Armour tags

When Forest Labs reformulated Armour earlier this year, they stated they increased the filler Microcrystalline Cellulose, and decreased the Sucrose (sugar). The tablets became impossible to do sublingually, and you have to wonder why they would change a quality that patients praised so heavily.  Positive opinion among patients for Forest Labs slipped several notches.

But the real cuckoo’s nest for many thyroid patients, who knew firsthand the life-changing benefits of natural desiccated thyroid, was a maddening return of serious hypo symptoms on the new Armour and subsequent new stress on their adrenals, sooner…or later! You can read several horror stories in the comments of the post below, or go here.

So patients turned to other alternatives: Naturethroid and Westhroid by RLC Labs…then when the desiccated thyroid shortages hit in the Fall of 2009, Erfa’s Thyroid, Compounded desiccated thyroid, and others. And there have been problems for some patients on most everything they switched to.  The LEAST problematic has been Erfa’s Thyroid, and the most problematic was Compounded.

So what has been the common thread in the most problematic desiccated thyroid products? CELLULOSE, a plant fiber, and more commonly known by the trade name Avicel. And what does fiber do in your stomach? Inhibits absorption. Armour’s cellulose was raised, and bamm…problems.  Compounded desiccated thyroid, with cellulose as a filler, has been problematic for many patients with a return of hypo symptoms,  especially if  it was Methyl Cellulose, a larger particle size product. But some have even had problems with compounded containing Microcrystalline Cellulose, the smaller cellular product. And a certain body of patients even had problems with Naturethroid before it became scarce. And Naturethroid uses cellulose as a filler.

Is this problem true with T3-only products? Yup. Patients have noted that generic T3 is far less effective than the brand name Cytomel (both Liothyronine Sodium)  And what filler it up to 70% in the generic T3?  CELLULOSE.  See the percentages here for Paddock’s generic T3.

Why have less problems been reported with Erfa’s Thyroid? Perhaps because it has no cellulose as a filler! See this list of ingredients, which STTM has been working on lovingly for a few years.

What does literature say about the use of Cellulose as a filler in medications? Plenty. Cellulose is from wood. Wood is fiber. And fiber in your gut affects absorption. From http://www.umm.edu/altmed/articles/fiber-000303.htm we get this:

* Dietary fiber has been reported to lower the blood levels and effectiveness of tricyclic antidepressant medications…Reduced dietary fiber intake increased the blood levels and improved symptoms in these patients.

* While fiber supplements may help to regulate blood sugar levels, they may also interfere with the absorption of anti-diabetic medications….Therefore, fiber supplements should not be taken at the same time as these medications.

* Taking soluble fiber such as psyllium with carbamazepine (Tegretol), a medication used to treat seizure disorders, may decrease the absorption and effectiveness of carbamazepine.

* Fiber in the form of pectin (from fruit) and oat bran reportedly reduces the body’s ability to absorb cholesterol-lowering medications known as “statins,”… and could lead to decreased effectiveness of these medications.

* Fiber supplements may reduce the body’s ability to absorb digoxin (Lanoxin), a medication used to regulate heart function.

* Clinical reports suggest that psyllium or other soluble fibers may lower lithium levels in the blood, reducing the effectiveness of this medication.

* In one clinical study, the fiber supplement guar gum reduced blood levels of penicillin.

Cellulose can clearly be a problem, especially when it’s ratio is too high as compared to the desiccated thyroid. So what can you do?

If you are using a compounded medication, strongly request powdered acidophiles, also spelled acidophilus, as your filler.  One gal states her compounding pharmacy uses powdered Ginger (but beware of too much Ginger if you have Mitral Valve Prolapse. It can cause palps if you take too much–my experience).  See what other fillers your compounder can offer.

