Probably most people have heard about “drug recalls”, but may not know the ins and outs about recalls.
What is a recall?
I personally think the best definition of a drug recall comes from the Saunders Comprehensive Veterinary Dictionary1: a voluntary action of removing a product from retail or distribution by a manufacturer or distributor to protect the public from products that may cause health problems.”
Note the word “may” cause. Recalls can also be about risk, not just about definite adverse consequences.
So a recall is voluntary by a pharmaceutical?
It definitely can be. And it can also be at the request of the FDA. Either. From the FDA2: Drug recalls may be conducted on a company’s own initiative or by FDA request. FDA’s role in a recall is to oversee a company’s strategy, assess the adequacy of the recall and classify the recall.
What are reasons for a recall?
WebMD3 defines five potential reasons:
1) it’s a hazard to your health
2) it’s mislabeled or poorly packaged
3) it’s potentially contaminated during production or distribution
4) it’s not what it says it is
5) It’s poorly made, effecting it’s quality, purity, and/or potency
For #3 above, note that the potential contamination may be harmful OR non-harmful.
Are recalls common?
Believe it or not, yes! A 2017 article in the Journal of the American Medical Association4 stated that 1/3 of all prescription meds have been recalled due to “safety events”.
If something I take has a recall, what do I do? Can I get my money back?
Yes. But you do need to call the pharmacy from which you got it, first. They have to get official notification of the recall before giving that refund.
Shouldn’t I get a replacement for my prescription medication before taking it back?
Call your doctor so he or she can prescribe a different one before you return your recalled medication. That way, you can pick it up at the same time you return your recalled medication, say experts.
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Now let’s move to a recent recall of one particular natural desiccated thyroid medication by Westminster Pharmaceuticals.
Westminster came out with its own natural desiccated thyroid (NDT) product, considered a generic version, in late 2017. You can read more about their NDT product on Stop the Thyroid Madness’s page which lists brands and ingredients, here.
Westminster voluntarily issued a recall of their NDT in August 2018 due to “risk of adulteration”. See below.
Why did Westminster voluntarily issue a recall?
The recall states it was done “as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Manufacturing Practices (cGMP). Substandard cGMP practices could represent the possibility of risk being introduced into the manufacturing process.”
It’s important to point out the words “possibility of risk”. That is different than a definite negative outcome as having occurred. But time will tell.
And if you really want to get into detail about why the FDA issued an alert about Sishuan Friendly Pharmaceutical, the maker of desiccated thyroid powder that Westminster was using, it’s all here.
How do I know if my particular bottle of Westminster’s NDT is part of this recall?
The recall notice lists many lots. You’ll need to call your pharmacist to see which lot your bottle came from. But it does appear that most of Westminster’s NDT has been recalled by the long list of lot numbers.
Has anyone been harmed by their use of Westminster’s NDT?
In the 2009 recall wording, it was stated “To date, Westminster Pharmaceuticals has not received any reports of adverse events related to this product.”
Is this the first time that any thyroid medication has been recalled?
Nope. For example, Levoxyl, a T4-only medication, was recalled in April 2013. Synthroid, another T4-only medication, has been recalled numerous times due to issues like subpotency and the same failure to follow good manufacturing practices.
Is 2018 a year of Natural Desiccated Thyroid mishaps??
Boy oh boy, it sure has been.
First, RLC’s Naturethroid and WP Thyroid ceased production in 2017, and Naturethroid only started creeping back in 2018. But sadly in 2018, there seem to be quite a few patients reporting it to be far weaker than it used to be and finding that out the hard way with the return of major hypothyroid symptoms. Some are trying to raise it to see if they can regain their former feel-goods; others have been switching to other brands.
Then comes this with Westminster’s NDT. What a mess.
Is there a conspiracy at foot to take our NDT away?
No, it does not appear to be conspiracy.
My doctor claims these recent issues prove that desiccated thyroid is unreliable and I should use Synthroid. What do I say?
You say “What is proven by millions over the years is that T4-only like Synthroid is the unreliable way to treat hypothyroidism”.
So where do I turn now?
People have been moving over to NP Thyroid by Acella, or Armour. You can also choose to have your NDT compounded. Or move to synthetic T3 with synthetic T4. But the goals are the same, which for years includes seeking a free T3 towards the top part of the range, and a free T4 midrange. Both. And to achieve the latter, it’s still important to have the right amount of cortisol and iron, we’ve learned repeatedly, because if you don’t, you can see problems. Too often, people blame their problems on NDT, when in reality, it’s what NDT or T3 reveals that is the problem.
Footnotes:
1. Saunders Comprehensive Veterinary Dictionary, 3 ed. © 2007 Elsevier, Inc.
2. https://www.fda.gov/Drugs/DrugSafety/DrugRecalls/ucm612550.htm
3. https://www.webmd.com/a-to-z-guides/what-is-a-drug-recall#1
4. http://jamanetwork.com/journals/jama/fullarticle/2625319
Important notes: All the information on this website is copyrighted. STTM is an information-only site based on what many patients worldwide have reported in their treatment and wisdom over the years. This is not to be taken as personal medical advice, nor to replace a relationship with your doctor. By reading this information-only website, you take full responsibility for what you choose to do with this website's information or outcomes. See the Disclaimer and Terms of Use.
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99 Responses to “All about Drug Recalls and what happened to Westminster’s Natural Desiccated Thyroid”
the_pan
So I was able to find out where to get Thiroyd for cheap through this site. Anyone know where I can get Cortef? In Canada it’s costing me like $400 a month for 30 mg a day and I have no coverage.
Timothy
I am just starting on NP Thyroid. I am concerned that I will not be able to titrate up due to shortages. Is anyone else having difficulty finding NP Thyroid? Thank you.
Janie Bowthorpe
NP is very available. They have just been slammed and you have to call around to find it.
Tracy
Hey Janie I’m sorry to hit “reply”, but I’m on my mobile and can not find anywhere to submit a new comment.
Anyway, two questions:
1). Do you find some people do better on an NDT and T4 combo rather than T3 and if so why?
