Another interesting reply to a patient by the FDA

fdaimageAs thyroid patients are not only in angst about a complete shortage of desiccated thyroid in the US, we all have questions and concerns about out future with no definitive answer.

For example, we wonder if the FDA may be  requiring clinical studies from pharmaceuticals who make desiccated thyroid to prove that it’s safe and effective (in spite of the fact that patients have been using it safely and effectively for 110 years.  Nope, we don’t count. Amazing, isn’t it?) And we wonder: if studies are required, will they be able to afford the studies, which are quite expensive? Will desiccated thyroid continue to be available while the studies go on? And more uncomfortable questions.

The FDA recently replied to a question by thyroid patient Catherine when she asked about the shortages and here’s their reply:

Dear Catherine:

Thank you for writing the Division of Drug Information, in the FDA’s Center for Drug Evaluation and Research.

We understand your concerns regarding the availability of natural desiccated thyroid products.  FDA has NOT taken class action against unapproved thyroid products resulting in a shortage.  If a company discontinues manufacturing of an unapproved product, that is a business decision made by the company.

Please refer to the ASHP Shortages website for a listing of desiccated thyroid products that remain available:
http://www.ashp.org/Import/PRACTICEANDPOLICY/PracticeResourceCenters/DrugShortages/GettingStarted/CurrentShortages/Bulletin.aspx?id=459

We have contacted the companies and RLC (manufacturer of West-Throid and Nature-Throid) is in backorder for all strengths and products for the next 90 days.

Major has the 60mg and 120mg available of their “generic” desiccated thyroid product.  They report increased demand as the reason for their backorder for the other strengths.

Forest reports they have the 120mg, 240mg, and 300mg strengths available for their Armour Thyroid products and they report increased demand as the reason for the backorder on their other strengths.

If you and your healthcare provider determine that one of these thyroid products is appropriate for you, you can provide the NDC numbers listed on the ASHP website for these products to your pharmacist so they can order for you.

Best regards,
Drug Information SH
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

The interesting thing about the above is that it implies that Major Pharmaceuticals is just on backorder, which goes completely against what patients have reported elsewhere.  What’s going on there? Are they using old knowledge? And the larger sizes of Armour? Is anyone finding that at the pharmacies right now? Very curious. Interesting the comment about RLC, the makers of Naturethroid.  And the link to shortages is interesting, though from the end of July.

Whatever the answers are, if you need a treatment to get you through this difficult time, here are options for thyroid treatment. And it still may be a very good idea to inform your congresspersons of our situation…just in case. See my blog post below.

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10 Responses to “Another interesting reply to a patient by the FDA”

  1. Michelle

    I spoke with Lisa today and she used the word unapproved numerous times. She said they COULD but haven’t taken action against desiccated thyroid. I asked why they possibly might take action against these wonderful and patient proven products and she said that since 1997, they have started to require all unapproved drugs to get approval. Again, I asked – why right now, if this has been a possibility for 11 years. Her reply was that they haven’t yet required such approval but they could. The only positive she said is that there is another process whereby the natural thyroid companies could apply for approval with literature OR a clinical trial. In that literature, they can provide data that isn’t necessarily their own. She didn’t elaborate. I asked if any of this new attention has to do with complaints of the new Armour not working well. She said no. I asked why there is a nationwide shortage at this moment and she said that there is likely a shortage on desiccated thyroid because they are not drugs that are approved by the FDA. I was trying not to get caught up in the hype but that last sentence bothered me big time.

    Reply
  2. Michelle

    I neglected to state that Lisa was calling me back from a message I left her last week when all sources said to call the FDA. It is not my impression that additional calls would help or that they would glean additional information.

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  3. Me

    “….she said that there is likely a shor­tage on desic­ca­ted thy­roid because they are not drugs that are appro­ved by the FDA.”

    Oh, my gosh, right. There’s a shortage because it’s not approved. What the heck kind of nonsense is that. Talk about double talk and pure guessing on her part. That doesn’t seem like a response from someone with a brain.

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  4. Judy J.

    I went to Walgreens at 1st and Patterson yesterday and they said they could get desiccated thyroid from their suppliers. The exception is Armour and it appears Forest Labs are playing games with supply and demand for pharmacies. They don’t care too much since they have enough desiccated thyroid from Major and other sources. I got the feeling the other generic sources were Canadian.
    Do you think they are playing silly little games? I do. I did write my senators and Representatives and asked them to look into the situation. Maybe they will.

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  5. Linda

    @Judy: I didn’t know that U.S. pharmacies could order product from Canada. Since the FDA shut down generics here, would they allow Erfa to be sold? If so, I wonder why more pharmacies don’t just order Erfa. I’m going to ask my pharmacy about that.

    Re Armour in certain sizes: my Walgreen’s spent 2 weeks trying to scrounge up either Nature-throid or Armour for me and finally came up with a month’s worth of the 120 mg size of Armour. I was surprised they were able to do that, since everyone else in town was telling me they were totally out of everything.

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  6. Rob Marks

    Wow, am I confused!

    What I’ve read initially was that the FDA has halted domestic production of all Armour thyroid or desiccated thyroid because it wants producers to go through the process of running tests and producing data to show the efficacy and safety of these products despite the fact that they have been in use for more than 40 years and were believed grandfathered.

    Separately, the FDA or the EPA has halted production of the sole source of raw material at Americn Laboratories, Inc. in Omaha, Nebraska.

    Now, I’m reading messages on this bulletin board that quote the FDA as saying that they are not halting production and the suggestion by those posting that Forest Labs is playing games with the issue.

    What’s the facts?

    (From Janie: right now there’s so much speculation that it’s muddying things up. 🙁 Sorry about your confusion. This is why I am calling for all of us to stick to facts, and be careful with speculation. Your second paragraph…I have not heard. It’s a mess, isn’t it!)

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  7. Colleen Coble

    I have no trouble getting Armour from Walgreens but they can’t get me Naturethroid for 90 days. I’m going to try the compounding pharmacy that makes my bioidentical hormones today and see what they tell me. They’ll know more about what’s going on. Armour wasn’t working as well so I asked my doctor to switch me to Naturethroid and discovered their shortage. They told Walgreens they’d had a huge upswing in orders and couldn’t keep up with demand. I think that’s likely because of websites like this where we talk about the problems and what we’ve tried that works better. They told Walgreens they have very high demands for quality and it will take that long to get enough supply that matches their high standards.

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  8. Kim

    When I called Walgreens (in San Francisco, 3 stores) last week, they had *just* received 2 grain tablets of Armour, but had no Naturethroid. I got the last 135 1 grain tablets.

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  9. Millie

    I just went to pick up my mom’s armour thyroid at Target this evening where I have had no trouble getting it in the past. I was told it is on backorder indefinitely, they were only able to give me 40 out of 60 pills ordered for 30 days, and they couldn’t tell me when they would get it in.

    Reply
  10. Liz

    Why doesnt the FDA go after the cigarette companies that are killing millions with their poison If they are so damn concerned about people. Leave our natural thyroid meds alone.
    What I find funny is that they can prescribe marijuana in Cali, to anyone who can get a prescription, but thyroid patients cant get something thats been around 100+ years and makes them feel good too?
    Oh and I’m curious? How do you regulate pot? How can you be sure of it’s consistency too? How by smoking it?

    Enough of this B.S.

    Put a damn warning label on my pill bottle if you must and give me my damn meds already.

    Reply

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