Thyroid Patients: How To Survive the Shortage of Armour and Nature-Throid Natural Desiccated Thyroid Drugs
With announcements by both Armour Thyroid's manufacturer Forest Labs, and Nature-Throid/Westhroid manufacturer RLC Labs that these thyroid drugs are on nationwide backorder for at least three month, thyroid patients naturally have questions about what this means for their treatment.
A Look at the Shortage
First, let's take a look at the situation.
This past spring, Armour Thyroid, which has been plagued by ongoing shortages and back-orders for more than two years, underwent a reformulation of its filler ingredients. During the time of the reformulation, there were severe shortages of Armour at all dosage sizes. Some patients who had been prescribed Armour switched to the other brand name natural desiccated thyroid drugs made by RLC, Nature-Throid and Westhroid (which is identical to Nature-Throid).
After the Armour reformulation, some patients taking reformulated Armour complained that hypothyroidism symptoms were returning, or complained of other symptoms including heart palpitations. Many of the patients who did not respond well to the reformulated Armour switched to Nature-Throid.
Based on Armour Thyroid's continuing problems, RLC, therefore, had an unexpected influx of demand for their thyroid drugs, and that demand increased further as patients switched from the reformulated Armour Thyroid.
At the same time, American Laboratories, Inc., the sole supplier in the US of Thyroid USP -- the desiccated porcine thyroid powder that is the active raw ingredient in Armour, Nature-Throid and Westhroid -- has been unable to provide a steady, sufficient quantity of product to the drug manufacturers, which is worsening the production situation.
Where Can You Still Get Natural Thyroid Drugs?
Currently, supplies of Armour -- except for dwindling supplies of 4 and 5 grain size tablets here and there in the market -- are almost nonexistent. Very few pharmacies are reporting having any stock of Armour Thyroid, and those that do have only the reformulated Armour Thyroid.
There are some supplies of Nature-Throid and Westhroid (and keep in mind, these are identical products, identical ingredients) in the market, but they are located mainly at independent, small, local, and compounding pharmacies, especially those who have dispensed Nature-Throid and Westhroid for a long time. The Nature-Throid stock available at these pharmacies is likely to be depleted fairly soon, however. There are also some physicians around the country who keep stock of Nature-Throid on hand for their clients. How much these doctors have stockpiled is unknown.
You are less likely to get Nature-Throid or Armour from chain pharmacies, and national mail-order pharmacy benefits manager firms like Medco and Express Script have indicated that they are unable to fill any desiccated thyroid prescriptions for their customers.
How Long Is This Situation Going to Continue
It's likely to go on at least three months. Forest Labs has said that they cannot estimate when they will resume shipments of Armour Thyroid. RLC Labs has said that they expect to resume shipment within 90 days.
Some pharmacists have suggested to me given the Thyroid USP shortage, there is insufficient Thyroid USP available presently to -- over the next several months -- produce Armour Thyroid, Nature-Throid, Westhroid, AND to supply compounders who make compounded desiccated thyroid preparations. Meaning, that should all the manufactured natural thyroid pills be unavailable, the shortage of Thyroid USP will likely make it impossible for all patients who would want to switch to compounded medication to get prescriptions filled.
Bottom line: at some point in the next several months, some patients will likely face a complete unavailability of all desiccated thyroid drugs, manufactured and compounded.
Are you likely to be affected, and what can you do?
Which Patients Are Most Likely to Be Affected?
The patients most likely to be affected by the shortages include the following:
- Patients who are newly prescribed a natural desiccated thyroid drug, and whose physician does not maintain his/her own stock of Nature-Throid
- Patients who run out of their natural desiccated thyroid drugs and attempt to get a refill
- Patients whose pharmacies were not already regularly working with RLC
- Patients who use large chain pharmacies, or who get their prescriptions filled at Walmart, Costco, etc.
- Patients who get their medicines through large mail-order pharmacies, like Medco, or Express Scripts.
Advice from Nationally-Known Physicians
I asked some nationally-known doctors who work with thyroid patients, and who have been prescribing natural thyroid drugs for years, what they recommend for patients who may have to deal with the natural desiccated thyroid shortage over the next several months.
