January 11, 2008

A very ove­rreac­tive rumor is being star­ted as I type this about the FDA and Armour, and I think this whole topic needs to be leve­led out. The rumor is as follows:

1) The FDA has stop­ped manu­fac­ture of all grand­fathe­red drugs like Armour.
2) Armour will no lon­ger be avai­la­ble at your local pharmacy

i.e. it’s being ban­ned, dis­con­ti­nued, taken off the mar­ket, got­ten rid off…you name it. 

Now first let me cla­rify that all are totally and com­ple­tely false. Forest Labs is still making Armour, and you can also find Armour at your local phar­macy, even if cer­tain strengths are easier found than others. 

Here is what is going on: In the January-February issue of the 2007 (i.e. a YEAR AGO) FDA Con­su­mer Maga­zine, an article came out by Miche­lle Mea­dows tit­led The FDA Takes Action Against Unap­pro­ved Drugs. But this is NOT new news. This is based on the June 2006 release gui­dance by the FDA, called Mar­ke­ted Unap­pro­ved Drugs — Com­pliance Policy Guide. What the FDA is doing is wor­king to get unap­pro­ved drugs meet their appro­val guidelines. 

What is an unap­pro­ved drug? For one, they are those drugs which were around before the FDA (Fede­ral Drug Admi­nis­tra­tion) came into exis­tence in 1938, and these drugs were ‘grand­fathe­red’ in with the sub­se­quent FDA-approved drugs the­reaf­ter. (Armour is an exam­ple. Synth­roid was too until it did what it took to be appro­ved in 2002) Other exam­ples, as explai­ned in the January/February 2007 article, are when only one com­pany may have appro­val to mar­ket a drug, but other com­pa­nies are ille­gally mar­ke­ting their ver­sions of the drug without having gone through the FDA’s appro­val pro­cess. Another sce­na­rio is that a com­bi­na­tion of ingre­dients is appro­ved by the FDA, but a com­pany is mar­ke­ting a sin­gle ingre­dient without approval. 

The article also clearly sta­tes: Before pur­suing regu­la­tory action against unap­pro­ved drugs, the FDA plans to con­si­der the effects on the public health, inc­lu­ding whether the pro­duct is medi­cally neces­sary. The agency recog­ni­zes that some unap­pro­ved the­ra­pies offer bene­fits. An exam­ple is Phe­no­bar­bi­tal, a drug used to con­trol sei­zu­res. In some cases, FDA action requi­ring drug appro­vals will be gra­dual to avoid shor­ta­ges of medi­cally neces­sary pro­ducts. In other words, whe­ne­ver the day may come that Forest Labs is asked that Armour meet the regu­la­tions of the FDA, the pro­cess will be gra­dual and Forest will be given a fair dead­line to do what it takes.

Kathy, a phar­ma­cist with Forest Labs, reminds us that Armour has never been asked to go through that pro­cess (or they may not be admit­ting it yet so they can go through it in peace.). And if the day comes, they will do what it takes. Armour is a safe and life-giving pro­duct. And you bet your boo­ties that even if it loo­ked threa­te­ned some day, there would be a huge upri­sing from patients to stop it. But that’s not going to hap­pen, just as it was for Synth­roid where Abbott labs did what it took to be appro­ved, and succeeded. 

So, take heart: everything is fine. Armour is still being made. Your phar­ma­cies still have it, even when some strengths are easier to come by than others. And I’ll keep you infor­med. And remem­ber: I’ve always told you to stock up on your desic­ca­ted thy­roid pro­ducts any­way. :)

p.s. The root of the rumor comes from a recent recall by Forest Labs con­cer­ning its 3, 4 and 5 grain tablets, which had a 6-month potency pro­blem, and a misun­ders­tan­ding about it’s impli­ca­tions by indi­vi­duals. Those tablets are currently sche­du­led to be out again by the end of January.

http://www.fda.gov/fdac/features/2007/107_drug.html
http://www.fda.gov/cder/guidance/6911fnl.pdf

***Want to spread the word and be your own thy­roid patient advo­cate? Get your t-shirt here.

This entry was posted on Friday, January 11th, 2008 at 10:38 am and is filed under Armour. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

14 Responses to “Oops. Let’s not blow this out of proportion!”

  1. Sharon Janos said:

    Feb 12, 08 at 1:15 pm

    Janie,

    Thanks so much for the web­site. I am a 48 year old female who had most of my thy­roid remo­ved in 1998. It lite­rally took 6 years to regu­late my levels and that only hap­pe­ned after hea­ring of armor thy­roid. I found a great doc­tor who wor­ked with me and I now take Levothy­ro­xine and Armour together. I have just been diag­no­sed with severe ane­mia and was rea­ding your site on Ferri­tin levels. Mine are vir­tually non exis­tent and everything else is extre­mely low. Saw my great doc today and plan­ned a course of action. I will be taking iron in inc­rea­sing doses each week. Thanks again for get­ting the word out!!!

