Did the FDA Order Generic Armour Thyroid Maker to Stop Production?

Here is an article that was posted in a note on a friend’s facebook page. It didn’t have a source so I googled the title and found the same article here: http://www.healthfreedom.net/index.php?option=com_content&task=view&id=878

I also found this on the Care2 site: http://www.care2.com/news/member/410531040/1237339

So hold tight and look online to see if you can find anything else about this – it is surprising that there isn’t a ton out there on this yet, so it’s possible this will turn out to be just some rumor.

You might consider calling your doctor if you are worried about the supply of your thyroid medication, I have heard that several areas are having shortages of various types of natural thyroid medications. More on that is on the Synthroid Haters blog referenced at the bottom of this post.

FDA Attacks Natural Thyroid Millions Depend On
We have learned that Time-Cap Labs, producer of a generic version of the brand name drug Armour, a natural and bioidentical thyroid replacement, has been ordered by the FDA to stop production. The FDA has decided to classify the company’s product, available for over a century, as an unapproved new drug. Since the new drug approval process is prohibitively expensive for a non-patentable substance, the FDA is in effect banning the natural product. The purpose? Presumably to protect the profits of other, inferior drugs that have been FDA approved.

According to statistics by the American Association of Clinical Endocrinologists and other medical organizations, approximately twenty-seven million Americans have a thyroid disorder. Thyroid consumer advocate Mary Shomon projects that 2 million of these patients take either Armour Thyroid or a generic equivalent.

Armour and other “whole” natural thyroid preparations (including Westhroid and Nathroid as well as Time-Cap Lab’s Thyroid) are bio-identical, complete hormone preparations, containing “T4” “T3” “T2” and “T1” in the same proportions made by the human thyroid.

The FDA approved preparations Synthroid (T4), Cytomel (T3), and Levethyroxine (T4) include bio-identical molecules, but are not complete or totally bio-identical as they do not contain “T2” or “T1”. It’s no wonder so many people feel much better with the balanced natural products that have been available for generations.

As famed physician Dr. Jonathan Wright observes: “Natural thyroid has never killed or severely harmed anyone since its first use in the 1890s, prior to the FDA itself. It is a mainstay not only in the treatment of hypothyroidism but also in ‘healthy aging’ therapy. That the FDA should even be thinking of requiring a new drug approval for a safe, 100 plus year old natural treatment is outrageous.”

We will report further as soon as we confirm more of the facts, and as always, we’ll let you know how you can get involved.

September 1, 2009

I don’t usually have a reason to write much about thyroid medication or hypothyroidism on this blog, but considering that I have to take daily thyroid medication and have been doing so since I was 22, I have been worried about the shortages that are going on right now with various natural dessicated thyroid treatments. If the FDA really did tell a producer of a necessary drug to stop production and file an NDA, I am curious what the exact reason was. This may not be so pretty for all the patients who suddenly have to try and switch to something else and have problems if they don’t find out until their prescription needs to be refilled.

I know after just a couple of days without thyroid medication I start getting very tired, and if you take nothing it could eventually cause your body to completely shut down (not sure how long this takes, but that’s what I was told. Who knows?? Anyone out there know?).

Many patients taking antidepressants etc. are also misdiagnosed and have underlying thyroid problems which are also exacerbated by the psychotropic drugs. Hypothyroidism is a major underlying cause of depression.

If you have hypothyroidism and take Armour Thyroid, it is probably time to ask about a different medication. I recently started taking NatureThroid instead of Armour. I checked at the pharmacy tonight and locally, my pharmacy has plenty of NatureThroid but has been completely out of Armour for quite some time.

Here is a blog that follows the Thyroid news all over the web and covers news from STTM and Mary Shomon: http://synthroidhaters.wordpress.com/ (To explain the title of the blog: in a nutshell, many patients have inadequate symptom relief from Synthroid and choose to go on a medication with more than one type of thyroid hormone).

12 thoughts on “Did the FDA Order Generic Armour Thyroid Maker to Stop Production?

  1. My mother has taken armour thyroid for years. She began after the birth of her sixth child. I am sure it helped her postpartum periods as she ultimately had nine children.

    I took armour thyroid after the birth of my fourth child and it helped my postpartum period also. I was able to work and care for my newborn son.

  2. September 19th – I’ve just found out about this from rite-aid when going to fill my wife’s perscription.

    I can NOT believe that my wife’s doctor, who specializes in thyroid conditions, didn’t call or send a note indicating that something was going on with this medication. I think that is very, very irresponsible.

    1. I agree with you. It is incredibly irresponsible. A really weird thing happened to me. First I was told several times that my Armour Thyroid was not available or that it was on back order. Then I started reading online about the shortage so I had my doctor call in a prescription for NatureThroid. So, when I went to get that filled, I was told it was not available and I would have to wait for a back order. We said OK and I started taking my back up supply of old Synthroid. So then, when my husband went to pick up the NatureThroid, the pharmacy asked if I would like to switch back to Armour instead because it was available. He said no, we wanted what the Dr. prescribed.

