Numerous and ongoing comments to my blog posts below about the newly formulated Armour are shocking and despairing.
Additionally, thyroid patients are crying out about the loss of being able to do Armour sublingually. (Was Forest Labs not paying one hoot of attention to thyroid patients the last few years in their praise of Armour because of it’s sublingual effectiveness??) Sublingual administration was a godsend for thyroid patients who had digestive issues, including gluten intolerance and Celiac, as well as those who needed to take iron tablets (which you can’t do at the same time as you swallow desiccated thyroid, but could do with taking Armour subingually)
So how in the world did Forest Labs get away with reformulating and producing a product that so many patients are reporting to be problematic?
It’s not FDA approved. As many of you may know, Armour desiccated thyroid, even when it was produced by a pharmaceutical other than Forest Labs, was around far before the FDA (Federal Drug Administration) came into being in 1938. That’s why it does not have the designation of “FDA approved” as do those drugs which were created after the FDA existed. It’s called an unapproved drug, but Armour was presumed to be safe and effective already.
From the FDA: Under the 1938 grandfather clause (see 21 U.S.C. 321℗(1)), a drug product that was on the market prior to passage of the 1938 Act and which contained in its labeling the same representations concerning the conditions of use as it did prior to passage of that Act was not considered a new drug and therefore was exempt from the requirement of having an approved new drug application.
Because it’s not “FDA-approved”, it does not have an NDA, aka New Drug Application. An NDA is used by the FDA to establish if the pharmaceutical product is safe, EFFECTIVE, more beneficial than side effects, and has in-house “controls” which maintain the quality, strength and purity of the product. (Thanks to “Ben” the pharmacist for reminding me of this.)
So…without that NDA, Forest Labs is, and has been, on their own, including with the latest introduction of a newly formulated Armour. So you might say, WE as patients were the guinea pigs. And sadly, we’ve been squealing and it’s a muddy picture.
The most important fact to state: USP (United States Pharmacopeia) desiccated thyroid is an effective and important drug which is changing the lives of a huge and growing body of individuals around the world. That was evident before Armour was reformulated, and is still evident with products like Naturethroid or Westhroid, which many patients are switching to. See my blog post about Naturethroid here, plus RLC Labs comment about Naturethroid here.
But something has gone terribly wrong with the reformulation of Armour, and patients appear to be leaving it behind in the dust in favor of another great and effective brand like Naturethroid. And whether it’s the fillers are not, Forest needs to take a new look at their reformulation of what was once a GOOD product, and hopefully this time, LISTEN TO PATIENTS.
*Want to be informed of these important blog posts? Curious what’s on Janie’s mind? Just use the Notifications to the left and below the links.
*SALE! Stop the Thyroid Madness T-shirts are now 50% off just because I like sales. A great way to spread the word about our patient revolution for the superiority of desiccated thyroid over T4-only meds. You’ll also see funny bumper stickers. Also…when you order the STTM book and request it (i.e. you have to request it), you get a Calvin peeing on….(you’ll see) bumper sticker for FREE, and it’s a hoot.
This entry was posted on Friday, July 24th, 2009 and is filed under Armour, Big Pharma Pharmaceuticals, fda, forest labs. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.
Anna said:
Jul 24, 09 at 9:59 amI was really glad to learn (from your alerts) about the reformulation of Armour, as I was just about to make the transition from synthetic T4/T3 treatment to Armour. Instead, I asked my new doctor to write the Rx for Naturethroid instead of Armour, which she was happy to do. The transition has been excellent.
J.D. said:
Jul 24, 09 at 10:07 amI, too, had heart palps. Just got on Armour in April. Apparently, my first prescription fill was old version and I felt great! Then the 2nd fill was kind of weird, some days I wouldn’t be able to take the entire dose because of the heart palpitations. Searching for heart palpitations and Armour is how I found your site! Have just recently started taking Naturethroid and I love it!
Thank you, Janie, for all your work and information.
Michelle said:
Jul 24, 09 at 12:01 pmI had also just started on Armour in Feb. and was doing extremely well-until the reform. If it hadn’t been unit dosed with the name, strength, lot, etc printed on each tablet I would have thought I received the wrong drug. Became severely hypo within 2 weeks. Had to fight with my DO for NatureThroid, then search high and low to find a pharmacy to fill it. I’ve been on a week now and still doing poorly-probably need an increase, but DO is hesitant and still in the “overly suppressed TSH is evil” mindset. sigh. Got an appointment with another doc end of August, maybe #8 is the charm?