Another possibility is Cellulase, an enzyme which helps the splitting and breakdown of cellulose, and which was proposed to me by Naturopathic student Stephanie Buist. Google “cellulase” and find supplements that contain it.  If it looks promising to you, I’ll be curious to read your experience with swallowing a cellulase supplement, then swallowing your problematic desiccated thyroid.

And leaning towards Erfa’s Thyroid can be a plus.

Have other ideas or comments about Cellulose in our desiccated thyroid? Use the COMMENT function below and let’s talk!

(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?

As a thyroid patient who was profoundly harmed by the use of Synthroid and Levoxyl in the treatment of my hypothyroidism, and as an activist who sees this same harmful truth with potentially millions of other patients, I find this recent news interesting.

But you gotta wonder if they will be wearing noise reduction headsets and ear plugs…or not…when it comes to the scandal of synthetic T4-only medications.  Will they?

Just today, the U.S. Department of Health and Human Services and the Food and Drug Administration (FDA) announced the Safe Use Initiative, “a program aimed at reducing the likelihood of preventable harm from medication use”.

Statements I gleaned from this initiative include:

1. Today, tens of millions of people in the United States depend on prescription and over‐the‐counter (OTC) medications to sustain their health—as many as 3 billion prescriptions are written annually. Too many people, however, suffer unnecessary injuries, even death, as a result of preventable medication errors or misuse.

2. Although FDA and many other stakeholders have been working to improve how the healthcare system manages medication risks in the United States, it is widely recognized that more needs to be done to protect the public from preventable harm from medication use.

3. Medications offer great benefit, but they come with risks. Whenever medications are not used optimally, risks of harm can increase significantly.

4. FDA proposes to identify, using a transparent and collaborative process, specific candidate cases (e.g., drugs, drug classes, and/or therapeutic situations) that are associated with significant amounts of preventable harm.

This initiative is actually far broader than what I gleaned above, and also involves self-abuse, exposure of dangerous medications to children, dire side effects, and more. Five areas are also specifically targeted:  Consumer medication information (CMI), Medication dosing devices, Acetaminophen toxicity, Alcohol-based surgical preps, and Medications in vials. You can read more in the fact sheet.

But if the FDA is going to do their job with this initiative, or do their job overall, you have to wonder if they will listen to and include the problems associated with being treated with a T4-only medication as experienced by millions of patients worldwide. Continuing symptoms of hypothyroidism while on this inadequate treatment is widespread and damaging for many, causing hands reaching deep in pockets to pay for numerous doctors appointments, besides antidepressants, anti-anxiety meds, blood pressure meds, statins, cortisol meds for adrenal fatigue, and other medications which we would have never needed, and would have been preventable, if we had been on natural desiccated thyroid like Naturethroid or Westhroid in the first place.

Many patients on thyroxine, T4-only medications will also report actual hospital visits due to the side effects of a poor treatment.

In other words, thyroxine aka levothyroxine aka T4 treatment has been an unsafe and harmful treatment, causing millions to suffer unnecessary injuries and side effects for over 50 years of its useless and popular use.  It fits the Safe Use Initiative. Or at the very least, it calls for the FDA to listen to patient experience with this lousy choice to treat hypothyroidism.

Listen to us, FDA. Listen and be wise.

P.S. See the blog post below about a genetic reason why so many do lousy on T4.

I confess that I hated my Chemistry class in high school, even if Mr. Bowen tried to make it interesting and favored the girls over the boys in class.  But lo and behold, one of those elements on the Periodic Table ended up having a significant role in all or our lives as thyroid patients: iodine.

Iodine can be found in every inch your body, but is especially prevalent in your thyroid, which makes it an interesting element for those of us with thyroid disease.  The active thyroid hormone T3 (triiodothyronine) is made up of three iodine molecules, and the storage hormone T4 (thyroxine) has four iodine molecules. In fact, without proper amounts of iodine, your thyroid wouldn’t even function well.