  2. Gail OConnell said:

    Feb 15, 08 at 6:20 pm

    Hello, and thank you SO much for your web­site! I can’t even tell you the num­ber of times I’ve check it. I always find a gem that I can use to help me to unders­tand my con­di­tion and work “with” my doc­tor in hel­ping me get well.

    I live in Thai­land and need to get my thy­roid medi­ca­tions brought to me from the US for six months at a time. Up until January, I was on a “gene­ric” Amour, but in January, I star­ted on the real one. (The presc­rip­tion was filled last Novem­ber) How can I find out if the meds I have are of the lot that was reca­lled? Do I need to con­tact my Phar­macy? (Yes)

    The rea­son I was chec­king the site out today is because since I have star­ted Armour, some of my symp­toms are retur­ning. I am also loo­king at the pos­si­bi­lity that it may be my adre­nals too…

    Again, thank you for the won­der­ful web­site and all your hard work!

  3. Michael E. Doyle, MD said:

    Feb 16, 08 at 4:01 pm

    Thanks for the great website.

    Please empha­size to your rea­ders that the recall does not appear to have anything to do with potency. It looks like the FDA felt that the pills were too soft after six months on the shelf – this is very dif­fe­rent than a pro­blem with potency or dose con­sis­tency. I’ve also never seen this com­plaint from an actual patient taking Armour thy­roid. See below excerpt from your link–

    Forest Phar­ma­ceu­ti­cals Inc has reca­lled Armour Thy­roid (thy­roid tablets
    PRODUCT
    a) Armour Thy­roid (thy­roid tablets, USP), 4-grain
    b) Armour Thy­roid (thy­roid tablets, USP). 3-grain 

    REASON
    Pro­duct fai­led disin­te­gra­tion spe­ci­fi­ca­tion at 6-months.

  4. Cindy Abernathy said:

    Jul 27, 08 at 4:07 pm

    Its ama­zing the depth that the rumor has gone, that Armour is going to be dis­con­ti­nued. Yes­ter­day, 7/26/08 I went to the Tar­get Phar­macy and was told that there were no 60 mg left, so they gave me dou­ble the num­ber of 30 mg. The phar­ma­cist went on to say that “they arent going to make Armour any­more”. I then said “No ma’am, it’s a rumor. You can check the Forest Phar­ma­ceu­ti­cal web­site.…” and she cut me off and said “No…our warehouse has in its com­ment sec­tion a note saying that many strengths are out due to the fact that Armour is being dis­con­ti­nued. Our warehouse and com­pu­ter sys­tem says that”. I just shook my head and said…its ama­zing that a rumor could have wor­ked its way into regu­lar busi­ness ope­ra­tions like that. 

    I left, with them thin­king I was an idiot…and me thin­king the same thing about them. I hope it is me that is right.

  5. Kathy said:

    Aug 11, 08 at 11:42 am

    I note that this article was done on 1/11/08 and there was a sta­te­ment that the recal doses “were sche­du­led to be back again by the end of January.” My Doc recently gave me a presc­rip for 3 grain and my pharm sta­ted that they are stilll on recall. What goes?

    Kathy

  6. Judy said:

    Aug 13, 08 at 11:10 am

    This is what I am being told too. I have chec­ked at Target,Walmart and Dillons all 3 have given me the exact same story. I got no res­ponse when I wrote Forest Pharmaceutical.

  7. Kathryn said:

    Oct 02, 08 at 6:08 pm

    For the last seve­ral months, my phar­ma­cist never has a month’s supply of 120 Armour thy­roid for me. He always “owes” me a dozen or more pills — he says not too many peo­ple use it much any­more and he can’t seem to keep it. Yes­ter­day, 10/1/08, I went to claim the amount he owed me, thin­king that surely he’d got­ten it in in the past 3 weeks. He didn’t have my dosage, but was able to give me a les­ser dosage and ins­truc­ted me on how many to take to equal it out. He also said that it appea­red Armour was going to be pha­sed out, that it was a natu­ral thy­roid medi­ca­tion and the demand was so low that the manu­fac­tu­res were going to quit making it! This was the first I’d heard of this until I got on the web tonight! For the record, I star­ted out on Synth­roid years ago for awhile, and I do so much bet­ter on the Armour. I cer­tainly hope they don’t quit manu­fac­tu­ring it. But I can’t figure out why he has so much trou­ble get­ting it for me.

