(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?

She spoke with Lena Choe of the FDA. She is a pharmacist in the Division of Drug Information at the FDA.

Choe stated that they are not taking current action with Forest Labs and RLC Labs in regards to Armour and Naturethroid. Instead, they will simply be requiring them to go through the New Drug Application process, and they will require data. Data is possibly referring to the clinical trials that both companies will have to perform to get results on the efficacy and safety of desiccated thyroid.

Choe stated that the FDA is very aware of problems with Armour and will be looking into that eventually. The FDA takes priority actions on medications based on consumer complaints.

A comment which I found hopeful from Choe was her knowledge that desiccated thyroid has already been used in humans since the 1962 amendment. That’s a good track record of 47 years, folks, that the FDA is referring to. Of course, many of us also know that Armour had a good track record since the 1890’s.

1962 represents the year the FDA established the “Drug Efficacy Amendment”, also called the Kefauver Harris Amendment. The amendment requires that pharmaceutical drug manufacturers provide proof of the effectiveness and safety of their drugs before they can receive FDA approval, aka clinical trials and the data that results. The amendment also requires accurate marketing information on side effects (think Bob and erectile dysfunction on those irritating, nauseating commercials).

And again, it still appears as I stated below that both Major and Time Caps were told to cease production due to being “new” companies since 1962 producing desiccated thyroid. That is a different issue than RLC and Forest.

Hang onto hope, folks. Because by the limited information everyone gets when they call the FDA, it points to a good reason to feel positive, not to think the worst…at least for me. Sure, it’s maddening they would shut down whatever production was left of desiccated thyroid. And it’s equally frustrating that we hang by threads as far as FDA communication. But right now, as I also thought a few days ago, I don’t think the FDA is shutting down production of RLC and Forest, or will during the NDA process. We just have to wait for supply to catch up, especially with RLC. So we’ll see what passes.

No, they are not ceasing to make desiccated thyroid. They just weren’t prepared for the high demand due to the reformulation of Armour and problems it caused.  And they aren’t keeping up and won’t for several months.

So, if you can’t last with your current prescription for several months, you will probably need to talk to your doc about getting a generic version by Major Pharmacy, or get some over-the-counter like NutriMeds, or even the “Hypo Support Formula” made by RLC Labs, but expect to take much more of either.  Many patients are also mentioning Thyroid-S by Greater Pharma as a backup until RLC catches up.  But it’s by mail order and will take a few weeks to arrive.  Google any of the above. Finally, you can move a slight step backwards and talk to your doc about doing synthetic T4 and synthetic T3.  It’s not going to be quite a good as being on desiccated thyroid, but it’s certainly better than being on T4 alone, don’t you agree?? Keep connected to your doc.  And hang in there. This will pass.

Janie

P.S. I’ll be adding more information to this post tomorrow. Check back.

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Below is the actual release by RLC Labs:

For any patients experiencing difficulties in attaining either Nature-ThroidTM or WesthroidTM through their pharmacy, RLC Labs, Inc, asks these individuals to have their pharmacy contact us directly at 877-797-7997 to place an order, or have their pharmacy request a drop-shipment through their wholesale supplier.

RLC Labs’ products are only available through wholesalers, pharmacies and or their doctors; thus all confirmations and/or tracking information will only be available through the wholesaler, pharmacy, or doctor’s office that placed the order.

RLC Labs is experiencing a substantial increase in orders for Nature-ThroidTM and WesthroidTM. The recent unexpected influx has inundated our customer service and shipping departments, thus causing delays and depleting our current stock. We are working around the clock to fulfill all current orders; however, we cannot guarantee that
any future orders will be fulfilled until our stock is replenished.

RLC Labs will continue to accept orders from our customers, however as of Friday August 14th, we are backordered on all strengths of Nature-ThroidTM and WesthroidTM. Shipment is expected to resume within 90 days.

We regret to inform you of this situation; however, we can assure you that we are working diligently to replenish our stock and will resume shipping as soon as possible. Please accept our sincerest apology for any inconvenience.

We do understand how much of an impact this has as most of us employed @ RLC Labs, are hypothyroid and take our own product. Thus, we know and understand how important it is to get product back into the market place. We are grateful for your continued patience, patronage and support!

Feel free to contact our customer service department with any questions concerning this matter @ 877-797-7997.

Thank you from all of us @ RLC Labs, Inc.

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.

*Want to be informed of these important blog posts? Curious what’s on Janie’s mind? Just use the Notifications to the left and below the links.

*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 (i.e. you have to request it),  you get a Calvin peeing on….(you’ll see) bumper sticker for FREE, and it’s a hoot.

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.

*Want to be informed of my blog posts? Curious what’s on my mind? Use the Notifications on the lower left of the links.