An optimal amount of iodine has also been shown to improve breast health, provide cancer protection, remove toxins like Bromide, fluoride, mercury etc…and in some cases, has helped thyroid patients either lower their dose, or even get off thyroid treatment. Thyroid patient Diana tells of getting off thyroid treatment due to iodine on the Stories of Others page.

***This Thursday evening on the Thyroid Patient Community Call on TalkShoe, we’ll have guest Stephanie Buist, owner of the Yahoo group Iodine and a 9-year thyroid cancer survivor who strongly feels iodine has been a huge factor.   We’ll explore how much iodine a person needs, the loading loading test, the best sources of iodine supplementation, whether you need iodine, as well as controversies with iodine use, including Hashimotos disease or bad reactions.  Times for the call are 6 pm Pacific, 7 pm Mountain, 8 pm Central and 9 pm Eastern. You can listen right on your computer, or call to talk directly to Stephanie and Janie. Join us!

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Sheila Turner of TPA-UK  (Thyroid Patient Advocacy-UK www.tpa-uk.org.uk) is starting the ball rolling on something very interesting:  they have contacted a lab in the UK who will do a qualitative analysis of the old Armour vs. the new reformulated Armour to get a breakdown of the ingredients, and potentially give us an idea WHAT is causing thyroid patients to have a return of their hypothyroid symptoms since Forest reformulated Armour in 2009.

However, says Sheila, this will cost in the region of £600 to £700 (approximately $1100).  Says Sheila, “If there are enough patients who are willing and able to help raise the funding required by giving whatever we can afford, we could finally get the answer as to which changes have been made in the new formula and whether this includes changes in the active (as some have suggested) and the inactive ingredients and put this baby to rest once and for all.”

You can contact Sheila at the above website and make a pledge.  As I write this, they have already have £100 pledged.

UPDATE: Stephanie above has agree to be the ‘Pledge and Money Collector’ for the lab work needed to analyze the old vs new Armour . She can be contacted at ladybugsandbees@sbcglobal.net

Sometimes there is a silver lining with the storm cloud of backordered US desiccated thyroid.

Erfa, the makers of the Canadian version of natural desiccated thyroid, simply called “Thyroid”, has recently announced that the FDA is not requiring the extensive FDA Form 1572 from US citizens and their doctors when they fill their prescriptions from Erfa directly. i.e. it’s now a lot easier to get your prescription filled directly from them.

http://www.erfa-sa.com/thyroid_usa.htm

And those who have started to use Erfa’s Thyroid report being quite pleased. A cherry on top is that Thyroid has that old sweet taste we used to all like with the old Armour, and it can be done sublingually as well! You can see the ingredients here.

Also, I am continuing to get emails from patients that both Armour and Naturethroid is starting to appear on pharmacy shelves, even if in small quantities.  I’m personally not too excited about Armour reappearing if Forest continues to make the reformulated version. Just too many patients reporting a return of hypo symptoms, even when they raise it, plus new symptoms of undertreatment and/or challenged adrenals thanks to the reformulated version. Sad. Oh how we will all miss the old Armour.

In the meantime, here are options for thyroid treatment we all have until we see a good return of desiccated thyroid, including Naturethroid and Westhroid. They are all far, far better than being on T4 alone like Synthroid, Levoxyl, levothyroxine, et al. You’ll also note compounded thyroid, which can be a good option, and you can read about on a recent blog post.  Australians happily use compounded in their own country. Any option you and your doctor choose may mean a readjustment by your body, by the way.

Want to talk to other patients on how they are dealing with the shortages? Join the Coalition for Desiccated Thyroid.  Or if you simply need patient feedback about your hypothyroidism, go to the Talk to Others page.  Remember that no patient group is meant to be a substitute for your relationship with your doctor.

**The next Thyroid Patient Community Call will be held Thursday Oct. 8th on TalkShoe, and our topic will be iodine and your thyroid with patient expert Stephanie Buist. Come join us and listen right on your computer, or you can also talk live to Stephanie or Janie with your questions.