Tag Archives: Armour thyroid

Margie Reports Her Success with Armour Thyroid


Hello, Everyone

I was diagnosed Hypothyroid 10 years ago, I have two sisters and several aunts with the same problem. I was prescribed synthroid and it was a Godsend for the first three years even though I was up and down, however I began to be more and more tired and just generally did not feel good, my dosage was up and down, finally doctor prescribed cytomel to go with it. still no good my bones hurt all the time especially my hip going down my leg and in the middle of my upper back, my beautiful teeth damaged. I finally told my Doctor to either give me the Armour or I was going to find another Doctor who would, He did and shazamm all symptoms disappeared, I feel great Like before I ever had this problem, I Thank God for Armour, and I also avoid flouride, chlorine

Endocrinologists Take a Backward Step in the Treatment of Hyperthyroidism


When I became an endocrinologist in 1981 I was truly excited about the field. At that time it seemed that the science of endocrinology was expanding rapidly and new discoveries were on the horizon particularly in regards to the way hormones effect the brain, mood and the immune system. Was I ever wrong! It’s thirty years later and none of those expectations were realized. In fact, I find that the field of endocrinology has barely budged since then and in some areas has actually lost ground.

Bringing on this round of pessimism on my part, is a recent “development” in the area of treatment for hyperthyroidism (over active thyroid). Ever since I was in training there have been two medicines, propylthiouracil (PTU) and methimazole (Tapazole), which are the mainstays of medical treatment for hyperthyroidism. Both medicines have been available since the 1940’s and show excellent efficacy and tolerability (and they are cheap!). Almost all endocrinologists I have met use these two drugs interchangeably although in pregnancy propylthyiouracil is favored due to rare birth defects in fetuses exposed to methimazole.

The “development” which I find so discouraging is the recent action by the FDA to place a very strict (black box) warning on the use of PTU due to the possible occurrence of a rare form of liver injury attributed to the drug. After almost 70 years of exemplary use, this has given rise to extensive debate in the endocrinology literature about how to restrict PTU use.

While it is true that methimazole is equally as effective as PTU to treat hyperthyroidism, I have personally seen numerous cases of fairly severe allergic reactions to methimazole. Fortunately it has been easy to continue medical treatment by simply switching to PTU. If we can’t use PTU freely then the only other options are surgical removal of the thyroid or eradication of the thyroid using radioactive iodine, neither of which is free of potentially adverse outcomes.

I have never encountered severe liver injury with PTU nor has any of the colleagues I have polled. It has to be very, very rare. This is obvious because it has taken 70 years to get around to recognizing it formally. Can we really call it progress that we now have one less simple option for treating hyperthyroidism, a common and relatively benign disease? Let me take my cynicism to the next level. I won’t be surprised if a major pharmaceutical company soon announces the development of a new drug for treating hyperthyroidism. If I’m right the new drug will add nothing of real value that wasn’t previously available but is many times more expensive then the drug it replaces.

So goes endocrinology into the new century, the stogy old lady of medicine.

LA Falls Through a Crack in Our Health Care System and Finds Armour Shortage Crisis


LA lives in rural America and has no health insurance. After 30 years of effective therapy with Armour Thyroid she is unable to obtain this medication any longer. Her story is a sad reminder of just how far we need to go to provide meaningful health care to the citizens of this country.

LA tells her story like it is:

I knew nothing about this problem of non-availability of Armour Thyroid. I have been on Armour since 1978 and it has worked just fine. I had my annual prescription renewal in June and because I do not have insurance, I was able to get 200 pills at a time for a price break. I take 3 60 mg tablets a day and have been on this dosage for about 6 years, up from a previous dosage of 2 60 mg tablets. Today, 4 Nov 09, I went to pick up a refill that I called in a week ago. I was informed at the pharmacy that Armour Thyroid is no longer being made. Period. I took my last pills on 2 November so I have no medication at all. I have a call in to my doctor but he has not yet returned that call. We contemplated a switch to Synthroid a couple of years ago (for a variety of reasons, none of which are relevant here) but the doctor said it could be a very slow process of finding out exactly what dosage of synthetic hormone would adequately replace the natural Armour. At that time I had insurance that would have covered the lab tests required to determine the proper dosage. I am now without insurance due to the death of my spouse, and because of the hypothyroidism I am unable to obtain health insurance that is even remotely affordable. Therefore I can’t afford all the tests, all the doctor visits, all the rest of the hoopla that woudl go with switching medication. I’ve been fortunate so far that I’ve been able to keep my same doctor, and that he gives me a bit of a break paying cash for my once-a-year-visit, but he’s 60 miles away and I can’t even afford the trips back and forth if I have to start “nudging” a new medication. It’s bad enough to be without the medication for a while, but to think that it will never be available again? I honestly don’t know what to do.

