of Armour & does a label have to be or need to be approved by the FDA?

helvella profile image
helvellaAdministratorThyroid UK in reply to waveylines

The DailyMed site (which is operated by the USA's FDA) says that about ALL desiccated thyroid products.

That is, Armour Thyroid is just as much not approved as the others including this new one.

(The same was true about all USA levothyroxine products until the first few years of this century. But their repeated inability to reliably produce an acceptable product saw the FDA insisting that they all apply as if new medicines.)

Indeed, I suspect this is one reason for the FDA chasing after making Armour Thyroid a biological product.

Only once they have established much tighter regulation would they be willing to approve it and, possibly, other desiccated thyroid products?

The problem for patients will very largely be cost and possible further restriction on products. But it might result in a better scientific and pharmaceutical manufacturing base for them.

waveylines profile image
waveylines in reply to helvella

Yes but you said label? So Armours been approved by the FDA but not the label. What does that mean? Or have I misunderstood. 🤣

helvella profile image
helvellaAdministratorThyroid UK in reply to waveylines

I just quoted the FDA's standard wording!

I think they might actually be including the full DailyMed entry as the label. Which wouldn't be unreasonable as I can accept the PIL as being an enhancement to the literal label. Further, the USA loves to stick folded up PILs to the tops of pill pots. :-)

No - the FDA has NOT approved Armour as a medicine. But they have not acted to stop it being supplied! A certain intentional ambiguity, I suspect.

waveylines profile image
waveylines in reply to helvella

Thanks Helvella......seems to me theres a fair bit of politics involved too! I guess it's all to do with the Grandfather stuff........wasn't regarded as a pharmaceutical medicine for years....& bobbed along nicely....

helvella profile image
helvellaAdministratorThyroid UK in reply to waveylines

There were recalls - certainly I remember reading of an Armour recall.

But I think it was the appalling issues of levothyroxine - the process of overage, the sub-potency, the inconsistency, the too-great latitude in potency, etc., that really made the FDA turn against so-called grandfathering.

waveylines profile image
waveylines in reply to helvella

And therin lies the truth! Far less recalls or problems with ndt than the synthectics so I suspect the powers that be became heavily influenced by the gigantic pharma & so it all started. What I don't really understand is why the Endocrine Proffession became so anti ndt. And after all these years of hammering ndts as bad bad bad, there IS a group of patients that does better on ndt than any synthectic.....yet the proffession shoots anyone who dares to support its usage. Anyway am going far off piste from this thread but politics/,medicine have become so intertwined....not for the good.

helvella profile image
helvellaAdministratorThyroid UK in reply to waveylines

In the UK, at least, the demise of Thyroid BP was assured when the endocrinologists publicly decried it.

helvella.blogspot.com/p/hel...

However, there had long been an issue that meant the potency of Thyroid BP was not the same as Thyroid USP. And the techniques for assessing potency were poor. (Based on protein-bound iodine rather than actual assay of T4 and T3.)

I wonder if some issues occurred when doctors prescribed Thyroid BP products on the same basis as Thyroid USP products?

And I suspect that the manufacturing was of much lower standards and consistency than we would demand nowadays?

(Inconsistency between makes was a major issue before the Thyroid BP standard was adopted. Even afterwards, at least for some years, both BP and non-BP products were both supplied at the same time by some of the same companies.)

waveylines profile image
waveylines in reply to helvella

Indeed......I accept that maybe ndt products may have had a greater variability, Well they believed that, despite synthectics struggling too to meet the requirements but how erroneous of them to think that synthetics and ndts are the same so ndt could be dispensed with. They are not. It has been a witch hunt that has gathered pace out of all proportion to any true science. NDT should really be seen as an option in an arsenal. It's not opposing the synthectics but compliments them, well established with it long long history of usage. Like it or or not there is a stubborn group of patients who simply do not respond to synthectis even in combination as well as on a ndt. Its a mute point with big pharma. But the profession dug themselves a hole that just gets deeper.....I do wonder when they will reach the other side of the world! Pride & stubbornness reigns at cost to patients. Maybe big pharma makes more money from synthectics than ndt I dont know. There seems to be no end to the madness. An obsession with blood test ranges over presentation of patients, signs & symptoms has compounded the problem. Gross ignorance in the profession of the classic features of hypothyroidism has enabled the disconnect of fantasy from reality to widen even further, leaving people to suffer and not get treatment or be left sub optimal. I do wonder if they will ever wake up!! Shades of grey not black and white thinking is the mentality that needs to shift.....but how much is proffessional politics & profits in medicine that sustains this madness I do wonder. Sorry Helvella will stop my outburst ot outrage. We are both on the same page!! 🤣😂😅

