• 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?

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

* The extre­mely hip and sophis­ti­ca­ted STTM t-shirts are half price! I love sales! Spread the word!

* Pre­fer STTM in book form with more detail? You can read about it here.

*Need options for thy­roid treat­ment during the current shor­ta­ges due to demand being grea­ter than supply? Go here.

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.

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

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 14^th, 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℗(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 2^nd post Trying the Newly For­mu­la­ted Armour? Before that, you can read my May 7^th post Why the party is over with Forest Phar­ma­ceu­ti­cals and the current 37 com­ments.  And espe­cially power­ful is the April 28^th 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.