Jacob Teitelbaum, MD, author of "From Fatigued to Fantastic," and a nationally-known expert on chronic fatigue, fibromylagia, hypothyroidism, and hormone imbalances, had this to say:
Although the desiccated thyroid may get backordered , I suspect the synthetic T4 and T3 individually will still be available to compounders (or in the form of Synthroid and Cytomel). People can get the Synthroid and Cytomel and individually take the amounts needed to get the two individual hormones. On the downside, this does not supply the rest of the glandular components. On the upside, I suspect that some with Hashimoto's may actually have the immune reaction stimulated by the glandular tissue, and the pharmaceutical forms may be cheaper than the compounded.
My fear is that with people trying to figure out how many each of Synthroid and Cytomel to take, some will get it confused and get into trouble. I would consider Thyrolar, but this is also back-ordered.
Bottom line? When able, I would go with the compounded, having the doctors call in the strength in grains or amount to replace a given strength of desiccated thyroid. I have major concerns about which compounders I use for thyroid, as analysis of thyroid caps from different compounders has shown remarkable (scary) variability in potency. I would only use ones that have occasionally done assays on their product to assure consistent and reliable strengths. I use ITC Compounding Pharmacy for my thyroid patients, as they are compulsive about quality control. 888-349-5453 (303- 663-4224 outside the US).
This is the approach I'll be using for my patients.
David Brownstein, MD, is a physician in practice in West Bloomfield, MI and author of a number of books on thyroid disease, among them, "Iodine: Why You Need It, Why You Can't Live Without It," and "Overcoming Thyroid Disorders."
It is unbelievable that we have to put up with this. There should be an appropriate investigation to see what has happened and the appropriate companies need to explain how this can happen. People's lives are at stake.
Patients will have to be flexible. Don't give up hope. Be willing to try various combinations until you find the one that works best for you.
There are still options out there including T3, long acting T3, T4/T3 combos and T4.
I would say the first change should be a T4/T3 combination in a similar amount to the presently taken dessiccated amounts. Each grain of desiccated thyroid supplies 38 mcg of T4 and 9 mcg of T3. To make the conversion: 1/2 grain of desiccated thyroid would correlate to approximately .025 T4 and 5 mcg of T3. 1 grain: .05 mcg of T4 and 10 mcg of T3. For increasing doses increase the amounts of T4 and T3 correspondingly. If patients don't feel well, I would suggest going with compounded T3 in a longer acting form.
Also, Biotics Research has a glandular thyroid called GTA Forte*. It does not contain T4 but does contain T3 and all the other glandular constituents. They may also be a source for the time-being for those needing the glandulars.
Kent Holtorf, MD is a nationally-known hormonal medicine expert, and founder of the Holtorf Medical Group in California.
We have run into this shortage problem and some of our patients taking the reformulated Armour noticed a worsening of symptoms and reduced serum levels. When we've encountered shortages through the years, we have switched patients back and forth between Armour, Nature-Throid, Westhroid and compounded versions with little problem.
I would recommend that the patients ask their doctors to write the same dose to be compounded by a compounding pharmacy.
A little trick you can tell them is to ask their doctor to change the ratio from 38 mcg T4/9 mcg T3 to 38 mcg T4/10 mcg T3 (or 76/18 to 76/20), etc. It is a small change but a a good percentage of patients will feel a little better.
With any change of brand or version there will be some difference in absorption so watch for symptom changes. It is recommend that they be monitored with blood work about 3 to 6 weeks after the change to see if any there's any significant difference. But if there are no symptom changes -- or the patient feels especially good -- blood work can be put off.
Adrienne Clamp, MD is a physician in private practice in Silver Spring, MD, who regularly uses natural thyroid in her practice, and who takes it herself for her hypothyroidism.
My advice is, and has been, take a deep breath, there is always a way to solve this.
