• +Audience
• Armour
• naturethroid

In case you are mis­sing com­ments on my pre­vious posts, there is a poten­tial solu­tion to the pro­blems encoun­te­red with both the refor­mu­la­ted Armour by Forest Labs, and the refor­mu­la­ted Natu­reth­roid by RLC.

Namely, by either crushing your tablet with a mor­tar and pestle, or che­wing it up in little pie­ces, patients are star­ting to report far bet­ter symp­tom relief!! i.e., this pro­cess is pro­bably brea­king down the ridi­cu­lous coa­tings and cellu­lose and allo­wing your body bet­ter access to the desic­ca­ted thy­roid within.

And if you just can’t sto­mach the pul­ve­ri­zed pill method, add a touch of honey to the pow­der, and lick it all up.

Let us know how it works for you!

Want to see the newest Ques­tion & Ans­wer page on STTM? Go here.

PREVIOUS BLOG POSTS:

To read my Edi­to­rial Res­ponse, go here (or if you are rea­ding this on the blog, right below)
To read my infor­mal sur­vey on the new Armour, go here.
To read UK Sheila Turner’s Guest post on those who cri­ti­cize self-treatment, go here.
10 rea­sons thy­roid patients are frus­tra­ted, angry and sick, here.

It’s been about a year since Armour desic­ca­ted thy­roid, a very popu­lar presc­rip­tion natu­ral thy­roid pro­duct on the mar­ket for deca­des, was refor­mu­la­ted. Forest Labs sta­ted there were two chan­ges: the rai­sing of cellu­lose, and the lowe­ring of sucrose.

Why did they do this? It could be strongly rela­ted to the fact that in late 2007 through 2008, patients who used the 3 grain tablets repor­ted they were sud­denly and enti­rely inef­fec­tive. So, many of us sur­mise that Forest was attemp­ting to “improve” (cough) their product.

Says one of those patients:  I had switched to the 3 grain tablet months before to save money and I used my pill cut­ter to cut it in half.  Then around Novem­ber, my work pants were get­ting tight and I would come home tired, achy and weak. It didn’t take me long to figure out that Armour in the 3 grain was now like a sugar pill!

In the mean­time, Forest brought out the newly for­mu­la­ted Armour, & patients who finished their old batch star­ted the new batch. And since then, it appears a large body of patients have run as fast as they could to Natu­reth­roid, or com­poun­ded, or T4/T3 or Erfa. The rea­son: a return of for­mer hypo symp­toms on the “new” Armour.

I have com­ple­ted an infor­mal sur­vey with 24 indi­vi­duals res­pon­ding, and asked the follo­wing ques­tions. After each ques­tion, I give a sum­mary of the answers.

1. How long of doing well occu­rred on the newly refor­mu­la­ted Armour before you star­ted to notice that you weren’t doing well?

Most ans­wers are in the area of 2 – 3 months, with three saying a month, one 4 months, and three sta­ting a few weeks. And com­pa­ring this to com­ments we’ve been seeing for the past year on patient groups, it’s com­mon to feel good at first, but to crash within that 2 – 3 months.

2. What clued you in that you weren’t doing well on the new Armour?

The ans­wers are all over the map: fati­gue and exhaus­tion, hair loss, brain fog, weight gain, slee­ping pro­blems, cons­ti­pa­tion, achi­ness, depres­sion, hor­mo­nal pro­blems, moo­di­ness, dry skin/elbows/thumbs and crac­king skin, fla­king fin­ger­nails, heart irre­gu­la­rity, for­get­ful­ness. Five report skin brea­kouts simi­lar to poi­son ivy.  Fati­gue and hair loss were the most com­mon answers.

3. Did you try rai­sing it? What were the results?

The majo­rity tried rai­sing it, and results were: no results; barely made any dif­fe­rence: more energy but skin was a mess. The majo­rity said nothing hap­pe­ned. Two dou­bled it with no sig­ni­fi­cant results.  Two deve­lo­ped fast heart rate with no impro­ve­ments elsewhere. One had to lower it because of a very low TSH. One sta­ted she rai­sed it to get her labs back up to where they were before…with little impro­ve­ments.  And one said it made her too hot to con­ti­nue rai­sing it.

4. Did you try adding T3 to it? What were the results?

All said no. One said she tes­ted here RT3 ratio and it was 11, which is bad.  One sta­ted she asked her doc­tor for T3; he said no. I’d sure like to find someone who did add T3 who could tell us the results.

5. Did you do anything else to try and make the refor­mu­la­ted Armour work, and did it help?

All repor­ted nothing hel­ped enough.  Many sta­ted their doc­tors tes­ted for other pro­blems, ran­ging from heavy metals, low iodine, B12 – the lat­ter hel­ped one gal’s tin­gling. One sta­ted her doc put her on Apro­to­col for the diges­tive tract which hel­ped the cons­ti­pa­tion but nothing else chan­ged. One added com­poun­ded desic­ca­ted thy­roid to her Armour — it didn’t help. One gal tried Thyro-care, which hel­ped. But she and two others report get­ting a poison-ivy like skin rash on the new Armour.

Currently, we see newly diag­no­sed patients put on the new Armour, and vete­rans can’t help but won­der what will hap­pen to them.

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On my April 17^th blog post, read 10 rea­sons thy­roid patients are still frus­tra­ted, angry and sick. That is follo­wed by the April 19^th blog post Should thy­roid patients avoid self-treatment at all costs, with an inte­res­ting and strong Guest Post by Sheila Tur­ner of TPA-UK and a good follo­wup to the for­mer 10 rea­sons post.

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If you appre­ciate the infor­ma­tion you receive from this patient-to-patient web­site, please con­si­der making a dona­tion to sup­port the hos­ting costs for this Stop the Thy­roid Mad­ness web­site. The icon is on the lower right.

(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.

*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.