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All about Drug Recalls and what happened to Westminster’s Natural Desiccated Thyroid

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

99 replies

UH OH–Naturethroid and WP Thyroid Shortages and what to do

NOTE: this post starts with what was going on in September 2017, and there are updates to it at the bottom of the article. If you didn’t know about this, you need to sign up for blog post notifications at the bottom right of the STTM website.

UPDATE: since the new Naturethroid has come out in 2018, there have been an awful lot of patients reports in seeing their hypothyroidism return, with labs to prove it. It has not been pretty.

Feeling panicked or frustrated by the shortages of two particular brands of Natural Desiccated Thyroid? Let’s take a look at all of this and what you can do.

Brands of NDT

Nature-Throid® and WP Thyroid® are two brands of NDT produced by the U.S. pharmaceutical RLC Labs. (There’s even an older third brand occasionally still foundable: Westhroid, which is said to be exactly the same as Naturethroid, though in less strengths than Naturethroid provides.)

As mentioned in the most sought-after patient-to-patient hypothyroid book on the market, RLC (formerly Western Research) has been around a long time–since the early 1930’s. And it appears they aren’t about to end that long tradition of their existence.

Why the shortage

RLC explains that the shortages are due to “significant upgrades to our facility and equipment”. And though that has created great inconveniences to and frustrations by users of their products, it’s clearly stated by RLC to be a temporary issue, though the resolution may take awhile.

Steps to consider in the meantime

  1. Writing the prescription differently First, make sure you doctor writes your prescription in a way that you are able to get any other brand of NDT your favorite pharmacy provides. One way is for him to write simply “desiccated thyroid”, then the amount you use, instead of mentioning a brand.
  2. Call around to different pharmacies. Patients are reporting that some still have their supplies of Naturethroid or WP, and especially WP. See if that makes you lucky.
  3. Consider other NDT brands. For example, NP Thyroid by Acella has been proven by patients to be a solid and well-made Natural Desiccated Thyroid, similar to the old version of Armour. And there are no shortages of NP.
  4. Compounding pharmacies Though more expensive, these versions of pharmacies are a way to have your NDT made according to you or your doctor’s specifications, especially fillers used.
  5. Using synthetic T3 with synthetic T4 If the two synthetics are used, patients have learned that their goals end up being the same as Natural Desiccated Thyroid as far as lab results with the free T3 and free T4, plus removal of symptoms, as well as not going by the TSH lab test. To see different brands of synthetic T3 like Cytomel and others, go here and see them in pink.

Why a pharmaceutical might be doing an upgrade

The U.S. Food and Drug Administration (FDA) states they inspect pharmaceutical manufacturing facilities worldwide, based on standards outlined by the Current Good Manufacturing Practice (CGMPs) regulations. This is especially true for those facilities which manufacture active ingredients like “thyroid tissue”, as well as the finished pill or liquid product from the contained ingredients. They state “inspections follow a standard approach and are conducted by highly trained FDA staff.” 1

Says the FDA:

CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.2

If you really want to get detailed information on CGMPs, here you go: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064971.htm

Stop the Thyroid Madness has not seen anything stated from RLC that this is the reason for the upgrades causing the shortages. But it will be interesting to see what the Naturethroid and WP Thyroid tablets look like, and act like, after this upgrade and catchup.

UPDATE as of OCTOBER 10th, 2017:

Heard the following from a gal who called RLC Labs: They have been working on the one grain tablets, and stated they should be finished in about two weeks. Then they will be mass shipping to pharmacies after that time around the first of November.