*Have depression and you are on a T4 med like Synthroid, Levoxyl, levothyroxine, Eltroxin, etc?? Read the blog post below.

Funny how things work. I had been wondering what the heck was going on with thyroid patients in the UK after the Royal College of Physicians (RCP) came out with their February 6th guideline stating that 1) thyroxine was the only medication needed for hypothyroidism, 2) “natural” medications were dangerous and 3) the only labs needed are the TSH and T4.

All the above goes totally against the life-changing experience of a growing body of patients.

Equally a part of this B-grade horror movie is the stand taken by the British Thyroid Association (BTA).  Read it. And UK-TPA thyroid patient advocate Sheila Turner began to go through her own hell when her Armour was taken away, which you can read about in the February 20th blog post here.

And suddenly, I get an email from Sheila, informing me that the RCP stand is as bad as it was three months ago for her and other thyroid patients.

Sheila states: This is absolutely unbelievable that out of the hundreds of references we sent to the Royal College of Physicians to show their guideline to be flawed, they have taken no account of one single one of them. They are publishing their previous guidance without one since change. The world has gone mad.

Dear Sheila, Further to my email of 6 April, the comments and materials received by the College have been reviewed. This position statement or guidance (not a guideline) was produced on behalf of the Royal College of Physicians, in particular its Patient and Carer Network and the Joint Specialty Committee for Endocrinology and Diabetes; the Association for Clinical Biochemistry; the Society for Endocrinology; the British Thyroid Association; the British Thyroid Foundation Patient Support Group and the British Society of Paediatric Endocrinology and Diabetes and is endorsed by The Royal College of General Practitioners. The President has asked me to let you know that this review has not resulted in any changes to that statement.  It should be noted that it is about the treatment of primary hypothyroidism and does not preclude other treatments for exceptional cases by specialist endocrinologists who can make clear to patients any associated risks. References supporting the statement are listed below. Yours sincerely, Catharine Perry Administrator •   Diagnosis and treatment of primary hypothyroidism. BMJ 2009;338:b725 •   Vaidya B, Pearce S. A Clinical Review of the management of hypothyroidism in adults. BMJ 2008;337:a801. This contains references for 35 articles and states that Armour thyroid is of no proved additional benefit to levothyroxine. • The Lancet Volume 363, Issue 9411, Pages 793 – 803, 6 March 2004.  This covers the history, epidemiology, pathophysiology, and clinical diagnosis and management of hypothyroidism and is written by Caroline GP Roberts and Paul Ladenson of Johns Hopkins University School of Medicine, Baltimore, USA.  This review, which references 164 clinical articles, states that the treatment of choice for hypothyroidism is levothyroxine sodium (thyroxine) and does not refer to Armour thyroid. •  Baloch Z, Carayon P, Conte-Devolx B, et al. Laboratory medicine practice guidelines. Laboratory support for the diagnosis and monitoring of thyroid disease.Thyroid 2003;13:3-126. •  Association of Clinical Biochemists BTA, British Thyroid Foundation. UK Guidelines for the use of thyroid function tests. http://acb.org.uk/docs/tftguidelinefinal.pdf •  Surks MI. Ortiz E, Daniels GH, et al. Subclinical thyroid disease: scientific review and guidelines for diagnosis and management. 2004;291:228-238.

And as your peruse the six references above which they use to defend their tunnel-visioned, moronic position, you realize that you, your words, and your positive-outcome experience on desiccated thyroid, as well as the use of far better labs, is about as important within the UK’s latest medical pronouncement as is dirt on the bottom of a rusted bucket in the middle of an empty field in nowhere. Yup.

Or as Harold Shipman stated about the RCP’s guidelines: What a brilliant wheeze.

******************************************

See below on the potential importance of potassium in your health and well-being. And on the May 7th post about the party being over with Forest Pharmaceuticals, comments continue to come in about experiences with the “new” Armour.

If I need to add more info or corrections, please use the Contact Me form at the bottom of any page on Stop the Thyroid Madness.

THIS PATIENT REVOLUTION for a better hypothyroid treatment is working! Desiccated thyroid brands which were almost extinct from low use are now seeing a comeback. Another comeback?? PATIENT HEALTH!! T4-only meds do NOT work, unless an elevator which only goes to the 5th floor of a 50 story building….works. My quote; my words.

p.s. See the post below about the importance of your potassium levels, and below that, how being hypothyroid can affect your liver, and my opinion of that fact with T4 meds vs. desiccated thyroid, which one comment disagrees with.  For the May 7th post, comments are still coming in about the “New” Armour. Express yours, and let’s hope that just raising it will do the trick, in spite of the loss of being able to do it sublingually as easy as before–a sad loss.

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

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.  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. Besides, there’s another pharmaceutical courting me at my door:  RLC Labs. Thank goodness there are other fish in the sea.

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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