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Has the FDA Not Approved Armour Thyroid?

A reader was surprised to learn that FDA has not approved Armour thyroid or other desiccated thyroid extracts. However, some people feel better taking it.
Armour brand desiccated thyroid extract

Levothyroxine, a synthetic version of the thyroid hormone known as T4, is at or near the top of the list of most prescribed medications. Millions of Americans need to take this medication because their own thyroid glands don’t produce enough. While the majority of people on levothyroxine do pretty well on it, some people find they still have symptoms of an underactive thyroid. Among them, a number have reported that they feel better on desiccated thyroid gland such as Armour. It comes as a shock, though, to learn the FDA has not approved these old-fashioned medications.

Trying Out Armour for Hypothyroidism:

Q. My doctor is cool with anything reasonable that I want to try. So when I asked for a scrip for Armour Thyroid instead of the levothyroxine (Levoxyl) I’ve been taking for years, he agreed. I have been on Levoxyl ever since my thyroid was removed to treat Graves’ disease.

I’m on Medicare and my insurance denied it because it is not FDA approved. It’s inexpensive, so I paid cash for it, just $20.

My poor daughter, who has hypothyroidism due to Hashimoto’s, asked her endocrinologist and the reaction was swift. “NO! I don’t prescribe Armour to anyone I care about. Tell your mother not to take it.”

I’m taking it anyway, and in another six weeks I’ll be getting labs done. If it’s working, great. If not, I return to Levoxyl. I haven’t noticed any difference, but I’ll go with the bloodwork.

Are you aware the FDA has not approved this? Apparently, it’s some kind of control over how much of each hormone (T3 and T4) the pill contains.

Why the FDA Has Not Approved Desiccated Thyroid Extract:

A. Armour Thyroid and other brands of desiccated (dried) thyroid extract (DTE) are made from pig thyroid glands. Before there was synthetic thyroid (Synthroid or levothyroxine), doctors relied upon DTE to treat people with underactive or missing thyroid glands. These products were grandfathered into pharmacy practice.

According to the official prescribing information for Armour Thyroid,

“This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.”

However, the description of the drug specifies exactly how much T3 (liothyronine) and T4 (levothyroxine) each grain of thyroid extract contains. We suspect that the reason FDA has not approved these drugs may be linked to the cost of applying for New Drug Approval. Quality control in the mid-20th century was lax, and the drug got a bad reputation among endocrinologists for that reason. We understand that has improved, but some experts are still leery of prescribing it. Nonetheless, endocrinologists should be personalizing thyroid treatment (Frontiers in Endocrinology, July 9, 2019).

Learn More:

Most people do well on medications such as Levoxyl or Synthroid with levothyroxine alone. Some, however, report that they feel much better on Armour or another desiccated thyroid extract, presumably because it contains T3 as well as T4. You can learn more about this and why it’s important in our eGuide to Thyroid Hormones.  You may also wish to listen to our interview with Dr. David Cooper, Director of the Thyroid Clinic at Johns Hopkins. It is Show 1162: How to Treat Common Thyroid Problems. In it, we discuss Graves’ disease and hyperthyroidism as well as Hashimoto’s and hypothyroidism. We also discussed how genetic variations might explain who feels better on desiccated thyroid extract in Show 1096: What You Need to Know About Treating Thyroid Disease.

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About the Author
Terry Graedon, PhD, is a medical anthropologist and co-host of The People’s Pharmacy radio show, co-author of The People’s Pharmacy syndicated newspaper columns and numerous books, and co-founder of The People’s Pharmacy website. Terry taught in the Duke University School of Nursing and was an adjunct assistant professor in the Department of Anthropology. She is a Fellow of the Society of Applied Anthropology. Terry is one of the country's leading authorities on the science behind folk remedies. .
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Citations
  • McAninch EA & Bianco AC, "The swinging pendulum in treatment for hypothyroidism: From (and toward?) combination therapy." Frontiers in Endocrinology, July 9, 2019. DOI: 10.3389/fendo.2019.00446
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When I was diagnosed as hypothyroid in 2003 my physician advised that he would not treat me if I used synthroid due to morbidity numbers. I agreed. In 2 weeks on Armour my TSH dropped from 57 to 4, and my clinical depression of 10 years disappeared. No debate about effectiveness is possible with me. I have fought physicians and insurance companies successfully because I refuse to switch from Armour.

When I took the generic Synthroid, I gained 50 Lbs. I went to an integrative doctor, and she put me on Armour. The 50 Lbs. came off without changing my eating habits. It seems that I could not convert T4 to T3. T4 is said to be a storage hormone. Natural dessicated thyroid contains T4, T3, T2, T1 and calcitonin which are all the hormones in a healthy thyroid. Unfortunately, the NDTs have changed for the worse, in recent years, according to Stop The Thyroid Madness. The one that was favored, in recent years, was NP Thyroid but, they changed their manufacturing and now smells like fish or worse. So, it has been advised to return to levothyroxine and add T3 for those of us who cannot convert. This has been advised by Janie Bowthorpe who manages the Stop The Thyroid Madness website and has written three books on the subject. I feel better when my TSH is low. Also, I like to know what my entire thyroid profile looks like so I don’t just get the gold standard, doctor worshiped TSH test.

I have been on Armour Thyroid for over 40 years and have never had to change the dose. My blood work every six months is perfect.

I take 130 mg of Armour. Because I’m on Medicare, and it’s not covered, I have to pay $150 for a 3-month supply. Nature Throid is cheaper but unavailable for months on backorder.

I sure know it made a BIG difference for me!!! My doctor did a bit of an eyeroll when I first told him that is what I took but he wrote the rx, and that’s all I care about!

My endocrinologist refused to prescribe Armour Thyroid or Nature Throid so I went to a Naturopath and have been on desiccated thyroid extract ever since. I feel so much better!

My late wife, a Type 1 diabetic (40+ years), was on the synthetic or the Armour at one time or other. She frequently said she felt better when she was on the Armour.

I’m one that Synthroid did nothing for and feel “much” better on Armour. Labs are good

Synthroid never worked for me. I was put back on Armor Thyroid 18 months ago because of my own request and I had to be firm with the doctor about it and my blood work has been very good. I was surprised that it is not FDA approved. Some of us need that little extra from it.

Sorry, FDA, Synthroid and other synthetics just don’t work for me. My body can’t use them, and my tests show I’m deficient when I’m on the synthetics. The endocrinologist I saw at a university medical clinic refused to prescribe DTH and never acknowledged that synthetics might not work. Everyone is different. There are many drugs it’s not safe for me to take.

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