Valeriu profile image
Valeriu in reply to waveylines

I've a friend who I think gets Armour prescribed by the GP....I'm within range so don't qualify but was told if I see and Endo ( private consult) he will then be able to prescribe thyroid hormones himslef once the Endo approves it ....

waveylines profile image
waveylines in reply to Valeriu

What do you mean in range? My prescription wasn't based on my being in range.....if you mean TSH. Have you been fobbed off?

Valeriu profile image
Valeriu in reply to waveylines

I tested privately all my thyroid markers - always only just within range However symptomwise I'm Hypo ....but the GP can't prescribe anything although he agrees I'm Hypo ; He can refer me to an Endo and then the Endo can prescribe if he thinks I need it ....then my Dr can prescribe too; I've just had a private consult for my other hormones as I want to change from the US version to the UK BIHRT version for hormones . However at present I get Erfa via a private Dr and Customised 4U Pharmacy:)

waveylines profile image
waveylines in reply to Valeriu

Sorry thought you meant you couldn't move from an already prescribed thyroid treatment. It's a nonsense isn't it that you have to go private to get treatment that your own doctor can see you need....all because the figures don't add up! I did the private route for a few years until I finally managed to get it on the NHS. Not cheap buying your own and oh so wrong one should be forced down that route.

Valeriu profile image
Valeriu in reply to waveylines

Completly agree and especially if like me you've also got ME ( possibly Lyme) . I just spent a fortune on a consultation with a Menopause Dr but was told once I have the prescription and pay for the creams etc first then my Dr will prescribe....this entire process is around £800 +.....I even told the specialist : you'd think if one already has an autoimmune condition for which there's no cure at present that you'd at least help the patient via the NHS....as it is I'm having it paid by husband as I stopped working 10 yrs ago.....I can pay another fortune once my Dr writes to the Endo but not sure I want to as only am using 30 mg Erfa in the morning ( given up on the 15mg in the afternoon as it's difficult to cut a small 30mg tablet in half) ....:)

waveylines profile image
waveylines in reply to Valeriu

Have you tried a pill cutter? I have to cut mine in half. I can't do it completely accurately, but I simply take the other half the next time. I do understand re GP.....its a battle to get it agreed on the NHS. Even harder when it's ndt. I didn't try for 3years until I was sorted & felt well enough.

helvella profile image
helvellaAdministratorThyroid UK

Please do NOT post where it can be obtained, but can you give us some idea of the cost?

RedApple profile image
RedAppleAdministrator in reply to helvella

It might be a great NDT if you're an American with a healthcare provider who will prescribe it for you. But I don't think it is available for purchase without prescription to anyone outside the US, or through any source other than that specific Pharma company. And it most definitely couldn't be prescribed through our NHS, even by a fully patient centred endo who might be willing to prescribe an NDT such as Armour or Erfa! adthyza.com/for-patients/ex...

waveylines profile image
waveylines in reply to RedApple

The only NDTs listed on the NHS prescription list are Erfa & Armour. All other ndts have been removed. So a NHS Endo can only prescribe one of the two. NP Thyroid was on there but removed after it was found to be grossly wide of the accepted variance levels allowed. No longer made now either. Loved NP Thyroid but yes I had some odd blood test results on what the manufactures stated were the same strength tablets. Hmmm not good. All settled when switching to Armour.

Alanna012 profile image
Alanna012 in reply to waveylines

Have they stopped making NP now?? I bought some in January...

waveylines profile image
waveylines in reply to Alanna012

Oh thats good to hear....didn't realise that. They've definitely winter prescribe NP on the NHS....I had to switch...lol. Have they sorted their variation out in strength. I did love NP...

Alanna012 profile image
Alanna012 in reply to waveylines

Oh whew! Lol no they haven't sorted out the variance issues completely. I had a dodgy batch which made me hypo, between end November and mid January, but in fairness I had a weird one off experience with Armour over a year agothat was the same, and I know that product is more or less consistent.

