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Month: July 2009

Why Forest Labs had gotten away with a “newly formulated” Armour that is causing so many problems

Armour tablets

 

This post was originally written in 2009, and gives you great history as to the disappointing change that happened to Armour as reported by patients. But it happened again in 2015, and you can read that here: //www.stopthethyroidmadness.com/2015/09/19/armour-and-unhappy-thyroid-patients/

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Numerous and ongoing comments to my blog posts below about the newly formulated Armour are shocking and despairing.

Additionally, thyroid patients are crying out about the loss of being able to do Armour sublingually. (Was Forest Labs not paying one hoot of attention to thyroid patients the last few years in their praise of Armour because of it’s sublingual effectiveness??) Sublingual administration was a godsend for thyroid patients who had digestive issues, including gluten intolerance and Celiac, as well as those who needed to take iron tablets (which you can’t do at the same time as you swallow desiccated thyroid, but could do with taking Armour subingually)

So how in the world did Forest Labs get away with reformulating and producing a product that so many patients are reporting to be problematic?

It’s not FDA approved. As many of you may know, Armour desiccated thyroid, even when it was produced by a pharmaceutical other than Forest Labs, was around far before the FDA (Federal Drug Administration) came into being in 1938.  That’s why it does not have the designation of  “FDA approved” as do those drugs which were created after the FDA existed. It’s called an unapproved drug, but Armour was presumed to be safe and effective already.

From the FDA: Under the 1938 grandfather clause (see 21 U.S.C. 321(p)(1)), a drug product that was on the market prior to passage of the 1938 Act and which contained in its labeling the same representations concerning the conditions of use as it did prior to passage of that Act was not considered a new drug and therefore was exempt from the requirement of having an approved new drug application.

Because it’s not “FDA-approved”, it does not have an NDA, aka New Drug Application. An NDA is used by the FDA to establish if the pharmaceutical product is safe,  EFFECTIVE, more beneficial than side effects, and has in-house  “controls” which maintain the quality, strength and purity of the product. (Thanks to “Ben” the pharmacist for reminding me of this.)

So…without that NDA, Forest Labs is, and has been, on their own, including with the latest introduction of a newly formulated Armour. So you might say, WE as patients were the guinea pigs.  And sadly, we’ve been squealing and it’s a muddy picture.

The most important fact to state: USP (United States Pharmacopeia) desiccated thyroid is an effective and important drug which is changing the lives of a huge and growing body of individuals around the world. That was evident before Armour was reformulated, and is still evident with products like Naturethroid or Westhroid, which many patients are switching to.  See my blog post about Naturethroid here, plus RLC Labs comment about Naturethroid here.

But something has gone terribly wrong with the reformulation of Armour, and patients appear to be leaving it behind in the dust in favor of another great and effective brand like Naturethroid. And whether it’s the fillers are not, Forest needs to take a new look at their reformulation of what was once a GOOD product, and hopefully this time, LISTEN TO PATIENTS.

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69 replies

Doctor questions if adrenal fatigue is real….so is it??

Screen Shot 2015-08-13 at 1.26.06 PM(This page was updated. Enjoy!)

In 2009, Louis Neipris, M.D., a staff writer who has written many fine articles for myOptumHealth.com, wrote one article titled Adrenal Fatigue: Is it for real?

It appeared on Upper Michigan News, TV 6 website on July 16th and made the rounds on other sites.

His answer to his own question?  “Not really”. He adds  “It’s not an accepted medical diagnosis.”

Oops. Thyroid patients and a growing body of informed medical practitioners beg to differ.

About the term “Adrenal Fatigue”

Patients in the earliest discussion groups were using the term “adrenal fatigue” right after the turn of the 21st century, probably because they saw it used so often on the internet, as well as referred to in certain books. And we did think that the adrenals became “tired” as a way to explain the low cortisol we outright saw in each other’s saliva results, as well as symptoms. The term “adrenal insufficiency” also fit.

Later, it became more popular with patients to identify the biological cause of our low cortisol as being rooted in a sluggish HPA axis, i.e. the messaging between the Hypothalamus to the Pituitary to the Adrenals. That messaging wasn’t as vibrant as it should be.

Fast forward to the 2014 book Stop the Thyroid Madness II, where the last chapter by Dr. Lena D. Edwards et al does a bang-up job explaining what might really be going on, and which they term “hypocortisolism”. They propose five brilliant and biologically valid reasons why we see low cortisol:

  • a developmental response to high stress
  • a corticotrophin-releasing factor (CRF) receptor down-regulation
  • inadequate glucocorticoid signaling
  • intrinsic adrenal gland dysfunction
  • an adaptive response towards infection or inflammation.

See Chapter 13, pages 291-292 for more details on each of the five. It’s a brilliant chapter on the subject within the STTM II book.

In other words, there are explainable and logical reasons why certain thyroid patients have low cortisol, and it’s very real, whether you call it adrenal fatigue, adrenal insufficiency or hypocortisolism.

The cortisol saliva test

One excellent method, we as informed patients, prove our low cortisol state is by the use of saliva testing. The important aspect of saliva testing has been two-fold: 1) it reveals our cellular level of cortisol, which we’ve noticed has always fit our symptoms (if the facility we use knows that they are doing, as do the ones listed on the Recommended Labwork page which do not need a doctor’s prescription), and 2) it tests us at four key times during a 24 hour period (which is important to see the fuller picture of what our adrenals are doing.)