2). I’ve had a harder time finding NDT available for compounding as I can’t take the fillers in other meds. Is there more than one importer of raw NDT than Sishaun? Is there differences in the raw product via different distributors (Hummco, PCCA) or is it all the same and the fillers used per pharmacy are the only difference? So hard to find this information. Thank you!
Janie Bowthorpe
1. There’s no need to add T4 to NDT. NDT is already 80% T4. In fact, by doing so, you now risk RT3 going up.
2. There are others who make the NDT powder….many in China. See Alibaba website.
Angela Morris
I went to CVS today in my hometown and they did not fill my NP 120 dose. The pharmacist told me that they are now blocked from ordering NP thyroid. He is no longer allowed to purchase it. I don’t think this has to do with the lab that makes NP, but CVS/Caremark is no longer allowing it to be ordered.
Janie Bowthorpe
That is disgusting.
Angela
This is on Acella’s NP Thyroid website:
NP Thyroid® is Available & Not on Backorder
Availability at CVS Pharmacy
We have heard from prescribers and patients about the decision that CVS pharmacy has recently made to no longer stock NP Thyroid® at their pharmacies. While we have no say in how corporate pharmacies make decisions that impact patient care and the availability of prescription products, we want to assure our customers and prescribers that NP Thyroid® is NOT on backorder and is available at any pharmacy throughout the USA through their wholesalers, including CVS.
NP Thyroid® tablets are one of the most consistent, available and cost effective Natural Desiccated Porcine Thyroid tablets (T4 & T3) available by prescription. We respect the choices that licensed healthcare prescribers and patients make when choosing appropriate therapy. As a licensed healthcare prescriber or a customer, you have the ability to request that CVS continue to fill your prescription of NP Thyroid® as prescribed and not allow any substitutions OR you can choose to have your prescriptions transferred to another pharmacy in your area that is committed to prescriber, patient and customer satisfaction. We would recommend you check around to local pharmacies in your area and compare prices on http://www.npthyroid.com or http://www.goodrx.com to find the best option for you then notify your CVS pharmacy of your request to transfer your NP Thyroid® prescription.
Janie Bowthorpe
Which means….PUT YOUR MONEY INTO PHARMACIES that are smart enough to get your NP Thyroid…
Heidi Horton
I have also had a lot of issues getting my NP Thyroid. The 120 and 90 have been very hard to find. I do like it though. Soooo first to call another load of pharmacies
Janie Bowthorpe
You need to see the latest few blog posts about what happened to NP Thyroid.
Alex
Hello Janie,
I just did want to order my NP again and my pharmacy says- there are available 0.25 and 0.5 grain only… Is now also NP unavailable? It’s the real catastrophe what happens with NDTs!!!
Thanks for ansvering in advance
alex
Janie Bowthorpe
No, no, it’s available. Understand that Acella is being bombarded now with what happened to Naturethroid and Westminster. So it can be a little slow, but it’s available. Also try calling other pharmacies.
Alex
Thank you Janie… I hope so much it works with NP. I asked my pharmacist to call Acella. I am waiting for his reply. Thanks a lot again!
Alex
Janie Bowthorpe
Alex, it works! 🙂 Just make sure your iron and cortisol are where they should be to prevent problems. STUDY: https://stopthethyroidamadness.com/natural-thyroid-101
Paula Browne
My doctor can’t find a Pharmacy that carries Acella. Any suggestions? I’m in Riverside County Ca.
Janie Bowthorpe
Give any pharmacy the number to call Acella—Acella will explain to them how to get it! (678) 325-5189
Paula
Thanks Janie!!
ANN
Hi Janie,
A question about multi dosing NDT….I recently got my doctor to agree to multi dosing my medication. I take it at 4 am as we get up at 5 and I want to drink coffee first thing…knowing I get up that early approximately how many hours after that should I be taking my second dose? Thanks for all you do! Ann
Janie Bowthorpe
FYI: your doctor has no control over whether you multi-dose. That’s between you and you. Take the power! But if you mean you got extra meds, great.
Probably around 10 am is a good time for that second dose if you are taking the first that early (i.e. 4 am). Hopefully you are optimal to prevent afternoon sleepies. 🙂
Nancy
I am thyroidless and was on a compounded NTH and doing well. I phamicist filled my script with a synthetic to try to trick the ‘thyroid’. My temp went down to 77F. I have been on on older product for 4 weeks now and cannot keep my temperature up.
Treating adrenals. Very frustrating.
Lane Bartel
Do you think it’s possible that if cortisol is low and T3 pooling because of it, that when I take hydrocortisone and my body finally starts using T3 I might actually have to up my NDT? Trying to figure out if I can trust my labs to stay on my current NDT dose or if I will have to play with it while I raise cortisol. I don’t want to adjust my NDT and get a bad result if I shouldn’t touch it while on cortisol. Thanks
Janie Bowthorpe
We’ve learned the hard way NOT to start on HC if we are pooling i.e. to lower our T3 or NDT meds in order to lower the pooling first. Why? Because over the years, if someone started HC or ACE with high free T3, it RUSHES in to the cells and makes us miserably hyper for a coupla days. Then we raise. Hopefully you are studying Chapter 6 in the revised STTM book. Very important.
Ann
Hi Janie,
My question is related to Ancella thyroid np. If I take it sublingually in the morning and early afternoon and it goes directly into the bloodstream would it be reasonable to assume you could have coffee after it has dissolved or do I still need to wait the full hour? Thanks for all you do. Ann
Janie Bowthorpe
Pretty sure that even those who do it sublingually are swallowing some of it, too. But…there are lots of people who still drink coffee and say they haven’t had an issue.
Helen Lease
I had been on Westhyroid for years and I did great. Then they stopped making it. So I moved to Armour. I was doing o.k. until I ended up in the hospital for a blood pressure medication that was recalled and the doctor couldn’t regulate my b.p. with new meds. While in the hospital they increased my Armour from 90 to 120 mg daily. I have had sleeping problems and restless legs but before going into the hospital it was gotten so much better, almost no problems at all. Once they increased my meds to 120mg daily it all came back. My endo doctor has moved me back down to 90mg daily but I am putting on weight like crazy, still not sleeping and the restless legs are driving me crazy. What do I do 🙁
Janie Bowthorpe
And you also need to study this page: https://stopthethyroidmadness.com/ndt-doesnt-work-for-me
Violet A.