      Basically, the Armour had stopped working for me, and I was happy to switch, but once they saw that I was about to get my NatureThroid, they suddenly had it…

      Later on I went to pick up a full supply for the next month and I decided to ask about its supply because there were rumors that all the alternate types of natural thyroid medications were having shortages as well. I was told by the pharmacist that they had no Armour but had plenty of NatureThroid, and that they had been completely out of Armour for months.

      I would be willing to bet that certain people would like us all on Synthroid, which doesn’t seem to work very well for many, many people.

      It’s all a little bit fishy to me. Also, why would the FDA order someone to stop making generic Armour all of the sudden? Was your wife’s generic still working well? Seems that the reformulation of Armour was the problem. I wonder if they also reformulated the generic or if it was left alone and thus working well? There’s a reason for the FDA to ban it… Do I sound cynical?

      Oh, by the way, the FDA seems to be approving electroshock machines as safe and effective without any documentation or proof of safety whatsoever (why even bother giving these unsafe machines approval at all… maybe they can approve the electric chair as a medical device too…)

      Oh yeah, and after 20 plus years of inducing violence SSRIs are more popular than ever. How about some realistic warnings from the FDA or some official action against the prescribing of dangerous drugs to childbearing women?

  3. I have been hearing and reading and experiencing the shortage issue of Armour Thyroid. Today 10/12/09 I finally called Armour Thyroid and spoke with a Forest Pharmaceuticals rep. She said that the FDA has not stopped production and they have not received any noticification that that was the case. It’s a supplier issue affecting the production. Don’t know why the supplier is having an issue. She said they are currently working to get the product back out to the market place and had recently sent out an order of 1 grain. I called my local Walgreens (who had nothing a couple of months ago) and they now have 1, 1.5 and 2 grain available. I surely hope there is NO truth to the FDA stories. My body does not like the synthetic stuff!

  4. I went today (Oct 13, 2009) to refill my Armour Thyroid and was told by the pharmacist that it is no longer being made. He still had some on hand in other strengths and was able to give me a month’s supply.

    Over two years ago when I called Forest Pharmaceuticals and I was told that there was a ‘quality control’ issue with 180 mg (3 grains) and it would be available within 6 months. Since then I have heard a lot of buzz about the FDA wanting to pull the product from the market.

    I’ve had TD since I’m 7 years old but wasn’t diagnosed until my early teens I’ve been on meds since 1965. Synthroid was a nightmare.

    I’m calling Forest tomorrow and will be contacting my doctor and the FDA. I want answers! It seems that if the government has its way, we should “Go Green” but it’s ok to rely on synthetic medications. Does that make any sense?????

    1. Yes, not only is the synthetic part a problem but also the different types of thyroid that are missing.

      I am looking into natural ways to support thyroid function and have been advised to use B5, Tyrosine, and iodine to make my own Thyroid. Some people think that supplying the Thyroid with hormones helps the organ to atrophy worse, but it is obviously necessary in many cases. I do know many people who have eliminated some of their Thyroid problems when they did a detox to get rid of harmful chemicals collecting in their bodies like fluoride, etc. Also antidepressants suppress thyroid function.

      I have been taking NatureThroid for a couple of months now and it is working way better than the Armour was working for me ever since the reformulation. Apparently they added some cellulose to Armour which may interfere with absorbtion. Check out Mary Shomon’s blog, the Stop The Thyroid Madness blog, and Synthroid Haters.


  6. I have been taking Armour for years and when I needed a refil, Walgreens said that it was on back order. I had nothing to take except some old Thyroid from a couple of years ago and that dosage is not right for me now, but I took it anyway for 3 days. I had been doing some research on the computer and came up with Nature-Throid. Some people were able to get that and were doing well on it, so thought I would ask my doctor for a perscription for that. Well he refused to give me a perscription for that. He said it would harm me. I had quite an argument with him and finally excepted a perscription for Synthroid which I know I can’t take. I am still researching to see if I can get Nature-Throid from someone, otherwise I know how I am going to feel in the future if I keep taking the Synthroid that he wants me to take. What on earth is going on?

    1. I was taking NatureThroid and when we went to refill it a few days ago it was no longer available. So I ended up calling my doctor’s office and they called in something to a compounding pharmacy and it’s just regular old dessicated thyroid (all natural). Also there is an article on thyroid solutions in Natural Solutions Magazine (http://www.facebook.com/NaturalSolutionsMagazine) this month – they interviewed Mary Shomon. Check it out there are a lot of good suggestions for other things you can add on to help your body make thyroid hormone.

  7. All of the thyroid manufacturers have been pulled. I no longer have a thyroid and am forced to take the only pill on the market called Mylan and it has been a horrible experience. Made even worse by the thought that this inferior medication has now been given a monopoly of the entire US market.

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