I knew nothing about this problem of non-availability of Armour Thyroid. I have been on Armour since 1978 and it has worked just fine. I had my annual prescription renewal in June and because I do not have insurance, I was able to get 200 pills at a time for a price break. I take 3 60 mg tablets a day and have been on this dosage for about 6 years, up from a previous dosage of 2 60 mg tablets. Today, 4 Nov 09, I went to pick up a refill that I called in a week ago. I was informed at the pharmacy that Armour Thyroid is no longer being made. Period. I took my last pills on 2 November so I have no medication at all. I have a call in to my doctor but he has not yet returned that call. We contemplated a switch to Synthroid a couple of years ago (for a variety of reasons, none of which are relevant here) but the doctor said it could be a very slow process of finding out exactly what dosage of synthetic hormone would adequately replace the natural Armour. At that time I had insurance that would have covered the lab tests required to determine the proper dosage. I am now without insurance due to the death of my spouse, and because of the hypothyroidism I am unable to obtain health insurance that is even remotely affordable. Therefore I can’t afford all the tests, all the doctor visits, all the rest of the hoopla that woudl go with switching medication. I’ve been fortunate so far that I’ve been able to keep my same doctor, and that he gives me a bit of a break paying cash for my once-a-year-visit, but he’s 60 miles away and I can’t even afford the trips back and forth if I have to start “nudging” a new medication. It’s bad enough to be without the medication for a while, but to think that it will never be available again? I honestly don’t know what to do.
LAWHilton@yahoo.com
LA
1

Sandra Keeps Us Posted on Armour Reformulation


Sandra posts vital information for those who want to do something about the reformulated Armour Thyroid product, while she brings us up to date on related issues. Thanks Sandra!

Sandra writes:

I too have had a wonderful experience with Armour thyroid after years of struggling with synthroid and have been symptom free of my Hashimoto’s for the last three years – until now. Lethargy, muscle aches, hair loss, temperature disregulation, digestion problems, and just feeling like a 60 watt bulb only able to muster up 15 watts of energy. After reading what everyone has said I called Forest Labs and spoke with a pharmacist, a nurse and customer care. They were very interested in what I had to say and would like anyone who is having problems since the reformulation to contact them. The reason for the change is a supposed bioavailability increase with the change between sucrose (why the original tasted sweet) to cellulose. Doesn’t make sense to me as cellulose in indigestible and if the active ingredient is binding to it, it may be less available than with the sucrose formulation. Any thoughts? I also asked about the rumored FDA requirements – NO the FDA is not requiring them to go through trials as they are grandfathered in under the “generally recognized as safe” ruling. They have also just released a large amount of the one grain size (60mg) to pharmacies so it should be available. He said that if the pharmacy didn’t have it yet to call Forest Labs again. He also wanted me to speak to a nurse to document the symptoms I was experiencing. The transfer was quick – no getting put on long holds, and she was very thorough and pleasant. The pharmacist, Pat, and the nurse that I spoke to want to hear from the people who are having difficulties with the change in formulation – so Call, Call and Call again. The only way to get the formula back to where it was is if we let them know it now doesn’t work. Call 800 678 1605 ext 66297 for medical input and 66298 for customer service and quality control. One voice is a whisper, many voices is a shout to be acknowledged.

I too have had a wonderful experience with Armour thyroid after years of struggling with synthroid and have been symptom free of my Hashimoto’s for the last three years – until now. Lethargy, muscle aches, hair loss, temperature disregulation, digestion problems, and just feeling like a 60 watt bulb only able to muster up 15 watts of energy. After reading what everyone has said I called Forest Labs and spoke with a pharmacist, a nurse and customer care. They were very interested in what I had to say and would like anyone who is having problems since the reformulation to contact them. The reason for the change is a supposed bioavailability increase with the change between sucrose (why the original tasted sweet) to cellulose. Doesn’t make sense to me as cellulose in indigestible and if the active ingredient is binding to it, it may be less available than with the sucrose formulation. Any thoughts? I also asked about the rumored FDA requirements – NO the FDA is not requiring them to go through trials as they are grandfathered in under the “generally recognized as safe” ruling. They have also just released a large amount of the one grain size (60mg) to pharmacies so it should be available. He said that if the pharmacy didn’t have it yet to call Forest Labs again. He also wanted me to speak to a nurse to document the symptoms I was experiencing. The transfer was quick – no getting put on long holds, and she was very thorough and pleasant. The pharmacist, Pat, and the nurse that I spoke to want to hear from the people who are having difficulties with the change in formulation – so Call, Call and Call again. The only way to get the formula back to where it was is if we let them know it now doesn’t work. Call 800 678 1605 ext 66297 for medical input and 66298 for customer service and quality control. One voice is a whisper, many voices is a shout to be acknowledged.
sandra52525@gmail.com
Sandra
1

Obama Not to Blame for Armour Shortage, Says New Member


Will S., a new member of metabolism.com, offers these sensible comments on who to blame for the sad state of FDA oversight of prescription drugs like Armour Thyroid.

Will argues:

Gatekeeper: Just a suggestion to do a little more research on this situation before blaming it on Obama. It was several years ago, at the end of the Clinton and beginning of the Bush administration, that the FDA began to investigate and reveal that Armour Thyroid had never been officially approved by the regulatory agency. Membership on the FDA consists partially of highly paid executives that came from pharmaceutical companies. It makes sense that they have an interest in making sure that only the big pharmaceutical companies have the money to get their drugs approved. Situations like this are why we need health care reform now. Yes, you certainly can and should bring this issue to the attention of the current administration, but please place blame where it is due, as finger pointing in the wrong direction is unhelpful to those who are suffering.