Catryn Dromont said:
Jul 24, 09 at 12:32 pmI am always in awe of people who are able to find other doctors who will “allow” them an RX other than Levo.
Just an FYI
if you go to the Armour Tyroid site you will find that they are ALSO making Levothroid. This bothered me and still does. I guess they could not along with MD’s make enough $$$ on the real Armour.
I too, feel fatter, have higher blood pressure, my muscles and tendons kill me so I am taking Soma to help me do my regular, physical work. Could not take OTC meds as they make me feel worse. I am one of the folks who are highly sensitive to most meds.
How can we together change what is happening with Armour — as I said I am not able to find another doc and I live in Metro Denver! Yikes!
Christine Block said:
Jul 27, 09 at 6:47 amI too noticed immediately that my little Armour pill was different. The new formulation is pasty, chalky and does not dissolve in my mouth like the old version. I’m calling Forest Labs today to convey my disappointment and to let them know they need to remove the GM cornstarch from their product. I will also be switching to Naturethroid asap and let them know that! If enough people call Forest Labs maybe they will do something about this. Remember, your money talks! Take you money elsewhere and they will start to listen.
Kim said:
Jul 27, 09 at 1:30 pmJanie,
Wouldn’t the “Not FDA Approved” argument potentially affect Nature-throid as well?
I am worried that if we jump on the FDA bandwagon, we may jepoardize NT too. Thoughts?
I just switched to NT from Armour after having the same problems everyone else had. I also tried compounding my own sublingual (I got a good pharmacist, who promised me USP Dessicated Thyroid). The compounded meds were not tons better than the “new” armour. They were also 15x more expensive.
NT is a rascal to dissolve in the mouth, but so far, so good.
Christy Strauch said:
Jul 27, 09 at 5:05 pmWhen did they reformulate Armour? and how do I know if I have the newer version?
Bit of history– 2001 presented to Dr with TSH of 100, could not walk– only trudge. Gained 20 lbs in 2 weeks doing nothing differently. On and on.…I was 49, thought I was going through menopause– turns out I have Hashi’s and could have been the centerfold for Myxedema Monthly!
Went through the T4 syns and then got on Armour– was fabulous but noticed over the past few months peripheral neuropathy in my feet again! UHG.…
Sorry this is so long– any info would be greatly appreciated.
Christy
heidi said:
Jul 27, 09 at 8:11 pmI find it interesting that gluten intolerance and celiac are mentioned here. I believe I have long term gut damage from gluten that may never heal, and I went hypo on the new Armour. It took me three months to figure out what was wrong with me because I also have severe adrenal fatigue. I have been on Naturethroid for a week now and I’m getting a little better every day but still have dizziness and low blood pressure. I am on 2 grains per day but my doc said go ahead and take 3 grains if I feel I need it. I am taking it 4 times a day while I recover. Best wishes to others out there who are having a hard time with this.
Amy said:
Jul 28, 09 at 12:32 pmI’m reading on some of the forums that there are more than a few people having difficulties with the switch from Armour to Nature-throid. I personally am starting my thyroid treatment on Nature-throid and am up to 2.5 gr with absolutely no discernable difference in my symptoms. I’ve tested my adrenals and they are high in the am and mid-range the rest of the time. I hear from some that Erfa Thyroid from Canada has fewer ingredients and seems to be working better. It can be ordered online with a US Dr prescription.
Amy said:
Jul 28, 09 at 11:57 pmMy partner is on Thyroid by Erfa after having lots of issues with the new armour. She’s almost back to how she was on the old armour forumlation. It’s perhaps a tiny bit weaker, but pretty good overall we think. If you go to their website there’s a section on how to order from outside of Canada. The staff there have been very helpful. I guess it’s an option for those who aren’t doing well on naturethroid. It can also be easily taken sublingually like the old armour.
Sheri said:
Aug 02, 09 at 2:20 pmWhen we went for refills on Armour, the Pharmacy said that Armour is no longer making the thyroid medicine. What??? For now, we have the generic, but I am going to look into the Naturethroid. There are four of us on thyroid medication, so this is an important topic for us!
On the plus side, my doctor said my TSH was way too low and I needed cut my dose in half. I told her that I already have symptoms coming back from cutting back the first time. I also must have asked way too many questions for her; she referred me to the endocrinologist. That is where I wanted to go anyway. I told her, “Thank you!” I’m sure we will have a lot to talk about.
