• Armour
• desiccated thyroid
• fda
• shortages of desiccated thyroid

(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?

Just spoke with Diane Blecha, who serves as a moderator and patient advocate on the NTH groups.

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.

Word has trickled down to me from a few patients and emails that even Naturethroid is getting harder to come by at pharmacies because of the extreme demand on RLC Labs.

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.

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