thyroid patients 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!

If you have been keeping up with my posts, you’ll know that thyroid patients have been facing a shortage of desiccated thyroid for many weeks, probably due to sharp increased demand i.e. thyroid patients have been finding out how lousy T4-only treatment like Synthroid has been for them, and how much better desiccated thyroid is.

That demand became especially true after a reformulation of Armour by Forest Labs in 2009 drove patients to RLC’s Naturethroid and Westhroid. The “new” Armour caused a return of hypo symptoms plus new maddening ones, including palpitations and sleep problems never seen before.  As Julia Roberts said in the 1990 movie Pretty Woman: Big mistake, Big, Huge.

In addition, it didn’t help when Time Cap Labs, a pharmaceutical which made plenty of desiccated thyroid for other pharmaceuticals, stopped production after being contacted by the FDA. This action was probably in line with their aims to make long-term unapproved drugs become approved, even if the timing was incredibly stupid.

As all the above was happening, panic ensued!

We’ve heard all varieties of negative presumptions from thyroid patients about what caused the shortage, including an FDA conspiracy and an overt belief that desiccated thyroid is about to be removed.  Patients have threatened law suits, blamed pharmaceuticals, and/or sent numerous letters to FDA pleading to keep desiccated thyroid as if it was to be gone tomorrow. Even I, at first, fell in line wondering about the FDA.

But it started to dawn on me, as it has others, than we have been jumping the gun, not giving enough emphasis to facts and reason.

And finally, facts and reason are starting to appear on blogs and groups:

1) Yes, Forest Labs, the makers of Armour, and RLC, the makers of Naturethroid and Westhroid, state they have not been contacted by the FDA. We have no reason to disbelieve them!

2) Yes, RLC is working hard to catch up, as is American Laboratories, both state. We also have no reason to disbelieve them!

3) Yes, thyroid patients who know the superiority of desiccated thyroid have always been there to support them. Glad to see that recognition in blog and group postings.

4) Yes, as health writer Mary Shomon has stated, information-gathering, brainstorming, and communicating with our doctors is a good thing to be doing.  That is contrary to making panicky negative predictions about desiccated thyroid,  rallying for law suits, and feeding ideas to the FDA that may not be there in the first place.

5) Yes, we need to put energy in letting the world know about the superiority of desiccated thyroid treatment in our lives. That is where our power lies in the face of clueless Endocrinologists and their equally-clueless medical boards like AACE.

6) Yes, we need to listen to and support the pharmaceuticals and laboratories which give us the desiccated thyroid we need. It’s they who have to walk the line with the FDA. Let’s listen to their cautions and support them.

Strangely, there are still misconceptions being reported by patient blogs and posts:

1) That we don’t know what caused the shortage. But we do! Demand is as logical as it gets.  All of us have succeeded in getting the word out! That is exactly why I created STTM in the first place!  And by emails I get every week, it’s clear that it’s been working.

2) That groups like the Coalition for Desiccated Thyroid (CDT) have a wait-and-see attitude. That is as silly as saying STTM wants to ban T4 or encourages self-treatment. There are simply some thyroid patients who don’t agree with the extreme panic and negative presumptions that have been going on, and want more reason in our pro-activity!  Patients have been encouraged to spread the word in any way possible about the superiority of desiccated thyroid and how it’s changed lives, NOT to feed dire negative predictions which only end up giving ideas we don’t want to give! You are most welcome to join the Coalition above in addition to other groups.

Good for patients and advocates alike for putting more reason and fact in this situation.

I’m also glad to see some strategic, pro-active behind-the-scenes work going on as a just-in-case line of activism. That is the way it should have always been–a plan for action “just in case”, not dire predictions and fear mongering as if it all WAS going to happen.

We’ll get through this, folks. Here are options for thyroid treatment in the meantime. And if you want to talk to other patients, join our thyroid patient Community Call this Friday. Details are found in the September 7th blog post.

On the August 19th blog post, you can read about the only North American manufacturer of natural porcine desiccated thyroid called American Laboratories (ALI). ALI sells to distributors who in turn pack it up in smaller quantities which go to those who create desiccated thyroid products.