Hello everyone, I am new to this site and relatively new to Natural Desiccated meds. I was reading some of the blogs and need help. As many of you I requested to be switched from a synthetic to Nature Throid and when the shortage occurred they switched to Armour (it was horrible for me) and finally to NP Thyroid which seemed ok for me. Now again there is a shortage of NP thyroid ugh….every time they switch my meds my body reacts in a negative way initially. I am extremely sensitive and need some consistency. Do know what to do at this point..any recommendations, please help!!
Janie Bowthorpe
There is not a shortage of NP. You just have to get your pharmacist to call Acella. Or check other pharmacies for stock.
Angela
Hi Janie,
I have been having trouble getting NP Thyroid this month. I did as suggested and reached out to Acella. Below, is the email I received back from Acella regarding the supply issue. I thought your readers would want this information. In addition, I have included information that the FDA put out regarding Sichuan Friendly Pharmaceuticals in the early part of September this year. That company has now recalled all of their product, not just the original Westminster product, which could explain the reason so many labs are having trouble getting the porcine powder. Acella doesn’t fall in that category, but it could explain the issue with Women’s International and other labs. I sure hope this all resolves itself sooner than later. This year, Carefirst Caremark removed all NDT medications from their formulary, so all of them are out of pocket now, if you have that insurance. I found that NP Thyroid is the cheapest to purchase of them all, with a GoodRX coupon.
Copy of email from Acella Customer Service
Due to the very high demand for NP Thyroid tabs, we have had to move to a system of allocating what we can supply to our wholesale customers. Here is what this means:
Because of the recent events with other desiccated thyroid tablets being recalled or unavailable, the demand for NP Thyroid has increased to a level that is unprecedented. In order to ensure that there will be continued, regular supply of NP Thyroid tabs over the coming months, we have elected to carefully allocate the amount of NP Thyroid tabs available to wholesalers and to the retail pharmacies. Because of this, there may be instances where pharmacies may not be able to fill an entire order for NP Thyroid tabs.
Within a short period of time, under this allocation system, all orders for NP Thyroid tabs will be filled.
From a consumer’s viewpoint, this means that you should consider placing your refill order for NP Thyroid when you have about two or three weeks’ supply on hand. This way, if it takes the pharmacy two weeks to receive its supply of NP Thyroid, your refill will be filled before you are out of your medicine. In addition, you may want to search other pharmacies in your community for availability if your primary pharmacy is out of stock.
NP Thyroid is not currently on “backorder.” “Backorder” means that a company is totally out of stock of a particular item and cannot fill any orders for it. Acella Pharmaceuticals is not in that position. We continue to purchase the API (Active Pharmaceutical Ingredient) that is sourced and manufactured here in the USA to make NP Thyroid on a regular basis. Acella is working diligently to ensure a stable, reliable and consistent supply of desiccated thyroid tablets and hope to have this situation resolved in near future. Thank you for your patience and understanding.
Copy of recall on the FDA website for Sichuan Pharmaceuticals
FDA alerts drug makers of a recall of porcine thyroid API from Sichuan Friendly Pharmaceutical Co., Limited, China
FDA testing confirms inconsistent potency in the active ingredient
Update [9/5/2018] FDA is alerting active pharmaceutical ingredient (API) repackagers and distributors, finished drug manufacturers, and compounders that Sichuan Friendly Pharmaceutical Co. Limited, China, has recalled all unexpired lots of porcine thyroid API due to inconsistent quality. FDA recommends that companies check their supply and quarantine any API from Sichuan Friendly.
FDA reminds manufactures and compounders that Sichuan Friendly API may not be identified as the API manufacturer. The API may also be labeled as Sichuan Beisheng T, Sichuan Beisheng Trading, Sichuan Beisheng Technology or another API supplier.
Judy
It’s really tragic and unfair that so many thyroid patients are needlessly suffering and struggling, not to mention taking a major financial hit (added medication expenses, lost income, and so on) through the mess that’s happened with various off-the-shelf and compounded products. In 2018 in a modern country like the U.S., there should be plenty of quality options that allow people to lead a normal quality of life, work, raise kids, contribute to society, etc. What’s been happening with NDT meds for at least 10 years with many products is simply ridiculous. Something has got to change. But how? How can we all band together and create change? It is just unbelievable how bad thyroid care and options still are in the U.S. The lack of medication options and lack of knowledgeable, compassionate doctors is really tragic.
Ulrike
Very well said
Marty
Does anyone know where you can get NDT compounded. My TSH and T3 especially have been on a roller coaster since moving to compounded synthetic and small amount of WP. I do not do well with fillers that is why I took the compounded synthetic. Then my TSH was 60.2. Added 1/2 grain of WP, now TSH is .01 and T3 is 4.75. I have bowel issues, stomach discomfort, back pain and more. Any thoughts.
Marty Gerace
I have received notice that my NDT used by Womens International Pharmacy has been recalled. I’ve had it compounded for years.
Judy
Marty, I got the same letter in the mail that it sounds like you got. I received it yesterday, the same day that I called to order a refill and was told WI was not shipping any refills. Like you, I too have been on the med from Women’s International for years. I’ve even been on the same exact dose with labs including TPO antibodies looking good for years. Now I’m having to scramble and figure out a different option with only a few capsules left in the bottle.
A few months ago you probably were aware that Women’s International starting rationing off med and only allowing patients to order 30 days at a time. So all their customers are in the same boat now, stranded with less than a couple weeks worth of meds, trying to figure out a different option.
It really gets me that the letter Women’s International received from their supplier was dated Aug 22, they got around to writing a letter about the “urgent” recall 1 week later on Aug 29, but I didn’t even receive that letter until Sept 10. They should have given patients more lead time to find a different option.