UPDATE as of November 2nd, 2017

From RLC Labs:

We are happy to announce that Nature-Throid 1 grain (65 mg) is shipping! Shipping for this strength began a few weeks ago and it should be hitting pharmacy shelves soon, but that can be variable; some locations may even already have it stocked and available. If your usual pharmacy is unable to fill your prescription, we recommend contacting other local pharmacies to see what they have in stock. You can also try any of the mail-order pharmacies listed on our website for a potentially faster turnaround. Strengths are being prioritized based on highest demand, starting with Nature-Throid 1 grain, and we are releasing in all counts. The next strength to be released will be Nature-Throid ½ grain (32.5 mg), and we will post here when it starts shipping. We are unable to provide any updates around WP Thyroid at this time, but will share them and any other new details on this page as soon as they are available. Every effort is being made to have all strengths stocked and available as quickly as possible while still maintaining our strict quality standards—the industry allows for a monograph discrepancy of +/-10% between T4 and T3, but WP Thyroid and Nature-Throid are not released outside of +/-2%. Patients are and always have been the top priority at RLC Labs, and we are literally working day and night to get back to our usual pace as quickly as possible. Your understanding and continued support are greatly appreciated as we do our best to get back to our usual pace. *Please discuss all health-related questions or concerns, including those about symptoms, with your physician.

UPDATE as of January 15, 2018

https://getrealthyroid.com/product-availability.html

In the meantime, NP Thyroid by Acella is a good one to switch to. You may have to adjust it for your own needs.

MORE INFORMATION:

  • Can Hashimoto’s patients do well on Natural Desiccated Thyroid? Find out here.
  • Is it true that thyroid cancer patients should avoid NDT? See this.
  • How do I use Natural Desiccated Thyroid? See what patients have learned here.
  • What if I want to use synthetic T3 instead? See this.
  • Where do I get the Stop the Thyroid Madness books I hear so much about? Right here.

 

 

1. https://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm169105.htm
2. https://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm169105.htm
663 replies

Washington spits in your face, anti-depressant problem, and the STTM book is now in German and Swedish!

The US Government is going to confiscate your meds sent from overseas!

Fall is in the US, but as you were enjoying your summer, it happened in a flash:  last July, President Obama signed into law the FDA Safety and Innovation Act (S. 3187). And that Act includes a section that might negatively affect your life as a thyroid patient if you are among those feel forced to get your life-saving natural desiccated thyroid (NDT) or related medications from overseas (because your doctor was too clueless to either prescribe NDT or give you enough thanks to the medical stupidity about the TSH lab test).

i.e. in Section 708, the US government now has the authority to destroy a package of personally imported drugs at their point of entry to the United States…even if you badly need them. And this potentially includes NDT like Erfa coming to us from safe, reputable Canadian online pharmacies by prescription! Or your T3-only from other places. Both the latter are unclear, but it’s a possibility.

And do you know why they state they are doing this?? For your “SAFETY”.  Janie’s eyes rolling here.  Can someone tell me how they know if a thyroid med from somewhere else is “unsafe” simply because it wasn’t made in the US?? Are US-made drugs SAFE??? Give me a break. Ask that of folks whose lives paid big prices because of side effects from our FDA-approved medications like Synthroid and many other NON-thyroid related drugs pushed upon us. It’s all a bunch of Big Pharma-influenced, greedy hooey, say thyroid patients.

Now as far as we know, this isn’t going to affect anything really soon. The US Secretary of Health and Human Services has up to two years to decide how to make the new law a reality. But it may happen far sooner than later in that time frame and I would count on it.

Says Lee Graczyk, RxRights Lead Organizer, “It’s critical for people to stand up and get organized to fight against this harmful regulation!”

Anti-depressant use and your adrenals: not a helpful connection for some

Sure, having depression is not fun and it’s understandable if you want to do something about it. My own mother had depression so bad thanks to her lifelong use of Synthroid that she used anti-depressants her entire adult life. This was long before we, as thyroid patients, discovered the strong connection between low T3 levels in the brain and depression (and a connection which all too many doctors miss!)