I just got off the phone again from Kenny Soe­joto, the Chief Ope­ra­ting Offi­cer at ALI.  And the news couldn’t be better.  ALI is working hard to catch up and is currently shipping to all their customers.  Yes, they are still in a backorder situation due to demand being greater than supply in 2009, but work is in progress, shipments are being made to all, and they hope to see some major catching-up in two months or so.

And his most important comment? “If we had FDA issues, we wouldn’t be producing”. i.e. everything is going fine.

In the meantime, there seems to be two areas of success right now with getting your desiccated thyroid prescription filled:  from Canadian pharmacies, and from Compounding pharmacies.  Hang in there. We’ll get past this.

Join us next Friday for our next thyroid patient Community Call via Talk Shoe. See the blog post right below this for information.  Below that is information about the Coalition for Natural Desiccated Thyroid, an independent group working alongside Mary Shomon’s efforts, as well.

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

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Wish you could talk to others about relevant facts concerning the current shortage, the FDA’s actions with Time Caps Labs, DESI and the New Drug Application, clinical trials, and related concerns? Have important information to share?

A new group has just been created to work alongside other groups, including save natural thyroid. Smartly called the Coalition for Natural Desiccated Thyroid, it  represents unity of concern and is created for patients, advocates, medical professionals, representatives of pharmaceuticals who manufacture desiccated thyroid, or anyone with an interest in the four aims of this group:

1) Sharing of factual information concerning natural desiccated thyroid
2) Discussion of current issues related to desiccated thyroid
3) Unity among all concerned
4) Coordination of grassroots action where needed.

The discussion, support and action of this group does not limit itself to any one group, advocate, website or forum, and welcomes any mention of information from websites, advocates, medical professionals or etc. which/who post about or have the same concerns as the aims above.

Join the group here: http://health.groups.yahoo.com/group/CoalitionForDesiccatedThyroid

As thyroid patients are not only in angst about a complete shortage of desiccated thyroid in the US, we all have questions and concerns about out future with no definitive answer.

For example, we wonder if the FDA may be  requiring clinical studies from pharmaceuticals who make desiccated thyroid to prove that it’s safe and effective (in spite of the fact that patients have been using it safely and effectively for 110 years.  Nope, we don’t count. Amazing, isn’t it?) And we wonder: if studies are required, will they be able to afford the studies, which are quite expensive? Will desiccated thyroid continue to be available while the studies go on? And more uncomfortable questions.

The FDA recently replied to a question by thyroid patient Catherine when she asked about the shortages and here’s their reply:

Dear Catherine:

Thank you for writing the Division of Drug Information, in the FDA’s Center for Drug Evaluation and Research.

We understand your concerns regarding the availability of natural desiccated thyroid products.  FDA has NOT taken class action against unapproved thyroid products resulting in a shortage.  If a company discontinues manufacturing of an unapproved product, that is a business decision made by the company.

Please refer to the ASHP Shortages website for a listing of desiccated thyroid products that remain available:
http://www.ashp.org/Import/PRACTICEANDPOLICY/PracticeResourceCenters/DrugShortages/GettingStarted/CurrentShortages/Bulletin.aspx?id=459

We have contacted the companies and RLC (manufacturer of West-Throid and Nature-Throid) is in backorder for all strengths and products for the next 90 days.

Major has the 60mg and 120mg available of their “generic” desiccated thyroid product.  They report increased demand as the reason for their backorder for the other strengths.

Forest reports they have the 120mg, 240mg, and 300mg strengths available for their Armour Thyroid products and they report increased demand as the reason for the backorder on their other strengths.

If you and your healthcare provider determine that one of these thyroid products is appropriate for you, you can provide the NDC numbers listed on the ASHP website for these products to your pharmacist so they can order for you.

Best regards,
Drug Information SH
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

The interesting thing about the above is that it implies that Major Pharmaceuticals is just on backorder, which goes completely against what patients have reported elsewhere.  What’s going on there? Are they using old knowledge? And the larger sizes of Armour? Is anyone finding that at the pharmacies right now? Very curious. Interesting the comment about RLC, the makers of Naturethroid.  And the link to shortages is interesting, though from the end of July.

Whatever the answers are, if you need a treatment to get you through this difficult time, here are options for thyroid treatment. And it still may be a very good idea to inform your congresspersons of our situation…just in case. See my blog post below.

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