Val Birds said:
Aug 02, 09 at 8:30 pmI have recommended Naturthyroid for several years and find it is the most effective modality. One thing that too many docs do not know or remember is that TSH and other thyroid tests are not truly reliable as to the actual thyroid metablism of the patient. I still have patients take and record AM on awakening, before getting out of bed, the temp and pulse for 30 days. This routine tell will often give a better indication of thyroid metabolism than the lab tests. I note the improvement in 30 to 90 days of retesting after placing the patients on naturthroid supplemnts. One other factor, keep in mind that I have noted Nutrasweet and Splenda appear to interfer with thyroid hormone utilization. Excess of these items in sensitive persons can create a Hashimoto’s type reaction in the endogenous thyroid gland. Have other physicians noted any of this?
Kerri said:
Aug 04, 09 at 8:20 amI made it through two prescriptions of Armour before the “new” reformulation. I was feeling really good, and then I slowly began returning to my hypo symptoms-the worst being fibromyalgia. I insisted that my doctor let me try Armour, then I had to turn around and beg him for a new prescription because I can’t fill Armour script anywhere (not that it’s helping anyway). This just reinforced his idea that Armour wasn’t the best. Now I’m back to Synthroid/Cytomel combo. I don’t feel much better.
Zoe said:
Aug 04, 09 at 12:09 pmI was feeling great until the reformulation of Armour.…It was like going backwards at warp speed (Iwas on the reformulated 8 weeks). I have since, switched to Erfa Thyroid out of Canada. The Erfa is great and I am beginning to get back to my old self. I am very fortunate to have a physician that listens to me. He did not hesitate when I asked to change meds. The only set back after getting the new script was that the Canadian Pharmacy ran out of the Erfa and I had to wait 2 weeks to receive them. 2 horrible weeks of Armour. I will never go back to Armour after what they have done to my meds with no warning to me the patient, my physician or Pharmacy & I suspect no research either. I don’t trust the pharmaceutical companies anymore. Too bad the persons responsible for making the decision to make the change can’t live for a couple of months experiencing extreme hair loss, severe constipation, lethargy, and extreme joint pain that makes just going up 1 flight of stairs almost unatainable, panting after the challenge. They should have to struggle daily just to get through each day at work. Erfa says they won’t change, I can only hope this is the truth.
Andrew said:
Aug 04, 09 at 1:59 pmAfter 11 years of being hyperthyroid, I had my thyroid removed three weeks ago. After three weeks on Cytomel (fun if you like the shakes and palpitations), today is my first day on Armour Thyroid. FYI, they have it available at drugstore.com in all doses except the 60 mg (they have them listed in milligrams rather than grains), which is “on back order until mid June” (today is August 4th, and it still says that). The 300 mg has “limited supply.” The price there is less than half the co-pay my Oxford insurance would have charged if this site accepted it. If it works for me I will see if I can get my doctor to write up a much larger prescription so I can get three or six months worth at a time (cheaper by 21 cents a pill that way).
Paul B said:
Aug 07, 09 at 9:25 amHi,
I have been on Armour for around 2 years or so, slowly building my way up, decreasing my TSH, checking my T4 and T3, etc. Why slowly? Because when I was on Synthroid, my TSH was high (like 9) but I was having anxiety attacks! Stopped the synthroid and no more attacks! So I wanted to go slow on Armour. Interestingly enough earlier this spring 2009, when I was at 60 mcg my TSH was 6.6. This test was around Mar/Apr 2009. Then I went to 90 mcg for 7 weeks and it went to 8.8!!! Huh!?!? THEN I went to 120 mcg for about 8 weeks… and my TSH shot down to 0.06! I started having tingling in my head, shoulders, and arms… my fine motor skills were shot (I would reach to grab something and knock it over instead of getting it, and I used to be pretty close to a pro-level athlete with good eye-hand skills), and my muscles felt overworked (whereas when I had a higher TSH I was just very tired all the time).
What I am thinking must have happened to affect some of these changes is the reformulation of Armour. I’ve been taking the new formulation for about the last 3 to 4 months and hadn’t even considered an efficacy issue. Now I’m glad I’ve read these posts! Hopefully I can get a prescription for the Naturethyroid.