I am not sure what causes these blips in batches. The way pigs are fed? The source of the excipients on one occasion? I really don't know. I think it does probably happen more often with NP though to be honest.

waveylines profile image
waveylines in reply to Alanna012

You made me laugh till I cried with "The way the pigs are fed" as an explanation to variation in batches..... I cant stop laughing. I have images of little piggies being fed in all sorts of wondrous & wonderful ways.....please dont give the manufacturers ideas!! Can't get these images out of my head!! 🤣😅😂😂🤣😅

Alanna012 profile image
Alanna012 in reply to waveylines

🤣🤣🤣 well one wonders....

waveylines profile image
waveylines in reply to Alanna012

Thing is there are recalls with synthectics.....more so.....but they tend to slide away quietly but if poor old ndt has a blip they get shot....must be like walking a tight rope!! I was sad to move off NP but retirement loomed & I was concerned of the cost of self funding, prices have shot up so I switched. Didn't feel well on Armour for a good 3 months and then suddenly my body adjusted and I felt fine. It was a bit of a lesson to me that even though the active ingredients were the same it took quite a while for my body to adjust to it. Intriguing really.....

Alanna012 profile image
Alanna012 in reply to waveylines

Ah that's really interesting, thanks. I guess I've never expected it to take so long to adjust. I think I'll wait longer before giving up on an NDT trial next time.

waveylines profile image
waveylines in reply to Alanna012

I think I persevered cos I didn't want to go back to self funding. Its not to say that that would happen with everyone.....I've been on ndt for a very long time so I already know its for me, just a question of which one. I've got to say I didn't need a 3 month settle in period with NP Thyroid. Bare in mind my dose was stable I was just switching brands. Very different ball game.

BirkiNAsa profile image
BirkiNAsa in reply to Alanna012

No. Still available.

in reply to helvella

I’m afraid I don’t know anything other than the name of it and the fact it is a new NDT. I have been trying to find out more but bureaucratic research has never been my strong suit…

Poniesrfun profile image
Poniesrfun

adthyza.com/for-patients/ex... The pharma company is in Massachusetts.

No NDT its FDA approved. Synthroid was only approved in 2003 or 2007 because it had so many potency issues - NDT brands actually had much better track records.

waveylines profile image
waveylines

It is a ndt made from natural porcine extract.....listed on the prescription information. So not a synthectic combined tablet. Interesting. Clearly the market it out there for it & I'm please to see it. Not sure about the fillers......but then some other very popular ndts (until they went our of production) contained scary fillers like aluminium. I have to say am happy on Armour so shan't be switching. 😊

Valeriu profile image
Valeriu

I would be interested to find out as my Erfa NDT is quite expensive and obtained with a private prescription; I have used Thyrovanz NZ in the past - it was also very good and not expensive Thanks for this post :)

Bhattinsami profile image
Bhattinsami

hi instead of using the NDT i would like to suggest to use a homeopathic medicine named THYROIDINUM which is made from thyroid gland of sheep and which is very effective as well in personal experience treating both hypothyroidism or hyperthyroidism.

Alanna012 profile image
Alanna012 in reply to Bhattinsami

Interesting, thank you, plurality of choice and options is always a good thing.

tattybogle profile image
tattybogle in reply to Bhattinsami

Hi Bhattinsami ... It is important to state that Homeopathic Thyroidinum dose not contain any thyroid hormone .

It cannot be used as a substitute for NDT which contains both thyroid hormones (T4 and T3) It cannot replace low T4/ T3 levels in hypothyroidism .

You situation was quite unusual , you have thyroid antibodies for Graves and Hashimoto's , and so far you have not had much need of replacement T4 and T3 . But if you ever do become severely hypothyroid with low T4/T3 levels , then Thyroidinum will not be able to provide them .

You were first treated with a very low dose of Levo 25mcg for a few yrs .. then went mildly hyper (fT3 marginally over range)..and came off Levo . Then you were put on a very low dose of carbimazole for 5 months last year , tapered down to none, and are now discharged.

Your TRab are capable of balancing things out for you , by stimulating your thyroid to overproduce T4/T3 sometimes . Therefore your Hypo / Hyper conditions can sometimes balance each other out ~ which is probably what is happening at the moment ~ hence you currently not needing either Levo or carbimazole .

Thyroidinum may well have helped you , (and i'm not knocking homeopathy at all .. i'm all for it in fact, and have found very it useful myself on occasion) , but it has it's place ..it cannot be used as a method of replacing missing thyroid hormones in the treatment of hypothyroidism.