She also had an extremely “emotionally apathetic” personality, which I assumed was solely due to the electric shock treatment she had while in her early 40’s in an attempt to reverse the depression. But turns out her impassive and flat personality could have also been from the nasty side-effects of my mother’s long-term antidepressant use. i.e. while they made her “happy”, they also made her more dull, flat and detached. This has been reported by all-too-many patients

But now we are seeing the problems that anti-depressant use can cause for your adrenals. A study done in September 2011 titled Antidepressant use and salivary cortisol in depressive and anxiety disorders reveals that

  1. Tricyclics* flatten your cortisol awakening response
  2. SSRI users** had higher evening cortisol levels
  3. Most antidepressants are associated with distinct alterations of the HPA axis (hypothalamus, pituitary and adrenal feedback loop)

*A common form of Tricyclics is Elavil (Amitriptyline).  **Common examples of SSRI antidepressant (Selective serotonin re-uptake inhibitors or serotonin-specific reuptake inhibitor) include Lexapro, Prozac, Celexa, Paxil, Zoloft, etc) 

The alternation of your HPA axis is a common finding when you peruse several research studies. And it’s even more obvious when thyroid patients with adrenal fatigue start using the T3 Circadian Method. i.e. it can take longer to get the right response from the T3. ***Please note that this is simply providing information in the name of being informed patients, not a recommendation to get off your antidepressant!  Talk to your doctor.

(Speaking of mood issues, a study was done showing cherries help with mood. Who would’ve guessed. You can read about it here.)

The revised Stop the Thyroid Madness book is now in German and Swedish! 

You can read about the translations here and I included an autobiography of each translator!  Please do not comment asking if a particular language is coming. I’ll announce them when the day comes.  If you know someone in Germany or Sweden who could badly use the patient-to-patient information in this book, go here.

4 replies

The pitiful challenges even a Good Doctor faces….ignorance, stupidity, resistance. Read this!

(Reading this via email notification?  Remember to leave a comment RIGHT on the blog post by clicking on the title of this blog post in your email.)

As thyroid patients, we are continually seeking doctors who understand successful patient experience. It’s not always easy.  So when we do find a good doctor, we’re ecstatic. But little do we know the challenges a good doctor faces!  The following was sent to me by a progressive, open-minded MD, of whose name I have removed to protect him from his own medical board. Be appalled and amazed. I was.

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Janie, it is not infrequent that we are sent messages like this from Pharmacy Benefits Managers. Here is a typical letter with my reply.

Considerations for Your Review

1. Drug Safety Consideration: ARMOUR THYROID Use in Seniors  Our claims record suggests that your older patient is receiving ARMOUR THYROID. Thyroid hormones should be dosed cautiously in seniors due to a potential risk of cardiac effects. Desiccated thyroid products contain variable amounts of T3. T4 and other iodothyronine compounds. Because older patients have a high prevalence of occult
cardiac disease, the Beers criteria generally recommend transition to a safer alternative (e.g.. agents like levothyroxine with more standardized hormone content). Please consider the potential risks versus benefits of therapy for your patient.

Reference(s):
1. Thyroid Agents. In: McEvoy GK, ed. AHFS: Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2008:Sec 68:36.04.
2. Pick DM et al. Updating the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Archives of Internal Medicine. 2003; 163:2716-2724.
3. Semla TP et al. Geriatric Dosage Handbook. 13th ed. Hudson, OH: Lexi-Comp; 2007.

(And this brilliant doctor’s reply:)

Dear  xxxxxxx

Re: Armour Thyroid Products

I invite your attention to the P.I. (product information) in the PDR on levothyroxine (Synthroid). I quote:  PRECAUTIONS “Patients with underlying cardiovascular disease–Exercise caution when administering levothyroxine to patients with cardiovascular disorders and to the elderly in whom there is an increased risk of occult cardiac disease.”

DOSAGE AND ADMINISTRATION

“Caution should be exercised when administering SYNTHROID to patients with underlying cardiovascular disease, to the elderly, and to those with concomitant adrenal insufficiency (see PRECAUTIONS).”

I read your statement that says, “Desiccated thyroid products contain variable amounts of T3 and T4 and other idothyronine compounds.”  Forest Pharmaceuticals has stated their product is standardized as published in the PDR: “ One (1) grain or 60 mg of Armour contains by assay 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3).” I do not ever remember Armour Thyroid ever being recalled for stability or lack of standardization.

However, Synthroid and the other forms of levothyroxine have had significant problems.