Paul
Dwayne said:
Aug 13, 09 at 11:24 amI think they are reformulating it again or putting it back to the way it was because I called today and with the exception of the two grain tablets and four grain tablets– everything is on back order until the end of September so they are doing something!
Brad said:
Aug 13, 09 at 12:39 pmMy guess is the backorder situation was planned as part of the strategy to get people to switch to more profitable synthetic thyroid.
My doctor advised me that he received a bulletin stating that the FDA required the change in formulation of dessicated thyroid medications (not just Armour).
Siobhan said:
Aug 14, 09 at 9:45 amHeidi, ultimately, if you’re gluten free, your intestinal damage will heal. I have been gluten free for a year now after endless suffering prior to that and my intestines are finally in really good shape. I’m on 5 grains of Nature-Throid, which I recently switched to after being on 5 grains of Armour for a couple of years begrudgingly.
Good luck!
beano said:
Aug 18, 09 at 6:21 pmI refilled y Armour thyroid 2 months ago without knowing they had reformulated it!
I went NUTS with cardiac symptoms– I thought I was going to die!!
In addition i had low t4 lab results and arrthymias, chest pain, extreme panic/anxiety, and much more. when i found out about this– unbelievable!
I went to a cardiologist and everything and was tortured for a month not knowing why.
now i have the stress that I cant get Armour (backorder), dont want it now, scared what is to happen, cant get Nature-throid either.
Holly said:
Aug 20, 09 at 10:10 amI’ve recently had to ask my doctor to switch me to Naturethroid because I could no longer get a steady prescription of Armour filled. I had been up to 90mg per day (I was splitting them in 1/2) but my weight and other hypo/hyper symptons were slowly returning. She put me back on 3/4 grain, which was close to the 45mg that was originally prescribed. I started out okay but went into depression and more weight gain after 3 weeks. I said screw it and started taking a whole grain and feel tons better practically overnight. Now, how do I tell my doctor that I do better on the 1 grain? My original endocrine moved out of state, but he thought that I did better with a lower TSH, and I agree. My doctors are osteopaths and very good — my main doctor listened to me when I explained that I needed to be on natural thyroid medicine because I wasn’t “cured” no matter what the TSH said. My thyroid has had bouts of inflamation all my life and that I was feeling it happen again. He now sees that I am doing much better with the meds than I was without them. Do I try to email him where he works now to email my doctor? That sounds kinda stalkerish, but I am desperate to continue to feel great.
Tess Davis said:
Aug 21, 09 at 7:43 pmI have been on Armour Thyroid for over 10 years. I have been stable and not experiencing the typical hypothyroid symptoms. During the past several months my training for a 1/2 marathon and a mini tri has come to a halt. I have been experiencing extreme levels of exhaustion, moodiness, body aches, headaches,difficulty in breathing, chest pain, heart palps, the list goes on.…I did not relate any of these “typical symptoms” to my hypothyroid because I have done so well on Armour Thyroid.… until this morning!Today I just found out that my armour thyroid prescription could not get refilled. I also found out that my armour thyroid medication had been reformulated earlier this year. Who knew that the manufacturer can just change a formula? This is madness! Why doesn’t this type of information get out into the media when tens of thousands of armour thyroid patients have been mislead and they have put our health at risk? I wonder how many people have lost their life due to heart attacks with this re-formulation? I will start Nature thyroid tomorrow and will pray that I re-gain my life, my health and my mental well being.
Judith said:
Aug 25, 09 at 6:23 amIS THERE GOING TO BE A CLASS ACTION SUIT FILED AGAINST FOREST LABS?
Julie said:
Sep 10, 09 at 6:10 amThey are now making a gluten free medication by Lannett and JSP…check it out. I have found it in walgreens. There is no “brand name”..I believe it is a generic.
(from Janie: Interesting. Lannett and JSP are also the makers of gluten-free Unithroid, a t4 medication from way back.)
diane said:
Sep 26, 09 at 5:38 pmI have been on armour for 8yrs and feel great!!Since my last refill I got the refomulated armour and feel so bad just like I did when I was on T4. I don’t know what to do There is a big difference between the two. I get such bad heartburn from the new armour just like I did with the T4 I went through hell for almost 2yrs and when I made the switch to armour no more heartburn.. Now it’s back with the new armour – and I never had heartburn. So I don’t know what it is that gives me the heartburn in the new armour. Can anyone help? Diane
Heather said:
Oct 15, 09 at 3:04 pmIt took me awhile to get the new Armour. I guess my pharmacy had old stock somehow. When I finally got it my symptoms returned with a vengeance. I felt sicker than I did when I was undiagnosed with hypothyroid.