We’re learned repeatedly, in comparison, that blood cortisol is not the way to go, since with blood, you are measuring both bound and unbound cortisol. And as informed patients, we have noticed that blood cortisol can look high, yet both saliva testing and our symptoms reveal we are actually low, cellularly. We’ve even seen blood cortisol measure low, yet saliva and our symptoms reveal high…even though it’s less common that the other way around. It’s uncanny! Also, with blood cortisol testing, a misinformed doctor will only do one test instead of the needed four.

What has been the impetus behind the low cortisol state of a large body of thyroid patients?

Two very clear reasons:  first, being held hostage to the TSH lab test, giving one a “normal” reading for years in spite of obvious clinical presentation of hypothyroid symptoms, and pushing one’s adrenals into overdrive with high cortisol and adrenaline to keep the patient going, and ultimately leading to the downwards spiral of adrenal fatigue/adrenal insufficiency/hypocortisolism.  On page 65 of the revised Stop the Thyroid Madness book, you’ll read about a 44 year old woman who went 15 years with a “normal” TSH result, in spite of obvious clinical presentation of hypothyroidism, and which led to her own low cortisol. This is not uncommon.

Second, the risk of adrenal fatigue is high due to the inadequate treatment of T4 medications like Synthroid, Levoxyl, levothyroxine, Eltroxin, Tirosent and other T4-only meds. Because of being forced to live for conversion alone, and missing out on the compliment of all five thyroid hormones, T4-only meds leave a high percentage of patients with their own brand and intensity of lingering symptoms of a poor treatment…sooner or later…forcing the adrenals to kick in for too long, for many.

Even William Mck. Jeffries MD., who wrote the medical classic Safe Uses of Cortisol around 1984, understood the preponderance of adrenal fatigue and low cortisol, even without the diagnosis of Addison’s disease, and the need for physiologic doses of cortisol treatment, or the amount needed by each individual’s body to function correctly.  And he would certainly be amazed by the explosion of adrenal fatigue that has occurred since then in thyroid patients thanks to the lousy TSH and synthetic T4-only ‘affaire de coeur’ with doctors.

Adrenal fatigue may not be an “accepted diagnosis” by some medical professionals.  But today, there are a growing body of open-minded practitioners who recognize its reality as an acceptable diagnosis, and for which we are grateful.  Now our job as patients is to make sure our more open-minded doctors understand what we have on how to treat it! 

JanieSignature SEIZE THE WISDOM

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** Chapters 5 and 6 in the revised STTM book contain the best details about adrenals and treatment in any book. 

** Here’s a page on STTM listing a variety of symptoms related to a cortisol problem: //www.stopthethyroidmadness.com/adrenal-info/symptoms-low-cortisol/

45 replies

Thyroid tidbit: interesting comment from makers of Naturethroid

The following comment by RLC Labs, a pharmaceutical which has made desiccated thyroid like Naturethroid since the 1930’s, was sent in a letter to a pharmacy. You may find it interesting as compared to problems so many have reported with Forest Labs and the newly formulated Armour:

We have never had any mandatory or voluntary recall of any of our thyroid medications due to inconsistency in dosages. Our formulation and preparation is able to stabilize the T3 and T4 hormones through its entire expiry period (3 years from manufacturing) providing additional assurance to both physician and patient alike in quality and consistency of our strengths.

Kudos for RLC Labs and Naturethroid! Patients whose lives have changed ten-fold thanks to desiccated thyroid need a good product. (And we’re going to hope down the line that “someone” will create desiccated thyroid in a sublingual form.)

P.S. If you don’t know what has happened to Armour and patient experiences with it, scroll down.

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*SALE! Stop the Thyroid Madness T-shirts are now 50% off just because I like sales. A great way to spread the word about our patient revolution for the superiority of desiccated thyroid over T4-only meds. You’ll also see funny bumper stickers. Also…when you order the STTM book and request it,  you get a Calvin peeing on….(you’ll see) bumper sticker for FREE, and it’s a hoot.

38 replies

I am done with Armour, say a growing body of individuals

donewitharmourThis page was originally written in 2009, and can be read for historical value as to what happened. But once again, Armour appears to have once again changed in 2015, which you can read about here. 

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Once again, I just approved one more comment of someone who has had it with Armour, and is switching.   On the new Armour, she states she has a return of her former hypo symptoms: hair loss, joint pain, fatigue, heart palpitations, low body temps are back, etc.

And you see it happening all over thyroid patient groups on the net.  Many folks are done with Armour.

It’s too chalky. It tastes terrible.  It doesn’t break into smaller pieces well anymore.  It’s lost the ability to be done sublingually. And even worse, it has caused a return of symptoms.

In case you are wondering what this is all about, read the 40 current comments attached to the June 2nd post Trying the Newly Formulated Armour? Before that, you can read my May 7th post Why the party is over with Forest Pharmaceuticals and the current 37 comments.  And especially powerful is the April 28th post Patients say PHOOEY to new Armour formulation and Forest Pharmaceuticals with a current 57 posts.

So what’s their next step?

Right now, doctors of patients on Armour on being asked for a prescription for Naturethroid. Many report it working wonderfully; some state they need a little more to be as optimal as Armour. A small minority aren’t sure about it yet. But overall, the majority are happy.

So let’s get an update of those who have switched: what product did you move to? Is the same amount giving you the same results? Did you have to more to a slightlyl higher amount, or lower amount? Was your pharmacy cooperative for a different brand?  Did you have to explain to your pharmacy that Naturethroid can be drop-shipped directly to them?

P.S. Thyroid patient Cheryl emailed me and said she is sending the above posts about Armour’s problems to practically everyone on her email list, hoping they in turn will send it to their friends, and the word will get out.  If you want to do the same, this post is the most updated, and includes the links to the former posts.

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119 replies