Now I’m faced with no good options. My dr is hesitant to have me take any med that has fillers because he thinks I might not do well on them, which is a big reason I do compounded in the first place. I have to either do an off-the-shelf product with fillers (and it sounds like NP is the only good and available one, but it has mineral oil) or change from NDT, which I’ve been taking for many years, and use synthetic compounded T4 T3.
Crazy that in 2018 we can send satellites into outer space but can’t figure out how to keep a quality steady supply of a raw material (NDT) that’s been around for many decades. In the process of all this,
I also found out that the raw material compounders have been using is imported from China!! And it sounds like currently, the recall is affecting all compounders in the U.S., which means no thyroid patients can get compounded NDT. It also sounds like the recall might not be resolved really soon. I’m just speculating and don’t know that for a fact.
I’m also wondering how the recall ties in with what’s going on with Westminster (sounds like the same recall) and Nature-Throid (maybe why patients aren’t feeling well on it is that the raw material is inconsistent quality, which is what caused the NDT recall).
Jeffrey
https://www.reuters.com/article/us-usa-trade-china-pork/trade-war-puts-the-hoof-into-u-s-pig-part-exports-to-china-idUSKBN1K71EA
Same letter for me, connect the dots….im having WIP compound synthetic T3/T4….no need to worry about fillers, NP was terrible for me …..dont think this will be resolved any time soon imo, who needs the anxiety of chasing down thyroid meds every few months?
Janie Bowthorpe
Jeffrey, you need to find out why you did terrible on NP, because the reason will be there will the synthetics. Read this: https://stopthethyroidmadness.com/ndt-doesnt-work-for-me NP is an excellent product, and doing terrible has to do with other issues as the latter page explains.
Jeffrey
The link is in reference to why we dont do good on NDT. Thats not the case for me, i do great with them as long as there isnt/or minimal added fillers …..NP has added fillers and my body didnt like it. With a compounded synthetic, oil of my choice, im not getting added binders/fillers so i will let be the test of how my body reacts..
Janie Bowthorpe
Jeffrey, just remember the link. We do know that a small body are sensitive to fillers, but we also also see a much higher body of people who don’t do well due to what is in that link. Hope it works for you.
Jeffrey
…2 tablets of NP to get the same dose of my WP….equals double the amout of calcium stearate, dextrose and mineral oil. NP might be a good product for some but not me so i have to disagree with you on the link you referenced. We can chase the “whats wrong”and numbers as far down the rabbit hole as we like but paying attention, focused awareness of how “I feel” has been the most effective for me
Janie Bowthorpe
Again, just keep it in mind, as too many have those issues.
Marty Gerace
I’ve been to my doctor and we are going to try the synthetic T4 T3. At least it can be made without the fillers, only with the olive oil and veggie caps. Hopefully that will hold me over until a safe source can be found, but I fear that will he a long haul. I’ve used NDT since I was diagnosed in 1998. Began with Armor, then NDT with probiotics as filler. My system is just way too sensitive.
Judy
Marty, did you start synthetic T4 T3 yet? Are you getting it from Women’s International? How are you doing on it so far? I switched to synthetic T4 T3 too. I’m only on day 2 of it, but so far it’s OK and some “side effects” I had developed on NDT compounded seem to be clearing up. I didn’t know what was causing those symptoms for sure. I wouldn’t have guessed it was NDT causing those symptoms, as I’ve taken NDT successfully for many years from Women’s Intl. Getting more and more concerned about the quality of NDT from those companies in China.
Jeffrey
Synthetic T3/T4 compounded from Womens International also….few days in and responding nicely. The NDT shortage situation is not going to clear up anytime soon so this seems like the best option. NP Thyroid sucked for me, felt terrible on it. WP was awesome while it lasted but as life goes, all things are subject to change. I must say I give Womens International Pharmacy 5 stars, they are really knowledgeable and helpful, also refunded me fully for my last NDT they compounded after the recall. Best wishes…..
Janie Bowthorpe
Hi Jeff. Whatever caused you to not to well on NP will still be there on the two synthetics, sooner or later. NP is a great NDT and feeling poorly is either due to underdosing, or it’s revealing of low iron and/or a cortisol problem.
Judy
Hi Jeff,
Glad you had good experience with Women’s International. Whereas they have always been friendly, pleasant, and knowledgeable in the almost 9 years I’ve been ordering from them, some of the pharmacists were quite rude and defensive toward me since the recall started. And they only refunded me a measly amount for the capsules I had left in the bottle even though I asked them to refund me for the bottle at least. They should be treating all their customers the same. I would have given them 5 stars before. I don’t appreciate how they handled the recall and many other things in recent months. I don’t know if they got some new pharmacists or what, but some of the ones I talked with last week I had never spoken with before. Those were the rude ones. But I’ve talked with pharmacists there who have been working there for more than 20 years. Those ones have tended to be more pleasant. The technicians are usually consistently pleasant though.
Hi Janie,
Could Jeff be reacting to the fillers in NP, and that could explain why he was doing well on compounded NDT (if he was doing well on that) but not NP and also why he’s doing OK on synthetic T4/T3 with just olive oil as a filler? One of the pharmacists at Women’s International a while back mentioned fillers and how some people don’t do well on them. What are the tests to do for low iron?
I really think my problems in recent months with NDT were more like side effects. I never knew NDT could cause side effects. I was doing fine on that same dosage of NDT from Women’s International for 8 years. The symptoms I started having suddenly started happening around the same time that WI apparently changed their supplier, around May, and I don’t think that’s a coincidence. Another person mentioned in the comments here having some digestive issues starting around June that are still occurring.
Some of my most recent capsules of compounded NDT I got have small black pieces in them, almost looking like specks of dirt, whereas the material inside the capsules always looked more of a tan color. I wouldn’t think there would be any black in NDT. Also, around the time I started having symptoms was at the same time I received an NDT refill that contained capsules that look different from each other. That is, some of the capsules inside that bottle were a darker color than others. They didn’t all look the same as each other. I called the pharmacist about that. After that, they started putting a sticker on the bottle referring to that difference in appearance of the capsules.