As in those with pork intolerance, you can prescribe either an compound or make up the combination dose of T4 and T3 from synthetics that the patient has been getting. For instance, say me, I take 180 mg of Armour a day (or did until changed to Nature-Throid after the newly formulated Armour shot my TSH way up). 180 mg of Armour is the equivalent of 114 mcg of T4 and 27 mcg of T3. In that case, I would likely choose to fudge on the side of T3 and give 112 of synthetic T4 once a day and 15 mcg of T3 twice a day. If the patient was especially sensitive, I might give the T3 as a sustained release compound. I would also maximize supplement status for optimal conversion of T4 to T3 (i.e, iron**, magnesium, selenium, zinc, folate and other B vitamins, vitamin D, and support adrenal function as necessary.)
We are all hoping that the situation will improve and supply available again soon, but "there is always more than one way to skin a cat" in my book.
Additional Information from Mary
Here are some additional points to keep in mind.
There is absolutely no difference between Westhroid and Nature-Throid whatsoever. If you find a pharmacy that has some stock of Westhroid, they can fill a Nature-Throid prescription, and it's the same product.
There may be some BioTech brand Bio-Throid, a prescription natural desiccated thyroid medication out in the market, as well as some generic desiccated thyroid still left on the market. Your best chance is to call your local independent pharmacies, especially those that do compounded or bioidentical hormones.
You may be able to get your prescription filled by a Canadian pharmacy. Canada has a generic natural desiccated thyroid drug, referred to as "Thyroid," which is made by ERFA Drugs.
Some of the foreign pharmacies that ship to the US may have some remaining stock of Nature-Throid, Westhroid, Armour Thyroid, or foreign brands of natural desiccated thyroid like Thyroid-S.
During the shortages, ask your doctor to write your prescription for desiccated thyroid as broadly as possible. For example, a prescription for "desiccated thyroid, 1 grain" can be filled with Armour, Nature-Throid, Biotech, or a generic. But if they write "Armour Thyroid, 60 mg" for example, you won't be able to get "Nature-Throid."
If you use a mail order pharmacy like Medco or Express Scripts, ask for your prescription to be returned to you, so you can attempt to get your natural thyroid medication filled elsewhere.
* Dr. Brownstein mentioned the glandular thyroid supplement GTA Forte from Biotics. Some other over-the-counter thyroid glandulars include Nutri-Meds Porcine Thyroid Glandular Concentrate Capsules and Tablets and RLC's Hypo Support Formula. These are non-prescription dietary desiccated thyroid products with the T4 removed, meaning they provide only T3. Dr. John Lowe has provided some guidelines for patients on how these glandulars are used, but it's generally recommended that you use these products only under physician's guidance.
** Be sure to take iron at least 3 or more hours apart from thyroid medication, to avoid problems interfering with your thyroid medication absorption.
About Mary Shomon | Thyroid Forum | Twitter | Facebook
Photos: istockphoto.com
Comments
Thank you so much for writing this, Mary. You are an angel. I am a new patient since July and I have been in a panic since last week when I tried to refill my prescription of Nature Throid. I have never heard of drug shortages before and neither has my family. They can’t believe I have to go through this! I can’t either! I don’t take any other medications and I have never heard of such a thing. Your support and information are life savers but if one is not medically knowledgable, this can be overwhelming. Why is this happening?
Thank you, Mary. I’ve been without Armour Thyroid now for 3 weeks, and I’m so frustrated. What a nightmare. As soon as my drugstore told me they couldn’t get it, I called my doc. Her assistant told me, “Just take synthroid.” (I have severe reactions to it) Then, “Just call around to different pharmacies.” (No one has it, and they wanted to know why I didn’t just stick with something “safe” like synthroid) Then, “The doctor thinks drugstore.com has it in stock.” (Nope) I have seriously thought of switching endocrinologists, even though this is the first one who was willing to try something other than synthroid. Not sure what to do next, but your information will help me be more informed at my next appointment in just a few day. Lots of luck to everyone else out there in the same boat.
Mary, Thanks for all your efforts to keep us informed and for sharing the physicians’ advice.
