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Category: shortages of desiccated thyroid

FDA is not requiring form when you order Erfa’s Thyroid

CloudSilverLiningSometimes there is a silver lining with the storm cloud of backordered US desiccated thyroid.

Erfa, the makers of the Canadian version of natural desiccated thyroid, simply called “Thyroid”, has recently announced that the FDA is not requiring the extensive FDA Form 1572 from US citizens and their doctors when they fill their prescriptions from Erfa directly. i.e. it’s now a lot easier to get your prescription filled directly from them.

http://www.erfa-sa.com/thyroid_usa.htm

And those who have started to use Erfa’s Thyroid report being quite pleased. A cherry on top is that Thyroid has that old sweet taste we used to all like with the old Armour, and it can be done sublingually as well! You can see the ingredients here.

Also, I am continuing to get emails from patients that both Armour and Naturethroid is starting to appear on pharmacy shelves, even if in small quantities. I’m personally not too excited about Armour reappearing if Forest continues to make the reformulated version. Just too many patients reporting a return of hypo symptoms, even when they raise it, plus new symptoms of undertreatment and/or challenged adrenals thanks to the reformulated version. Sad. Oh how we will all miss the old Armour.

In the meantime, here are options for thyroid treatment we all have until we see a good return of desiccated thyroid, including Naturethroid and Westhroid. They are all far, far better than being on T4 alone like Synthroid, Levoxyl, levothyroxine, et al. You’ll also note compounded thyroid, which can be a good option, and you can read about on a recent blog post. Australians happily use compounded in their own country. Any option you and your doctor choose may mean a readjustment by your body, by the way.

Want to talk to other patients on how they are dealing with the shortages? Join the Coalition for Desiccated Thyroid. Or if you simply need patient feedback about your hypothyroidism, go to the Talk to Others page. Remember that no patient group is meant to be a substitute for your relationship with your doctor.

**The next Thyroid Patient Community Call will be held Thursday Oct. 8th on TalkShoe, and our topic will be iodine and your thyroid with patient expert Stephanie Buist. Come join us and listen right on your computer, or you can also talk live to Stephanie or Janie with your questions.

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Yes, desiccated thyroid is making its way to pharmacy shelves!

shortage

With all the panic among thyroid patients of the last several weeks, we are now seeing light at the end of the current tunnel of desiccated thyroid shortages. More reports are coming in by patients that it’s appearing on shelves at their local pharmacies, including both Armour and Naturethroid. Sure, it’s a trickle compared to the amount of US patients that need it. But it’s a sign of hope of more to come.

On the CDT (Coalition for Desiccated Thyroid) yahoo group, where patients have been discussing the shortages and finding places to get their desiccated thyroid, patient Elenor gave just one more example:

“After losing “my” Wal-Mart’s last left-over bottle of Naturethroid to some other thyroid person (lucky him or her){wink}, I called around to pharms — and Sam’s Club Pharm two towns over had just gotten ONE bottle of 60mg Armour in yesterday. (I did also find a CVS that had a bottle and a half of the 90mg Armour — so there are some dribs-and-drabs left around… My doc wouldn’t write for me to get that too…) (YAY!) Emailed my doc’s nurse begging her to do it right away — which thankfully she did, so they dispensed it “to me” and I can pick it up today! Down to three days left in my possession, so … WHEW!”

Elenor concluded: Still gonna see my doc 5th Oct and try to order 500 tablets from Canada. I do not EVER want to be scrambling like this again — for ANY reason…

And we all agree with you, Elenor!

Clearly, our current shortages were caused by two factors: demand being greater than supply thanks to websites like Stop the Thyroid Madness (STTM), forums, groups and others, as well as the remarkably poor timing by the FDA in causing the only remaining generic makers of desiccated thyroid to cease production.

And in case you haven’t caught up with what’s going on, you can read a summary of the history about the FDA and regulations which will explain what we will have to face for desiccated thyroid in the future, which is our real challenge.

**JOIN US TONIGHT for our weekly THYROID PATIENT COMMUNITY CALL hosted by Janie Bowthorpe. We’ll have an open topic night and perhaps a surprise guest (still waiting on confirmation on that). Let’s talk about the shortages, ways to continue treating during this time, and more. NOTE that I have moved up the times by one hour. Just click on the link and you’ll see a countdown of when it starts: 6 pm Pacific, 7 pm Mountain, 8 pm Central and 9 pm Eastern.

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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.

*Want to be informed of these blog posts? Curious what’s on Janie’s mind? Use the Notifications on the left below the links.

*STTM t-shirts are 50% off! I love sales.

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