One of the main symptoms I started having every single night in May was insomnia. That symptom discontinued the very first night that I stopped taking compounded NDT. I have slept fine and just like I always have every single night this week since I stopped taking compounded NDT. Really weird. As I said, I don’t think it’s a coincidence that various symptoms started at the same exact time that something changed with Women’s International’s raw material in May. I had never had those types of problems in 15.5 years on NDT.
Janie Bowthorpe
Though most dont react to fillers, that’s a good point about the fillers. Worth looking into.
Jeffrey
Janie do you have any affliation with Acella? You seem to really promote the NP??? I said this in every other post, I reacted to NP fillers, period. There is no other mysterious problem, my body loves NDT when its not loaded with binders and fillers. We can chase numbers and test down the rabbit hole as far as we want. Learn to listen to your body, it will tell you whats up. To say i will have a problem with synthetic later is careless in my opinion and there is no reason “to figure out why NP didnt work” …. there is 3 reasons and they are on the inactive ingerdients label.
Janie Bowthorpe
Jeffrey, a pharmaceutical is not allowed to have an association like that. I mention it because it works when so many are not.
Janie Bowthorpe
And no, it was not careless. MANY people don’t understand being optimal, nor the problems you can encounter with low iron/ low cortisol.
Janie Bowthorpe
And finally (I’m in a weak internet area at the moment, so posting short things to make sure they get through)…though it’s a good thing to listen to your body, it can also get you into trouble with NDT. We will feel great on non-optimal doses..but eventually it will backfire due to suppression of one’s feedback loop. Thus, labs (free T3 and free T4) are VERY important to find optimal. Listen to years of patient experiences.
Jeffrey
I am 90% sure what we are seeing with the shortage is due to the trade war. i just recieved a letter from Womens International Pharmacy recalling the compounded meds I have only been on 2 weeks after my WP stash was all used up. Soooo…the copy of the recall letter is from a company in China who also supplied Westminster. A little bit of google-ing and connecting the dots, there is a few articles from early July stating that basically the US sells its unused pig parts to China, its used in many dishes where we see it as not eatable. Guess what that includes???? So now as part of the trade war China is no longer buying these “pig parts” from the US hence there is no supply of NDT…im not trying to spin “conspiracy theories” but all signs are pointing to a long haul before its readily available again unless its coming from countries not involved in this hoopla. I decided to have a compounded T3/T4 synthetic to match my WP. Im over this whole mess, plus NP has to many fillers….made me feel terrible….onward and upward folks, be well 🙂
Deb
This is really a real thing. China is becoming more in control of United States RX. And this is scary. No regulation. Just read a article how they control our pork supply. Again scary. And maybe some answers to why we can’t get good NDT anymore. Very sad. But TRUE.
Janie Bowthorpe
To the contrary, there is regulation, in that the FDA does inspect facilities that a US pharm may use.
Deb
Unlike American drug manufacturers, China operate under different rules, nowhere near the quality control as in the US
Have you read the book China RX by Rosemary Gibson?
Judy
This article says the companies in China are not always inspected:
https://www.usnews.com/news/best-countries/articles/2018-05-08/trumps-quest-for-lower-drug-prices-may-provoke-china-trade-war-experts-warn
Here’s a paragraph from that very eye-opening and alarming article:
“The safety of the U.S. drug supply is another concern, because the Food and Drug Administration lacks the funding and personnel to inspect Chinese factories, which may be forewarned of the inspectors’ arrival. The most terrifying example involved a contaminated blood thinner, called Heparin, distributed by Baxter laboratories in 2008, which killed 81 people and sickened nearly 800 more.”
I’ve read the same in other sources. I’ve read that the FDA has hardly any people working in China and that China has been resistant to them operating there. Very bad situation, to make a huge understatement.
Here are other quotes from that article:
“China has exclusive manufacturing agreements for drugs for anesthesia, cancer and HIV/AIDS, along with other medicines that “we use every day, not only in hospitals but in our own medicine chests,” Gibson says, adding that China is now the world’s only source of antibiotics, including the main ingredient in vancomycin, a treatment of last resort that is used by patients who are suffering from infections that are resistant to other treatment.
“It’s a huge dramatic shift and nobody knows about it,” Gibson says. “And they’re just ramping up. It’s all part of a plan that China laid out in its 2025 initiative to become the pharmacy to the world.””
And here’s another article:
https://www.theepochtimes.com/china-manufacturing-of-most-us-medicine-and-vitamins-poses-security-threat-researchers-say_2497862.html
Quotes from that article:
“The Food and Drug Administration (FDA) is inspecting only a small number of the Chinese companies that manufacture U.S. drugs, and those it does inspect are often found to have serious health violations. Meanwhile, the drugs that are making their way into the United States from China, either as finished products or as ingredients, are often falling far below U.S. safety standards. And some of these drugs are not being inspected at all.
The failure of Chinese drugs to meet U.S. quality standards is exacerbated by the volume of imported drugs. China has become the primary source of many crucial medical drugs, including penicillin, heparin, and medications essential for surgeries.
This supply would be placed in jeopardy if a dispute were to erupt between China and the United States. If the supply chains are cut, crucial medications would stop reaching Americans”
Read the section of that article “Lack of Inspections” and here are some quotes:
“The FDA was ill-prepared for that new reality. Gibson and Singh note, “The FDA was created in 1906 with the belief that America’s medicines would be made in the United States.” The FDA was not set up to inspect foreign facilities on a large scale–and Chinese drug plants went out of their way to make inspections exceedingly difficult.
“Drug company executives at home complained to the FDA about the uneven playing field. It was unfair that they were constantly inspected while businesses shifting production abroad to China were hardly ever inspected,” the authors write. These warnings, however, went largely unheard.”
