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Tag: sublingual

How are YOU doing with the current desiccated thyroid shortages?

Pills Spilled Shortages

(This post garnered a lot of attention, up to FIFTY comments just a few hours after it went up. People are very interested in sharing their experiences in coping with the shortages! See below and add your own.)

This year will go down in history as shockingly miserable for enlightened thyroid patients on natural desiccated thyroid.

First came a reformulation in the most popular brand–Armour by Forest Labs. Patients worldwide in groups and forums reported a serious return of their hypothyroid symptoms on this product. A huge disappointment.

Second came the production shutdown of the two generic makers of desiccated thyroid: Time Caps Labs and Major Pharmaceuticals. It’s the first step in the FDA’s compliance plan to corral all grandfathered-in drugs (drugs already in existence when the the FDA was created in 1938) and make them each prove the efficacy and safety of their medication via very expensive clinical trials.  i.e. over 110 years of safe and effective use of desiccated thyroid is not enough for the FDA?? We are still waiting to see the outcome of that plan with RLC  and Forest Labs.–the two who were actually in existence before 1938.

Third came demand being greater than supply and shortages. Because of informative patient websites like Stop the Thyroid Madness,  Sheila’s TPA-UK, Lyn’s ThyroidUK, Stephanie’s Natural Thyroid Choices, some areas of about.com (and other good websites I don’t mean to miss here), plus many fine patient forums and groups,  patients found out why they had continuing symptoms on T4 thyroxine, and demand for natural desiccated thyroid grew exponentially.

STTM then created a list of options for all thyroid patients until the shortages resolved themselves, and also created CDT (Coalition for Desiccated Thyroid) where patients could discuss alternatives in a supportive and factual atmosphere.

And we’ve seen some interesting experiences and comments:

The new Armour: One grain tabs started to appear on some pharmacy shelves the past month.  Other pharmacies have still been waiting.  Many patients appear to have switched to other alternatives, though. One gal still on it feels she is finding success by adding T3 to the amount of new Armour she is on.  Time will tell if patients can ever find success with the newly formulated Armour, and most feel it’s a huge loss.

Naturethroid and Westhroid: Patients reporting on their switch to either of RLC Lab’s two identical products report doing well, having to raise it slightly or lower it slightly, or just not liking them at all. Others have had a hard time finding it on their pharmacy shelves, but have been seeing some appear in the last few weeks.

Erfa’s Thyroid from Canada: When it became clear that the FDA was allowing this excellent product to be shipped to patients, many switched and had their prescriptions faxed to a Canadian pharmacy. Prices at many of those pharmacy websites were doubled after prescriptions started to come in from the US. Most patient who stuck with it seem to love it, reporting you can do it sublingually, as well. A few haven’t been impressed, but were finding their former success by raising it.

Compounded desiccated thyroid: In spite of being a more expensive option, some patients found success with this. Others learned they preferred the filler to be Acidophiles.  If not the latter, Microcrystalline Cellulose was preferred over Methyl Cellulose–the latter which appeared to lessen the effectiveness of the compounded thyroid.

Synthetic T4 and Synthetic T3: some patients switched back to the synthetic combination, but many report that it hasn’t been as effective as desiccated thyroid was.

Other options: Patients moved to OTC products like Nutri-Meds, etc, which can be much weaker. Others sought desiccated thyroid from other countries and have found success.

So I’d like to hear from all of you.   Did you go back to synthetic T4?  What desiccated thyroid did you switch to? What worked and why? What didn’t work for you and why?  What product do you hope to switch to once you run out of your current meds?

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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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Tips on how to do desiccated thyroid sublingually

Though this was originally posted in 2009, it’s been updated to the present day and time!

The brand of Natural Desiccated Thyroid called Armour used to be easy to do sublingually, even if the official line was they didn’t make it that way. That means letting it dissolve under the tongue which can potentially make its way to the sublingual gland under the bottom of the mouth and more directly to the cells.

And patients liked that sublingual ability with Armour.  It allowed them to work around the problem of swallowing desiccated thyroid several hours from having swallowed iron, estrogen or calcium–all which can bind ‘some’ of the thyroid hormones in your stomach.

It also helped those with digestive issues, since some of it may be bypassing the stomach.

But with the first newly formulated Armour in 2009, it became difficult. The pill became harder with less dextrose and more cellulose.  It now fell into the ranks of all other desiccated thyroid pills, including Naturethroid and other good brands, as a more dense tablet.

Tips from patients on how to do sublingual

Even for those NDT brands which are made quite hard, below are tips from patients on how to continue doing  desiccated thyroid sublingually. Let your doc know, too.

1) Some are adding a tiny touch of the contents of a Pixie Stix under their tongue. It’s flavored sugar in a straw, and the sugar seems to help the tablet dissolve sublingually through tissues under the tongue.

2) If you are using sublingual B12 lozenges to treat low B12, try adding it under the tongue with your desiccated thyroid. The action of the sublingual lozenge seems to move over to the thyroid tablet, say some.

3) Swish warm water in your mouth before you place the tablet under your tongue.

4) Crunch up the desiccated thyroid tablet before any of the above and before placing it all under your tongue.

Can’t I just swallow my NDT?

Definitely. You’ll just have to make sure you don’t also have a stomach full of iron rich foods, calcium or estrogen. Generally, it’s best to take your tablet away from any of the former, such as a two hour difference at the minimum.

*Have more sublingual ideas or experiences? Share it in the Comments section.

*Want to be informed of my blog posts? Curious what’s on my mind? Just use the Notifications to the bottom right of the links.