I just got my first bottle of Westhroid. Naturethroid was out of stock. People have been asking if you can take it sublingually. I bit it in half and put it under my tongue and it did dissolve. It’s kind of gritty and sandy but I didn’t get any awful taste. I’m not sure if it will absorb the way Armour did because it didn’t melt like the old Armour but it did dissolve.
Is anyone else doing Westhroid or Naturethroid sublingual?
Heather said:
Oct 15, 09 at 3:05 pmThis is for Diane, if you are coming back and reading. My heartburn and IBS symptoms were due to hypothyroid and went away when I got on Armour. With the new formula they all started returning, so maybe it’s a hypo symptom.
diane said:
Nov 02, 09 at 12:12 pmThanks Heather, I have terrible heartburn from the armour and don’t think its low TSH something in the new fomulation. I will get a new blood test done. I just got this message and wish I got it earlier. Diane
Dorie said:
Nov 11, 09 at 12:45 amWhy isn’t there a class action lawsuit against Forest Labs? Aren’t there any lawyers who have taken the reformulated Armour and have tanked like the rest of us? This needs to get started, please if you are a lawyer start the suit NOW.
marylyn said:
Nov 15, 09 at 9:46 pmI switched to Armour Thyroid this year and began experiencing odd symptoms…left side of chest under cartilage soreness which I have never had, fibromyalgic pain which was extreme and have not had for many years, unusual fatigue, eye burning, and unusually low blood pressure and heartbeat, although rarely. Underwent stress test, ct of abdomen and pelvic area, general blood testing (thyroid not included)…all normal. It was an enigma to my doctors. But yesterday found out, thanks to website, that my thyroid med was reformulated without my knowledge.
I stopped taking it today, will switch to Naturethroid for now (if I can get it at Walmart or someplace) and see if my weird symptoms go away. If they do, God willing, it will point to my being given a medication my body requires that has been changed without my knowledge and did harm to my body, mind and spirit. Additionally, the reasons given on-line at several sites for the reformulation seem lame to me, and I seriously question anyway the source of the cornstarch as there are no safeguards in place for production in places like China and it could have been contaminated. Also, what precipitated the FDA demands at this point in time. And, why is no-one taking samples of the new product and bringing them to an objective laboratory for analysis, i.e. toxic ingredients, or variance of hormones in tablets…some could have zero and some proper, low or high amounts. This needs further research for the safety of millions. And if the manufacturer has been ethical, they would be exonerated of any fault in the safety and content of the product. However, they are still to be seriously faulted for not informing the medical and pharmaceutical community who are supposedly in place to protect the population, and, very importantly, the people themselves who have a right to know what they are consuming in their bodies. Particularly if it is a medicine purchased to maintain their health. Thanks for this website. Will let you know if stopping the med stops the symptoms.
Jackie said:
Dec 12, 09 at 3:47 pmI decided to try Nutri-Med dessicated porcine thyroid I read about from this website. I thought at first I was feeling ok. Then slowly symptoms started returning. Had TSH test done and Dr said it was off the charts! I now found a compounding pharmacy in my area that mixes a similar version of T3 and T4 equal to Armour thyroid. My insurance is even covering this since Armour is still unavailable. Just started it this week, so too soon to tell if it’s working. Even if Armour were to become available, I will never rely on taking it again. They have lost my trust.
ellen weir said:
Feb 10, 10 at 7:17 amI’ve been on Armour thyroid for over 20 years, and for the last several months, have gotten severely constipated, tired, and bloated. No doctors here seem to understand hypo and digestion. I am very upset that Armour has reformulated, but if it were not for this website, I wouldn’t have known it. I have been on liothyronine 5 mcg(2x), and Levothyroxine, 150 now after taking 120 for 20 years. not feeling to well, and not sure i have a doctor here who will prescribe Naturethroid…any suggestions. ellen
(Ellen, it may work better for you as far as feedback to post this on groups: http://www.stopthethyroidmadness.com/talk-to-others and to look for a better doc to get Naturethroid, which is good and appearing on shelves in 2 – 2010: http://www.stopthethyroidmadness.com/how-to-find-a-good-doc )