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Tag: nth

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

The FDA has spoken

fdaimage

This post was originally written in 2009–interesting that nothing has changed since then. 

Just spoke with a thyroid patient who spoke with Lena Choe of the FDA. She is a pharmacist in the Division of Drug Information at the FDA.

Choe stated that they are not taking current action with Forest Labs and RLC Labs in regards to Armour and Naturethroid. Instead, they will simply be requiring them to go through the New Drug Application process, and they will require data. Data is possibly referring to the clinical trials that both companies will have to perform to get results on the efficacy and safety of desiccated thyroid.

Choe stated that the FDA is very aware of problems with Armour and will be looking into that eventually. The FDA takes priority actions on medications based on consumer complaints.

A comment which I found hopeful from Choe was her knowledge that desiccated thyroid has already been use in humans since the 1962 amendment. That’s a good track record of 47 years, folks, that the FDA is referring to. Of course, many of us also know that NDT had a good track record since the 1890’s.

1962 represents the year the FDA established the “Drug Efficacy Amendment”, also called the Kefauver Harris Amendment. The amendment requires that pharmaceutical drug manufacturers provide proof of the effectiveness and safety of their drugs before they can receive FDA approval, aka clinical trials and the data that results. The amendment also requires accurate marketing information on side effects (think Bob and erectile dysfunction on those irritating, nauseating commercials).

And again, it still appears as I stated below that both Major and Time Caps were told to cease production due to being “new” companies since 1962 producing desiccated thyroid. That is a different issue than RLC and Forest.

Hang onto hope, folks. Because by the limited information everyone gets when they call the FDA, it points to a good reason to feel positive, not to think the worst…at least for me. Sure, it’s maddening they would shut down whatever production was left of desiccated thyroid. And it’s equally frustrating that we hang by threads as far as FDA communication. But right now, as I also thought a few days ago, I don’t think the FDA is shutting down production of RLC and Forest, or will during the NDA process. We just have to wait for supply to catch up, especially with RLC. So we’ll see what passes.

33 replies