+++++++++++
A book was published in April that addresses the topic of drugs being imported from China and how the U.S. is very dependent on drugs from China:
https://www.amazon.com/China-Rx-Exposing-Americas-Dependence/dp/1633883817
China Rx: Exposing the Risks of America’s Dependence on China for Medicine
Deb
Thank you Judy: So glad someone brought this to everyone’s attention. I have appointment with Dr. next week to make the switch, hopefully all my issues I’ve had with NDT clear up too. As I have trusted them for 15+ years.
Judy
Deb, you’re welcome! Same here, I’ve been taking NDT for 15.5 years. What kinds of issues have you been having with NDT, and for how long?
Two nights in a row this week so far, I slept just fine, and the insomnia went away the very first night after I stopped taking compounded NDT. I’m still feeling hot more than usual, but I’m hoping that will clear up too. When I get that hot feeling, I also get really weak and sweaty all over at the same time. It’s pretty scary and has been happening every day. Those two symptoms started suddenly in May, apparently at the same time that the Women’s International product became questionable. The pharmacists insist to me that their NDT was testing fine was 3rd-party testing, but I disagree, based on horrible symptoms I’ve developed.
I hope you feel better really soon, if you have been having symptoms! What meds do you think you’ll change to? I changed to synthetic T4/T3 compounded, but I really don’t want to take synthetic. I notice so far that my energy is not sustained and long-lasting through an entire day like it is with NDT. Soon after taking it, I get a big burst of energy like I’ve had several cups of coffee, and then as the day goes on, my energy and stamina tank. That didn’t happen with NDT. My energy levels were more even through an entire day.
Have you read China RX? I just found out about it the other day, and it sounds really good and gets excellent reviews.
Judy
I had to scramble last week once I received the letter from Women’s International announcing the recall. I had no good options for a different medication. I’ve heard about the problems with Armour and Nature-Throid. No way would I go to T4 only. I’ve been taking compounded NDT from Women’s International for many years. I’m concerned about any and all fillers, and so is my doctor. The pharmacist agreed that some people don’t do well on fillers.
So I had it narrowed down to either NP or synthetic compounded T4/T3. I really didn’t want to go to synthetic after taking NDT for 15.5 years. But I didn’t think I’d do well on the fillers in NP. I’m only on day 2 of synthetic T4/T3, so I’ll have to see how it goes. But some symptoms that started suddenly in May are already clearing up. For example, feeling very hot much of the time, really bad insomnia, water retention and swollen ankles.
In retrospect, I think the NDT has been causing me to have side effects, whereas I successfully took NDT from the same pharmacy at the same dosage for many years with very consistent lab results on that dosage. I don’t think NDT itself is the problem but rather how it’s not being manufactured properly or with high enough quality standards. The inspection of the China manufacturer in question was in around Oct. 2017. In May was around the time my symptoms started and around the time Women’s International changed their suppliers, possibly to the questionable manufacturer in China. It sounds like they don’t actually buy from the company in China, but that there are at least 1 or 2 middlemen between them and the company in China.
I will see how it goes and if the symptoms that I thought were being caused by something else actually clear up, and if so, I don’t see what else was causing them than the NDT. I’m very unhappy about that. But the first night of being on synthetic, the very first night, I had no insomnia. I’ve had insomnia every night or almost every night since May. I’d never had insomnia. And also practically immediately, I’m not feeling severely hot and sweaty almost all the time either.
In retrospect I’ve had many mysterious and troubling symptoms in recent months and even since last year. I’m really getting troubled more and more about those manufacturers in China and also how NDT is now being produced, who is producing it, and where it is being produced. If all those symptoms that I’ve been having clear up, and it’s interesting that at least 2 big symptoms have cleared up almost immediately after stopping NDT, I am really going to be upset but relieved at the same time.
Maybe the Women’s Intl and Westminster recalls somehow tie in with what’s going on with Nature-Throid and the problems people are facing with that. Maybe all those companies are getting their NDT from the same sources that have decreased in quality. If I’m not mistaken, the recalls being faced by compounding pharmacies like Women’s Intl and by Westminster stem back to the same company in China.
Also, I understand that there is a nationwide shortage of NDT at compounding pharmacies, and I don’t know if that means that no compounding pharmacies can get NDT. I called about 3 in different parts of the U.S. last week (not including Women’s Intl) and none of them have or can get NDT. I’m wondering if the NDT they are all getting is from China and specifically that one company.
It’s ridiculous how stressful and time-consuming this is. And it’s going to be very expensive too. Already the medication I had to switch to is more expensive than what I’ve been taking, and it’s a major hassle because it has to be refrigerated. And I’m going to have to have additional expensive doctor bills and labwork because of the recall.
Mary Lash
Have there been any recent reports on the effectiveness of the NDT various formulations from Thailand? Would it be a reasonable alternative? How does one know where the best place to order on the internet?
Janie Bowthorpe
Lots of people report liking it over the years. Someone can email you with the source they like. 🙂
Alex
Hello Janie, can I please get an email about Thai NDT too? I can’t find a pharmacy where I could buy it. Thank you!
MsH
have heard there is a pork powder recall ? anyone else?
Janie Bowthorpe
No, it’s simply the recall of the powder Westminster was using.
MsH
thanks i wonder why moments international has no other source. I am so tired of this. WP was all that worked well for me and now women’s intl cant make my compound
Beth
This is really getting out of hand. Mold toxicity has caused my hypothyroidism, and I will most likely be on meds for life. The last thing I need is to worry that I don’t have a reliable and consistent source. I was always suspicious of the alternatives once PCCA let me down – they were the best when their porcine powder was available. Since switching to an alternative compound, I have been miserable, and low and behold, I just found out it’s part of the recall! I knew I wasn’t crazy.
I feel like a jerk for ordering Naturethroid now that I hear all this negative feedback, but there is good news. I still have a bottle of Erfa, so I took my usual dose and WOW what a difference. I think I’ll use the Naturethroid as a back up in case Erfa “goodness forbid” goes under too.
I’ve also been tempted to try Medisca’s thyroid in the future. Homptinkon Drug in MA supplies it. If anyone has already tried it please give some feedback! Otherwise, now you have an alternative. You’re welcome.