56 replies

Why the party is over with Forest Pharmaceuticals, the makers of Armour

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Janie wrote the following in 2009 about Armour, and wouldn’t you know, 2015 sees another problem with Armour!

In 2002, when I first got on natural desiccated thyroid and it absolutely changed my life, it happened to be the brand name called Armour by Forest Pharmaceuticals.

And I swooned.

You could do it sublingually (even if it wasn’t made that way), and I praised Armour for that. So did other patients after we spread the word on patient groups, on the STTM website and in the Stop the Thyroid Madness book.

My fondness for Armour did not take away my praises for other prescription brands, though, including Naturethroid or Westhroid by RLC Labs.  I simply made a doe-eyed commitment to Armour for my personal treatment because you could do it sublingually. I have also used the name “Armour” interchangeably to represent all good desiccated thyroid products.

But because of a succession of three events, I think it’s time to give back my going-steady ring.

The first blow to my romance with Armour centered around the extreme tight-lipped secrecy from Forest when the reformulation of Armour began.

We can surmise the trouble begin in 2007 when patients were finding Armour in the larger sizes to be suddenly ineffective.  For the entire year of 2008, supplies were extremely limited and only the one grain size or lower could be found, if at all.  Patients were worried and unhappy.  I even supported Forest in my blog posts, assuring patients that everything would be fine.  But Forest said practically nothing. Why was and is Forest mum about why this was happening ?

The second blow to our courtship was the change to the “reformulated” Armour

Suddenly, patients find that doing Armour sublingually was a thing of the past. Now all we get is a never-ending chalky pasty residue under our tongues.  Additionally, many patients have been reporting that the amount of Armour that once removed all symptoms, was now bringing them back.  Huh?? In spite of an apparent drawback in some batches in 2007, why would Forest take an effective product and change it?

And the third and final straw to my affair of the heart?

I made a phone call to Forest using the same 800 number you all can use. That was Tuesday, May 5th. My intent was to ask about the word anhydrous which is now after the ingredient dextrose in the Armour ingredients listing. (It means that all moisture has been withdrawn, but I wanted to confirm the details for the brands page.) 

When I reached the representative for Forest, and after she asked my name and I gave it (oops),  the tune of the conversation changed.  She said she could not answer my question since I own a public website, and would have to inform the “Media group” from Forest, and they would call me back. When I asked when, the answer was a vague as Synthroid is in treating hypothyroidism i.e. she didn’t know. I even called back the next day to get the same dribble.   Why have representatives on the Forest hotline been instructed not to answer a simple question from someone like myself,  and I still have not received a phone call from Forest?

Sob.

Yup, breaking up is hard to do, but a gal can only take so much strange betrayal, tight-lipped silence…and ignoring a simple question from someone who has done a LOT to put money in their pockets out of extreme gratitude. Thank goodness there are other fish in the sea.

JanieSignature SEIZE THE WISDOM
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Thyroid patients say PHOOEY to new Armour formulation and Forest Pharmaceuticals

armourtabletsugh1 As the “newly” formulated Armour desiccated thyroid pills, made by Forest Pharmaceuticals/Laboratories, have been hitting the market, so are comments coming out from some thyroid patients…and they are not in the least complimentary.

The reason that Armour had been favored by so many thyroid patients among all the desiccated thyroid brands is the ability to take it sublingually.  Sure, Armour was never officially made to be taken sublingually, but it worked.

Sublingual refers to the administration of a medication via the millions of tiny capillaries that line your mouth and mucous membrane. The pill was placed under the tongue and allowed to dissolve–most of it entering the body directly via your sublingual glands, and only a small amount swallowed.

Some patients who switched from swallowing to sublingual noticed the difference, too.

But the beauty of sublingual has gone even farther than noticing anything different. First, it was always a known “baddy” to swallow any pills that might contain iron, estrogen or calcium at the same time we swallowed Armour or any other desiccated thyroid brand. Why? All three interfere with and bind a certain percentage of the thyroid hormones in our stomachs.  We were forced to take any of those hours apart from swallowing our pill. So doing the Armour sublingually allowed us to swallow the above pills, or drink milk, or eat high iron foods, at our own timing and not hours away.

Second, the old formula was usually gone in our mouths within 30 minutes give or take. Now, patients who take their newly formulated pills sublingually (which now has less dextrose and more cellulose) despise the “chalky, pasty, gritty residue” left in one’s mouth.  It also results in Armour taking far too long to be properly absorbed.

Third, those with adrenal fatigue can find themselves waking up with nausea due to the morning low cortisol. And being able to take Armour sublingually bypassed the need to swallow a liquid to take a pill and promote more nausea.

Fourth, those with Celiac disease, and even those with standard low thyroid digestive issues, found sublingual administration to help their absorption of what desiccated thyroid offers, which they didn’t get well if they swallowed the pill.

All in all, the buzz around patient groups or on comments here  about the newly formulated Armour is not complimentary.  It doesn’t work well sublingually. It’s too chalky. It leaves a gritty paste in your mouth.  And patients are highly disappointed.  Let’s hope that one of the pharmaceuticals takes the ball and runs to create a sublingual desiccated thyroid.

What is your experience with the new formulation? Are you still trying to do it sublingually?  Have you found doing Naturethroid sublingually works? Are you switching to Naturethroid or Westhroid out of principal, as many are stating they are doing? Use the comment section and let’s talk.

*Express your opinion to Forest here: 1-800-678-1605, ext. 66297.

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108 replies