Tina Sends the NY Times a Heads Up Regarding the Armour Crisis


Tina has raised her pen (actually her keyboard) to bring greater visibility to the Armour Thyroid crisis. Tina addressed her comments to one of the editors at the NY Times who actually appears to have taken this seriously and passed the email on upward. Thank you Tina, from me and those who are struggling with this unwarranted interruption in their medical treatment.

Here is the email sent by Tina to the NY Times Editor

Dear Ms. Kolata: I am writing in regard to recent restrictions on the availability of alternative, though highly effective, medications for hypothyroidism. Dessicated thyroid generics (made from the thyroid glands of pigs), known as Armour or NatureThroid, help thousands of people who suffer from low-functioning thyroids. I was on Synthroid, a synthetic thyroid medication, for years, but still suffered from symptoms. It was only when I began using NatureThroid, which treats all four of the hormone levels affected by the thyroid (vs. Synthoid, which only treats one), that my symptoms cleared up. I can’t tell you what a relief it is to no longer feel agitated and inexplicably moody, nor to have my hair falling out, my skin dry, etc. But it is becoming harder and harder to find dessicated thyroid generics. Armour, which has been around for about 50 years, is virtually out of business. Apparently the shortage has to do with FDA documentation requirements (which is odd; why now?)!
. Meanwhile, the American Academy of Clinical Endocrinologists (AACE) is backing Synthroid, which makes big money for its manufacturers (i.e., Abbott Laboratories). I hope this captures your interest. I don’t know what I, or thousands of others who have found relief with dessicated thyroid generics, will do if they are no longer available. If you would like more information, it may be helpful to go to https://www.metabolism.com. Thank you very much for your attention, Tina Montalvo West Palm Beach, FL

ARTICLE REFERENCED (if any):
None

Behind the Disappearance of Armour Thyroid


After 50 years of exemplary therapeutic use and despite a large devoted following, Armour Thyroid and related dessicated thyroid generics have virtually disappeared from pharmacies in the U.S. An air of mystery with suggestions of conspiracy surround the shortage. The level of distress among Armour users confronted by their inability to obtain the medication, is extraordinary. Adding to the turmoil and confusion is the manufacturers’ continued reliance on flimsy and unconvincing explanations for their actions.

Several concerned individuals contacted the FDA for clarification of the Armour situation and received a prepared statement in response. A copy of the FDA’s letter explaining the government’s stance was posted to metabolism.com by an involved member. After studying the letter I believe I can offer a good explanation for the situation. The explanation, as I see it, is grounded in the fact that several thyroid medications such as Armour Thyroid but also including synthetic t4 medications like Synthroid, existed before the FDA was given full regulatory power. In 1973 the Supreme Court empowered the FDA to regulate the use of prescription medications in the U.S.. This meant that all prescription drugs would have to demonstrate to the FDA’s satisfaction, safety and efficacy for specific indications before pharmaceutical companies could promote the use of their drugs. Medications like Synthroid and Armour, already vital components of medical therapy for years before 1973 entered a grey area of legitimacy after that time.

Just a few years ago, I was astounded to hear from my pharmaceutical representatives that Synthroid faced being banned by the FDA since it never provided the FDA with the type of documentation of safety and efficacy that all modern medications had. After 30 years the FDA decided it wanted to rescind the right of the drug manufacturer to promote this medication which was considered safe and effective way before the FDA achieved regulatory power. What followed was a tense year during which the manufacturer of Synthroid went through the costly and bureaucratically intricate process needed for FDA approval, which it ultimately won.

What I believe is happening now is a similar scenario with Armour Thyroid and other dessicated thyroid products. What convinced me of this is the wording in the FDA letter which refers to Armour Thyroid as an illegal drug. The FDA has put Armour on its Most Wanted List and is intimidating the manufacturer (and prescribing physicians) by implying the law is being broken by continuing to make and use this drug. In the case of Synthroid, which enjoys the full support by the medical community and provides millions of dollars in annual sales the financial equation was a “no-brainer” in favor of putting the money into the process to gain approval.

Not so for Armour Thyroid which has been defamed by the American Academy of Clinical Endocrinologists (AACE) and who’s use is much more limited and far less profitable to the manufacturer. I can imagine that the pharmaceutical company has already done the math and decided that not making Armour makes more financial sense that to continue making the “illegal” product and going through the FDA gauntlet for approval.

Where does that leave the patients who depend on dessicated thyroid preparations and the physicians who prescribe it? With no way to force the manufacturer to make the drug or to make the FDA to back down on its stance my guess is that Armour and related products will simply cease to exist and alternative prescriptions will have to be written. Please remember, I am the messenger here and do not sanction or in anyway condone what I see as the most likely outcome of this predicament. Perhaps by recognizing the existing reality a strategy can be developed to prevent this outcome.

Gary Pepper, M.D., Editor-in-Chief. Metabolism.com