I suspect that many of us will be forced to go on T4 synthetics completely. I fought tooth and nail to get on armour and I’m not looking forward to putting up another fight. I suspect my current doc will not want to deal with this because this is completely outside her interest and capabilities. She will advise me to see an endo and after seeing 5 of them previously, there is no way I’m going to subject myself to another condescending and invalidating experience. It truly amazes me that 11 years later, I’m going through this again and there has been no advances in the way endocrinologists treat hypothyroidism. If USP Thyroid was generally accepted by endocrinologists, I can’t imagine we would be having this shortage.
Just diagnosed a few months ago and worked to get the natural according to your recommendation. Is is safe to switch to T4 synthetics for a few months? And then back again?
We still need to find out WHY. Why the sudden change in Armour. What is really going on. Do we need to get a group of people and investors together and go to Canada and start our own pharm company.
Thank you for keeping up on this saga, Mary. It is hard not to be angry and scared. It took me many years of experimentation before I got to feeling relatively well, and that came with the gradual shift away from synthetic to almost 100% Armour.
Now with all this, I am terrified of what I’m going back to. I can’t believe they can tell me with a straight face to “just go back on the synthetic, you should be fine”. I wasn’t fine when I was on it before!
I’m ready to start raising pigs in my backyard and (quoting an old regular) brewing my own in the bathtub (sigh).
Dang~~ well now know why my pharmacy has had to (many times) give me four – 30mg instead of a 120.Thanks so much for this. I’m going to print and send to my Doctor. I only a few months ago found out not to use soy in any form. Shoot, I have a soy milk maker, and not only made soy milk, but also Tofu, and I used the akara in many dishes. I’m the one who informed my doctor. Now I’m just finding out not to take my Armour thyroid, at the same time as iron. Being anemic at times I was taking iron to keep my Doctor happy, but feel that the best cure for that is Liquid Chlorophyll. When did Armour reformulate? Just what does it mean? I’ve been on Armour Thyroid for several years.
Dear Mary,
First. Thank you. I was diagnosed 12 years ago with Hashimoto’s, felt horrible on Synthroid and found my education here. Now, I come to you again to find out why Armour isn’t available, only to find out too late about the reformulation (hmm, and I was kicking myself a few months ago wondering if I was too stressed or what possibly could be wrong with my hormones that sent my TSH sky high??). Sadly, I loved Armour for the 10 years I was on it and felt great, but if Forest keeps the new formulation, I will have to find another brand.
I do not understand why there should be any issue at all with the reformulated Armour. All they have done is change the amount of dextrose/cellulose in the tablet….not the amount of hormone. I am sure of this as I spoke directly with the Laboratory Scientist at Forest who is in charge of this. Niether of these should impact in any way the glandulars or other hormones in this pill. Is the reformulation causing a change in where, along the GI tract, the drug is available for uptake? If that is the case, how are these 2 sugars causing this to happen? And, where is this happening? Is it possible that thyroid drug uptake is more sensitive or more localized than currently understood?
The FDA should demand proof of consistent dosage!!!!! And, reports of changes in patients responses to the new reformulation should spark the need for proof!!!!!
HOwever, If the FDA is trying to pull this drug because of speculation then they need to be sued!!!!
I am aware there has been talk for some time about retro virus and other virus in all of the swine population in the USA. Does anyone know what the literature is saying about this currently? Even Gerson Institute has a disclaimer about viral infectants being possible???
I keep telling people they need to get at least a year ahead at all times of life saving medication!!!
I don’t use my insurance for this drug. It is fairly cheap.
My doctor gives me that ability by writing up prescriptions for what ever I need for a whole year and then I just rotate this stuff out on my own.
I am chairperson of EPAC, a 560,000 family disaster Preparedness group.
Do you really think thyroid medication will be available if we have a widespread long recovery event???????? Not likely!!!
I hate not having a thyroid gland….mine was removed in error.
Now I have to depend on a system I dont trust.
I just wrote to the Washington, the FDA, and all of my state reps in Vermont. The FDA has a job to protect all patients. We should not be put into the position of drug seeking for a prescription that is necessary for us to function. What has the FDA done to protect thyroid patients that cannot tolerate synthetic hormone? I basicly asked them that question because they are supposed to have all the answers. I also sent copies of my letter to the major news networks. One never knows who is a thyroid patient that will take interest in helping patients get well. I encourage everyone to write a letter and copy/paste it to everyone that you can think of!
