Oops. Let’s not blow this out of proportion!

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.


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

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

  1. Sharon Janos


    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

    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

    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
    a) Armour Thyroid (thyroid tablets, USP), 4-grain
    b) Armour Thyroid (thyroid tablets, USP). 3-grain

    Product failed disintegration specification at 6-months.

  4. Cindy Abernathy

    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

    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?


  6. Judy

    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

    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

    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

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

  10. Judy Spangler

    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

    (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

    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

    (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:

  14. CC in Tucson

    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!

  15. SRP

    this is not a rumour … my doctor says there is none to be found. my doctor is THE armour thyroid doctor in central florida … it sure seems like he would know if there were some place to get it. i have had to take compounded synthetic for three months now and i am totally disabled by it. it’s a nightmare … i lost all the ground i had gained being on the armour … i can’t function. i’m going to call the lab in AZ and see what they say. i know these posts are old but it’s worth a shot.

  16. Heather Royer

    I am interested in Gail O’Connell’s situation as I too will soon be living in Thailand and concerned about the availability of armour thyroid overseas. I hope you find this message and would love to exchange emails.


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