Janie Bowthorpe
I found out just over a year ago that my hypo was mostly likely due to the immense levels of mold in the house I lived in when I got hypo. So I understand. Please know that NP Thyroid has been an excellent NDT product, and from talking to them, they probably won’t have shortages at all, or any changes to their product.
Anne
Janie, scary news about swine flu in China and Korea. Will this affect porcine thyroid? Do you know where Acella NP sources its thyroid? I have read that many medications sold in the US are from China. Are we in for a shortage? Thank you for your insight.
Judy
Wow, hadn’t heard about swine flu recently! The Women’s International and Westminster NDT that was recalled is from China! I never knew I was taking a product with a raw material from China. I haven’t read over the entire several-pages-long FDA documents, but in glancing at it, it sounds like the company in China has not been conscientious about cleanliness or quality. I’m not going to want to use a raw material like that again. I always assumed the raw material was coming from the U.S. or somewhere nearby with strict quality standards. A compounding pharmacist told me today that something like 90% of their chemicals are made in China, and that has to do with countries like China and India not having as strict standards as the U.S. when it comes to issues like the EPA. Also the materials can be made cheaply in those countries. Isn’t that lovely! This is really making me hesitant to use any NDT again, which is sad because I’ve been using it for years. I wonder what source NP uses for their raw material and if they have a cleaner, more upstanding source. I have had a lot of hair loss and insomnia and other symptoms in the past few months, and I wonder if that has to do with the NDT being subpar. Why does it always have to be such a grueling ordeal just to get a simple medication that we need for daily use?
Janie Bowthorpe
Judy, Acella won’t reveal it’s source–that’s considered private business information, but I know directly from them that it’s a source in the US and specifically for Acella.
Bridget
Hi Judy,
I am currently going through the same thing. Just got off the phone with Women’s I. Pharmacy and at a complete loss as to what to do now! I just started on this new medicine two months agai and feeling great. I have been on armour and Naturethroid previously, both of which made me very ill. Do I go synthetic? It is appalling that we have to outsource our porcine supply. The pharmacist was reluctant to provided a full refund, but after making a plea, said she would.
Waiting to hear back from my doctor regarding future prescriptions.
Be well,
Bridget
Marty
I was also upset reading about the many issues associated with this particular recall. I never had a problem with the previous supplier for WIP, but was told they could no longer get the NDT from that supplier. What was wied is that I called WIP in June when I received my refill perscribtion, and I developed some digestive issues, that was when I found out it was a different supplier. Hmm, I wonder if I was having a reaction then. The digestive issues have never really settled down. I just thought I was having a harder year.
Yvonne
Erfa is affected too at this point. I was unable to get 60mg, however they did substitute with 30mg.
I would suspect that will be unavailable soon . They expect the shortage to last until 3/2019.
Elizabeth S.
I have also been on compounded NDT for many years after going through synthetic, Armour, Nature-Throid, etc. Compounded solved ALL of my problems. Now there is a nationwide shortage of porcine powder, I am told, and neither of my local compounding pharmacies can get it. And I am located in North Carolina, the home of a huge pig industry! I am back on Armour. I don’t seem to do as well on it. My compounding pharmacy says they are now dispensing compounded synthetic in the same ratio with no fillers. I might try it. I just don’t understand the holdup. I am tired all the time now, dry eyes, constipated, foggy…
Yvette
Has Armour been reformulated recently? Like this year?
Janie Bowthorpe
Doesn’t appear so.
Michele
I was on WP and loved it. I felt wonderful. Now I”m chubby again with dry brittle hair on Nature-throid and cytomel. My TSH is always suppressed for my FREE T’s to be even on low normal, but my Ferritin is very low and I JUST found out my iodine levels are really low. Maybe that is why I feel so many Hashimoto symptoms including fibrocystic breasts? Takes forever to figure this stuff out. :/
Janie Bowthorpe
Hi Michele. Remember it’s not just about the ferritin, nor do we treat the ferritin. It’s about all four iron labs, and you treat the serum iron…and the low ferritin will follow in improvement. Why all four? Because some have found themselves with low ferritin and good or high iron! See https://stopthethyroidmadness.com/iron Yes, low iodine has been shown to aggravate problems. Hopefully you can also move over the one like NP Thyroid. Naturethroid seems to be a dud.
Alicia
My doctor switched me today to Nature-Throid 1 3/4 grain. I was on Armour, 2 grains is too much and 1 1/2 grain (90) even at 8 times a week was not enough. Armour does not make a 1 3/4 grain dose. How concerned should I be? I thought that finally I might get some relief. For the past couple of years I have been going back and forth from hypo and hyper states every 3 months. What do you recommend I should do? I’m getting labs done again in about 6 weeks.
Janie Bowthorpe
By saying that two grains was too much and 1 1/2 was not…are you allowing your doctor to dose you by the TSH?? Bigggg mistake. It’s about the free’s, not the TSH.
Also, if you get hyper, that can point to having an adrenal problem. And you might have low iron. See this: https://stopthethyroidmadness.com/ndt-doesnt-work-for-me
With all we know from patient reports, you might want to be on NP Thyroid, not Naturethroid right now. But it’s going to be super important that you look at your iron (all four iron labs) and cortisol (saliva, not blood). Then compare each to this page: https://stopthethyroidmadness.com/lab-values
Dorothy
Good to know this. I have been feeling so poorly for past few months. Fatigued. Hate everyone/everything. (I am on 2 grains of Naturethroid.)
Paula Haggart
I have recently switched from Armour to .Naturethroid. For me it is not working as well. Armour was a lot more expensive and did not have the right mg so I was taking 2 pills to get the correct dosage. My doctor wants blood work done before he ups my dose. Armour made me more out of breath and also had constipation issues. With Naturthroid my mood is not good and I am irritable. I am hoping a higher dosage can help with this. Any advice?
Janie Bowthorpe
It wasn’t Armour directly that made you out of breath and constipation. It can mean you were seriously underdosing yourself. Optimal puts our free T3 towards the top part of the range with a mid-range free T4. Both.