I believe this is just a conspiracy instigated by the large pharmaceutical companies to get the natural thyroid hormones off the market. Is it possible that American Laboratories, Inc., the sole supplier of Thyroid USP, is in the pockets of the pharmaceutical companies that produce synthetic thyroid replacement drugs?
I agree with Jeanette in post #11. I’m not one for conspiracy theories…but when one combines all the different ‘forces’ working against natural thyroid being available to patients, i.e. Armour’s reformulation issue/ineffective reformulation, chronic supply issues accross brands and now Mary’s info about the FDA’s efforts to paint natural thyroid as no longer grandfathered in, plus current healthcare legislation on the table coupled with huge economic issues for companies….it all seems HIGHLY suspicious to me. Again, I don’t like to jump to assuming agendas but the red flags are all there. BTW, I’d been on Armour a yr for Hypothyroidism, sufferred heart attack symptoms that led to thousands of dollars worth of heart tests (!!) after Armour’s reformulation (WITHOUT my having read anything about the reformulation or other people having issues) and switched to Nature Thyroid and within 3 weeks feel much better again. Someone mentioned the change in fillers shouldn’t cause such a huge issue for people. I agree. BUT, how do we KNOW that Forest didn’t actually have a major manufacturing process issue and that the therapeutic level in the drug didn’t actually shift – or a shift in the raw materials! It’s all deplorable in my books. I SO SO appreciate Mary, her efforts on our behalf and the information she shares. We’re blessed by her dedication and help. THANK YOU MARY! Kuddos!
RE: Natural thyroid
My pharmacist said that slaughterhouses are changing the way that they handle animal organs. They used to have someone remove the organs that were used for medicinal purposes, but now most of the packing houses just throw all of the organs into a large box with all the other “innards” which will then later be made into animal food, etc.
He also said the “$4 prescriptions” are an attempt by name brand drug manufacturer’s to put all generic drug manufacturer’s out of business so that they can then jack the prices up sky-high on these same prescriptions when they are the only ones left in business.
Reminds me of “Business 101″ where I learned that Standard Oil did this in order to crush its competition many years ago.
ARGH! After 9 long yrs. on generic levothyroxine and Cytomel I was just going to switch to Armour NEXT WEEK! The reason I’m switching is because I’ve continued to have hair loss even after my TSH has been well-managed by the drugs. I’ve had female hormones checked, male hormones by the dermatologist … everything checked out okay! The only thing that remained was the 9 yrs. of synthetic thyroid hormones. I never knew that hair loss was a side effect of the meds – sheesh! Now what to do???
This is insane. Its like telling diabetics they cant use insulin. I am completely allergic to all synthetic forms of thyroid and Nature-Throid was the only product that agreed with me. Without it I will go into a coma and my heart would drop to the point where I would barely be alive.
This is not right! These companies cannot play around with peoples lives like this. There needs to be some investigation of this issue and it needs to be resolved so that none of us are faced with this challenge ever again!
I’m in the same boat as Barb (above). The endo who confirmed my self diagnosis 6 years ago prescribed for me the only thyroid drug she ever does, Synthroid. When the smallest therapeutic dose caused me to become clinically and symptomatically hyper, she actually told me to stop taking it and to just remain sick until I could “tolerate” the Synthroid. Who in their right mind would do such a thing without even trying another type or brand of thyroid replacement? I immediately found an Armour prescriber and did marvelously well with that product until Forest recently screwed it up. And now that I’ve found a completely suitable replacement in Nature-throid, the Feds are attempting to take that away from me, too?
Where the hell were the safety-conscious Feds when people were dropping dead from Baycol, Vioxx, Zyprexa, Rezulin, Phen-fen, and the ever expanding array of dangerous and defective Big Pharma chemical soups?!?! Oooohh, that’s right… sitting on their back pockets so plushly lined with kickbacks and hush money for giving their full approval to all that poison.
This is EXACTLY the same thing as disallowing a diabetic to have insulin. No difference at all.
Thank you for assembling advice from trusted thyroid MDs, but this leaves me with several questions.