SYNTHROID AND OTHER T4 PRODUCTS were subject to FDA NOTICE in the FEDERAL REGISTER: AUGUST 14, 1997 (VOL 62, NUMBER 157). These were the drugs that were not well standardized and were not stable. I quote from the report: “Some of the problems reported were the result of switching brands. However, other adverse events occurred when patients received a refill of a product on which they had been previously stable, indicating a lack of consistency in stability, potency, and bioavailability between different lots of tablets from the same manufacturer.”

Thank you for caring for the health of the patients receiving medications from your company. I request that you check your facts fully before issuing such flyers.

Respectfully,

xxxxxxxxx, M.D.

Cc: FOREST PHARMACEUTICALS

BRAVO TO THIS DOCTOR in the face of complete ignorance!!

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STTM HAS HIRED A PUBLICIST and YOUR HELP IS NEEDED!

Do you value what Stop the Thyroid Madness has given you??  Something has to be done to reach millions of individuals still lingering without a diagnosis due to the TSH, or suffering due to being on T4-only meds! You and I run into them DAILY and don’t even know it!  Or we have many family members in the TSH/T4 category. And the media does NOTHING about this scandal.  STTM has hired a publicist, and you can read about it here. But I can’t do this alone. If you value Stop the Thyroid Madness, please considering helping.

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TPA (Thyroid Patient Advocacy) STILL NEEDS YOU TO REGISTER 

Have you registered for the Counterexamples to T4-only?  So far, 1437 have, and Sheila Turner is determined to get that number to over 2000 at least. There were 900 participants on those flawed studies showing that T4/T3 combination worked no better than T4-only, and we have got to prove our point that this is wrong.  All you have to do is answer 3 very short questions.  http://www.tpa-uk.org.uk/register_of_counterexamples.php

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10 replies

What does the production of a new generic desiccated thyroid by Acella mean??

Even tho I saw this mentioned by a patient here or there on patient groups, and later saw it mentioned elsewhere on the net, I have been very hesitant to talk about it on this very widely-read website called Stop the Thyroid Madness.

Namely, there is a new US-made natural desiccated thyroid product out there. It’s considered generic, and is being actively substituted for Armour when patients go to pick up their Armour at the pharmacy.  It’s made by Acella Pharmaceuticals LLC in Alpharetta, Georgia, which was formerly Brookstone Pharmaceuticals. And I just found out that the inactive ingredients are listed as calcium stearate, dextrose monohydrate, maltodextrin and mineral oil.  Anybody see cellulose in there?? Neither do I. Very nice.

It also contains the same T4/T3 amounts we are used to in the 60 mg, one grain tablet: 38/9. Oh, and it’s still called an “unapproved drug”.

Now before you get all ticked off at me for NOT wanting to talk about it here as it has been done elsewhere, understand this: last year, we saw the FDA shut down ALL generic production of desiccated thyroid. The implication was that ONLY ones around since the 1930’s (Armour and Naturethroid) were allowed to exist, being an unapproved drug.  So…I worried that by mentioning it, we might give TOO much attention to a new one and see THIS ONE shut down.

But right now, I am seeing information about it on certain medicine website, including this one connected to our government.

Don’t ya just love the way things happen with a medication that turns lives around and we know NOTHING as to whythey are happening or when from the FDA?? Pitiful, typical…and sad.

***If you want to talk about this new generic version, which some patients are accepting in place of Armour and trying, go to the NTH (Natural Thyroid Hormones) yahoo group here.  It’s so new that there’s not a lot of feedback yet from folks, but I suspect we’ll start to see more and more.

P.S. If you have been through any long-term stress, you need to know that your cortisol will go high to help you cope, and in turn, it can drive your potassium and magnesium levels low. That happened to me this year as I went through prolonged stress from the economy.  So be sure and get those tested, and specifically the RBC (red blood cell) rather than serum. The RBC tests will show what your cells have.

HAPPY NEW YEAR, 2011!

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As we enter another wonderful year, the Stop the Thyroid Madness website couldn’t exist without your donations to the hosting fees, which have grown substantially due to the popularity of this patient-to-patient informational website. If you have benefitted from STTM, please consider donating to the fees here.  And thank you, since your donation assures that other will benefit as you have.

47 replies