Your unique balance of thyroid antibodies is the reason why you don't need to take any replacement thyroid hormones at the moment . Most cases off Hypothyroidism do not have any TRab , they need to get some extra T4/T3 from somewhere .. they can't get them from thyroidinum.

Suggesting they try it 'instead' of NDT would cause then to return to a hypothyroid state .

Bhattinsami profile image
Bhattinsami in reply to tattybogle

hi there . thanks for the message .. i’m just quoting the example of my family . the similar things happened to my husband as well .. in january last year his LEVELS shot up too high . then we started taking thyroidinum and few other homeopathic medicines for rapid heart beat and results started improving . along with that he took 40mg of carbimazole which the GP has now taper in down to 10mg .. i’m attaching the results with my message .. i’m not advising anyone , just sharing my experience

Received: 13 Apr 2022

Provider Sample ID: JC703205D

Pathology Investigations

Thyroid function test Hyperthyroid profile.

Advise referral to Endocrinology.

Results phoned to Jamela, GP receptionist

13.4.22 1725.

Serum free T4 level > 100.0 pmol/L [11.0 - 26.0];

Outside reference range

Serum TSH level < 0.02 mU/L [0.27 - 4.2];

Outside reference range

Serum free triiodothyronine level 36.8 pmol/L

[3.1 - 6.8]; Outside reference range

and the results in november show

results
tattybogle profile image
tattybogle in reply to Bhattinsami

presumably the T4 /T3 are lower in Nov due to him taking carbimazole to control the very high levels of T4/T3 production, rather than the homeopathic remedy ?

Homeopathy was not used as a 'substitute' for antithyroid drugs in your husbands case, , (nor in yours when you wer hypo, then hyper).. you have used it 'together with' them .. which is fine to suggest to people , would do no harm and may well have benefit.

I commented because you wrote "instead of ... using the NDT...." which would cause serious problems in anyone who followed that suggestion .. (as it would, if it was used 'instead of' an antithyroid drug) .

BirkiNAsa profile image
BirkiNAsa

I'm from the U.S. and would like to join this conversation if nobody minds. From about mid-last year, newer Armour has given me anxiety and panic which I have never experienced prior. I have had to cut my dose from 1.75 gr to 1.25. I have gone back to an older compounded version of NDT at my old dose that did not cause this problem. There have been a couple of reports that "NDT" is now "NTE". And that the removal of thyroglobulin and a new extraction process deriving only T4 and T3 are giving patients a far different result than what they are used to.

And, quite by accident, I had a thyroglobulin measurement taken that showed me "low" on newer Armour, which should not have been. (NDT contains enough thyroglobulin that it can confuse thyroid cancer patient amounts).

The Diogenes info posted seems to correlate with my experience. I'd love to get some of your thoughts. If I/we of us experiencing this are correct, then our old NDT, irrespective of brand, is missing thyroglobulin, T1 and T2.

Lilac200 profile image
Lilac200 in reply to BirkiNAsa

Hi, I'm in the US, and I found your comments about Armour really interesting. I always have trouble with a lot of these thyroid drugs since Synthroid changed formula many years ago, but Armour seemed to be giving me a hard time with nervousness soon after I took some, this past weekend And I've just had labs done; the results were OK enough that I shouldn't have experienced this.

I actually found this discussion because I was looking for reviews on Adthyza, the "new" one that's come out. I put "new" in quotes because it's another natural drug but made by a new company, with a bit different fillers, etc. My endocrinologist actually gave me a prescription for a small amount of Adthyza, if I wanted to switch it out for the small amount of Armour I've been taking, daily (in addition to some other thyroid med). I tried a half of this small Adthyza pill today......I think it may be hitting me too hard; I may try it again in a few days and go back to the Armour it was meant to replace, for now. Dr. doesn't care; he says whatever I can work with better is OK with him. It's really frustrating, though, as neither Armour nor Adthyza may be great choices for me...though others may do well with either of them..

Again, I appreciate reading your remarks on Armour. Thanks for posting about it!

humanbean profile image
humanbean

I thought this thread would be a good place to link to this article on Adthyza, which was published on 23rd March 2023. It appears on Westin Childs' website :

restartmed.com/adthyza-thyr...

The comments are worth reading as well as the article.

Lilac200 profile image
Lilac200 in reply to humanbean

Yes, I thought the article and comments were really good, for anyone interested in Adthyza. Good of you to post it!

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