Kent Holtorf, MD states “When we’ve encountered shortages through the years, we have switched patients back and forth between Armour, Nature-Throid, Westhroid and compounded versions with little problem. A little trick you can tell them is to ask their doctor to change the ratio from 38 mcg T4/9 mcg T3 to 38 mcg T4/10 mcg T3 (or 76/18 to 76/20), etc. It is a small change but a a good percentage of patients will feel a little better.”
Q1 – If a good percentage of patients feel better with increased T3 in the established T4/T3 4:1 ratio, and this MD has switched patients back and forth over the years, then is it possible that most patients currently taking natural dessicated thyroid products can safely switch to compounded synthetic T4/T3? I’d like to see some scientific study on this question, as I’ve often wondered about the need for the other glandular components of natural dessicated thyroid.
David Brownstein, MD states “Each grain of desiccated thyroid supplies 38 mcg of T4 and 9 mcg of T3. To make the conversion: 1/2 grain of desiccated thyroid would correlate to approximately .025 T4 and 5 mcg of T3. 1 grain: .05 mcg of T4 and 10 mcg of T3.”
Note – These conversion factors are not mathematically correct, as “.025 T4″ should say “25 mcg T4″, and “0.05 mcg of T4″ should say “50 mcg of T4″ for approximate dosage conversion to standardized tablet dosages.
Q2 – Suggested conversion to 50/10mcg T4/T3 increases the amount of T4 in the T4/T3 ratio from 4/1 to 5/1. Is it wise to increase T4 when T3 is the most bioavailable form without need for bioconversion of T4 to T3?
Q3 – If one doesn’t have access to a compounding pharmacy, and must use synthetic levothyroxine/Cytomel tablets, will this usually be an acceptable substitute for compounded tablets? Levothyroxine is available in the following mcg tablets: 25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200, 300 and Cytomel and generic Liothyronine in the following mcg tablets: 5, 25, 50. So for each 1 grain of Armour or other dessicated, is it best for most people to take 50/10mcg or 5/1 ratio of synthetic T4/T3? The nearest compounding pharmacy is too far from my house, and I fear that it might be more expensive as I pay out of pocket. I’d like to know what works for most people when taking standard synthetic T4 and T3 tablets so that I can advise my physician. I only have a one month supply of Armour and my local pharmacies are out of stock of Armour and RLC products. I’ve suffered extremely painful fibromyalgia while taking levothyroxine for over 10 years before discovering the merits and pain relief of Armour a year ago, but I’m willing to try the mix of T4/T3 synthetics if that works for most people.
Jacob Teitelbaum, MD says “People can get the Synthroid and Cytomel and individually take the amounts needed to get the two individual hormones. On the downside, this does not supply the rest of the glandular components. On the upside, I suspect that some with Hashimoto’s may actually have the immune reaction stimulated by the glandular tissue, and the pharmaceutical forms may be cheaper than the compounded. I have major concerns about which compounders I use for thyroid, as analysis of thyroid caps from different compounders has shown remarkable (scary) variability in potency”
Q4 – I have Hashimoto’s with skyhigh antibody levels, and also almost never get the flu with my immunity on overdrive. The only time I’ve had the flu in the last 5 years is a 2-week period immediately after I switched to Armour. Mosquito bites usually result in a 2-3 inch painful inflammation which requires several days of ice for relief. I’ve had this mosquito bite immune reaction problem for years, but it’s gotten worse since being on Armour. I thought that Armour generally reduces the immune reaction, and that anti-thyroid and thyroid-peroxidase antibodies typically decrease after Armour is started. Now I’m wondering whether the Armour’s glandular components are increasing my immune reaction as evidenced by the increased swollen mosquito bites and no flu. As this MD notes that compounded tablets have significant variability in potency, might I be better off using synthetic T4 and T3 tablets? Also, what percent of Hashimoto’s patients have an immune reaction to glandular tissue?
This situation is frightening for me.. I can not and will not, go back on the synthetics again.. I will not live that way… I can’t believe this situation.. I don’t understand why something had to be “fixed” that wasn’t broken.