Richard Ellis
I’ve noticed that references to “optimal” values vary across some of your pages. Your optimal lab values page, as I read it, says optimal FT3 is “above mid-range.” Here you state “top part of the range.”
Ok…I’m an engineer. For me:
– above mid range = 50-100%
– top part of the range = 75-100%
BTW…STTM isn’t the only place I see this, and the recommendation vary also.
Janie Bowthorpe
Richard, I think you misread it. Here’s what we have based on years of observations and experiences. I have bolded what’s important to see:
a) Those without a thyroid problem have this above mid-range. The except is if the free T3 is above mid-range, and the free T4 is low in the range—the latter can point to a thyroid problem, we’ve noticed.
b) Those who are optimal on NDT will tend to have a free T3 towards the top top part of the range, ALONG WITH a mid-range free T4, patients have repeatedly noticed and reported. Lower and it backfires.
c) Those who are optimal T3-only notice a free T3 at the top if not slightly over
Note that it’s only those who don’t have a thyroid problem that we notice it’s “above mid-range”. Then for b) you’ll see that for those who are optimal on NDT, it’s toward the top part. And for c) those who are optimal on T3-only find it at the top if not slightly over.
The only variance is between those who have no thyroid problem, vs those on NDT, vs those on T3.
Alex
I am at loss!!! I don’t trust what FDA says!!
I just ordered Westminster…. What shall I do now? I only can say – STOP THE THYROID MADNESS!!! We do need working NDTs!!! But obviously FDA do not want it. I am at loss…
Paige
I agree. The FDA does not seem trustworthy. My compounding pharmacy tested their batch and found NO problem but it forced to wait until another option for NDT becomes available ARGHHHH
Judy
Yes, my compounding pharmacy said they do their own testing and had found that the potency of the raw material was correct. But they still had to not use and “quarantine” all the thyroid powder they had. Also, a few months ago the raw material they were getting had changed in appearance and texture. I wonder why? So many aspects to what’s been going in recent months that are very odd and mysterious. It was right around the time their raw material changed a few months ago that I started getting bad insomnia (which I never get and still have), hair loss, a bad infection, etc.
RITA LOSEE
After having my life wiped out by the Amrour escapade of 2009, I have been on compounded replacement — until Dec., 2017 when my phramacist told me he couldn’t supply me because their supplier had notified them they were no longer shipping. I have periodically re-checked with him to see if I could re-start compounded; they still can’t produce it. They are looking for another supplier. Crazy stuff!
Judy
Yes, I well remember the Armour and Nature-Throid fiascos of 2009. I’d been taking NT for years and it suddenly without warning became unavailable. Through trial and error and months of sickness, I wound up on compounded NDT and have been taking it since then, until the sudden recall that I just found out about yesterday. Thyroid care in the U.S. really is in the Dark Ages.
Jennifer Sand
Thanks once again Janie for a thorough treatment of what’s happening in the crazy world of desiccated thyroid. I’d like to say here that if you’ve been running around trying to find desiccated products, like I have, that Women’s International Pharmacy (easily located on Google) carries the desiccated thyroids like NP Acella, Naturethroid, Armour, or they will compound whatever dose you desire of T4 and/or T3 or desiccated thyroid in just olive oil in capsules. Of course, you’ll have to pay for the service. They have excellent customer service and everything is done by mail/fax/phone. Special request: would you consider, on your web page of all the NDTs, color-coding the ones that lend themselves to being taken sublingually? That’d be cool.
Christina
Women’s International Pharmacy has stopped making desiccated thyroid in olive oil as it’s been recalled too! Ugh!
Lynn
If you take T3 only, is the goal still the same: “a free T3 towards the top part of the range, and a free T4 midrange”?
Janie Bowthorpe
Only the free T3 and some say they keep theirs slightly over the top on T3-only. On T3-only, you will naturally have quite a low free T4.
andrea booth
FYI there was a press release today about quality issues for thyroid medication .. https://www.medscape.com/viewarticle/900606?nlid=124357_4562&src=wnl_dne_180814_mscpedit&uac=244745CY&impID=1711707&faf=1
Here is the first paragraph if you cannot access MedScape .. Westminster Pharmaceuticals has recalled all unexpired lots of levothyroxine and liothyronine (thyroid tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, and 120 mg to the wholesale level, according to a company notice posted on the US Food and Drug Administration (FDA) website. The recall is a precautionary measure because the products were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s import alert regarding Sichuan Friendly Pharmaceutical company in China.
The alert follows a 2017 FDA inspection that found “significant deviations” from current good manufacturing practices for active pharmaceutical ingredients that could represent the possibility of risk being introduced into the manufacturing process, the FDA said.
Thyroid contains both tetraiodothyronine sodium (T4 levothyroxine) and liothyronine sodium (T3 liothyronine) and is a natural preparation derived from porcine thyroid glands for oral use as replacement or supplemental therapy in patients with hypothyroidism.
Patients are advised to continue taking the recalled medicines until they have a replacement product. To date, Westminster Pharmaceuticals has not received any reports of adverse events related to the products. The recalled products are packed in 100-count bottles. National drug codes, descriptions, as well as the 38 lot numbers and expiration dates for the products are available on the FDA website.
https://static1.squarespace.com/static/58ff6d422e69cf8f337deb5d/t/5b6e330c758d460188a89e5c/1533948685692/Press+Release+-+Thyroid+Recall.pdf
Janie Bowthorpe
Yes, that information comes from the original FDA press release a few days before this Medscape article came about and is mentioned in the article as well. It’s only about Westminster’s version of NDT.
Jane Woods
Nice post!
Andrea
I agree it has been a crazy, unhealthy time for those of us on NDT. I moved to Armour from T4 . gsGreat results! Then things deteriorated. So I finally got NatureThyroid, after the long shortage. And now I am full on hypothyroid! It’s been dreadful. I am trying to get a new Rx for NP Thyroid, but now my Dr. is hesitant. 🙁 So I am really struggling, I will go back to Armour if necessary. Hope things get better.
Jane Woods
Nice!