  8. Wynnell Nowell said:

    May 20, 09 at 5:47 pm

    I am a Senior Citi­zen on Medi­care and a Scott & White (a Hos­pi­tal,& Cli­nic major Sys­tem in Cen­tral Texas) Health Plan for a sup­ple­ment (HMO, I pre­sume?). They have just denied me the Armour as it is not on their list of FDA appro­ved meds. I have gone through the Free Meds as adver­ti­sed (by Mon­tel Williams on T.V. for a long time now) and am hoping (after having sent my $10.00 fee for enroll­ment, any age – one time fee for as long as you need the med – any or all one needs) if you make under $42,000 per year for an indi­vi­dual. When appro­ved — soon as pos­si­ble I hope – I will be sent the meds via my my endo– I only lear­ned this news less than two weeks ago and I am almost out. They sent a let­ter –snail mail– that I was not going to be allo­wed but the one prescp­tion on May 1 and no more-period. I will be out com­ple­tely June 1st and since I have had my com­plete thy­roid gland remo­ved (Can­cer), I was deeply dis­tur­bed as Armour has been so great for me. So what about this?

  9. gina said:

    Jul 17, 09 at 10:27 am

    Janie, both the links in your post are dead. (Stu­pid FDA; that info should NOT just disappear!)

  10. Judy Spangler said:

    Aug 14, 09 at 1:58 pm

    I just recei­ved a call from Medco advi­sing that all “Natu­ral” thy­roid manu­fac­tu­ring has stop­ped, but wouldn’t/couldn’t tell me why.
    This wasn’t just Armour it was ALL manu­fac­tu­rers.
    So, what is going on.….…

  11. Laura Rucinsky said:

    Sep 04, 09 at 5:14 pm

    (Laura, go here: http://www.stopthethyroidmadness.com/options-for-thyroid-treatment)

    I have been out of my thy­roid medi­ca­tion for seven days now. My hair is falling out, I am irri­ta­ble, shaky, have brain fog, no energy and feel like crap. I have been on seve­ral medi­ca­tions for hypothy­roi­dism. All of the medi­ca­tions gave me the runs – to the bath­room. I was put on Amour Thy­roid about a year ago and my life was back to nor­mal. Now, I’m sick all over again. I’ve called and been to every phar­macy in town. No one has this medi­ca­tion and the phar­ma­cies tell me the same thing. It has been taken off the mar­ket and is not going to be avai­la­ble again. Levoxyl and synth­roid do not help me and I can­not func­tion, for run­ning to the bath­room. Someone, please help me.

  12. Jill T said:

    Sep 09, 09 at 7:38 pm

    I just got off the phone with a Medco Phar­ma­cist who con­fir­med why I have not been able to find Armour at any of my local phar­ma­cies. Armour manu­fac­tu­rer Forest has stop­ped pro­du­cing the drug in the wake of the FDA “revie­wing the effec­ti­ve­ness” of Armour. No Armour in southern Sili­con Valley.

  13. Jen M said:

    Sep 25, 09 at 6:27 pm

    (From Janie: Hi Jen. They haven’t taken it away. It’s all on bac­kor­der, and we know that some is tric­kling back into phar­macy shelves…)

    Had to call 20 sto­res to find Armour. I took the last of what they had. Inte­res­ting infor­ma­tion I recei­ved with my
    medi­ca­tion. The paper that comes with your RX explai­ning it’s uses etc… In capi­tal let­ters it said “NO COMMON SIDE EFFECTS HAVE BEEN REPORTED” For as long as this medi­cine has been around, How on earth can they just take it away like this? It’s all about the FDA and the Govern­ments wan­ting to make money and direc­ting us towards another drug that they will make a pro­fit on. Wake up peo­ple it is another con­trol issue with the govern­ment. Shame on them for taking our lives in their hands as they do with everything. YOU KNOW THEY WOULD NEVER DO THIS WITH PAIN MEDICINE OR WITH VIAGRA.…..
    Laura Rusinsky, I hope you have found some Armour!!! I’m so sorry you are going through this and I know it will be soon I will be dea­ling with the same!!! I really hope you are OK!! Makes me furious!!!! Try the Cana­dian Phar­ma­cies if you can.Just keep calling every phar­macy you can!
    Check out this article:
    http://www.emord.com/events/speeches/fda_violation.htm

  14. CC in Tucson said:

    Oct 05, 09 at 11:25 am

    This is for Laura Rucinsky! (and others)
    Try Presc­rip­tion Lab in Tuc­son, AZ (520) 886‑1035
    They can com­pound any strength for you if you have a presc­rip­tion from a doc­tor. Good luck!

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