Comments on: Thyroid Tidbit: about shortages of desiccated thyroid

By: gina

gina — Mon, 08 Jun 2009 13:33:40 +0000

Monica, you might ask your PA the following question. If the “FDA has placed limits on Armour”, somehow limiting your dosage to “180 mg. per day”, then why is it available in single-tablet strengths up to 5 grains (300 mgs.)?

[Attn Janie: Monica's post appears twice.] (Thanks Gina.)

By: Monica "Teajunkie" Koziol

Monica "Teajunkie" Koziol — Sun, 07 Jun 2009 04:47:33 +0000

Since May 15, 2009 I had been calling for my Armour refill: 2-2 grain tabs plus one to two 1/2 grain tabs one to two times a day – I was given only one grain and was told to take it once a day. This was a huge mistake made by the doctor who oversees the work of the NPR and PA-C. Every other day the assistant to the Pa-C said she called in the corrected amount while claiming that “the pharmacy at Walgreen’s is a lower class of pharmacists who probably did not understand her “orders” for 90 and 30″ [60mg were unavailable, according to the pharmacists]. The pharmacy telephoned Forest Labs and it was confirmed that there was a “back-log” of orders. The PA-C told me that all this meant was that “Armour is an unpopular thyroid medicine” and not as useful as my claims since I am at 180mg. This indicated to me that they were unable to fill the many orders that were necessary for patients, this meant to me that more people were catching on – and of course she still did not understand its benefits even admitting she did not know how to dose Armour!

I am, finally, slowly getting back my life after being on Armour for almost a year, as opposed to being functionally hypothyroid with all of its insidious affects for many years! What is additionally taxing to my nervous system is that the PA-C who was administering Armour has now claimed that I am at my limit of 180 mg. per day. This she says is because the FDA has placed limits on Armour. I said: “Come on.” And she said: “I’m not going to argue with you” giving me only enough meds for two months. Of course I knew better but telephoned the FDA just to hear a rational explanation and maybe that I was right. Anyway, I spoke with Larry Lim who assures me that this is “false information” and that the FDA does not become involved with limiting physicians’ ability to treat their patients when it comes to Armour.

My thought is that the PA-C who said last June 19, 08, she would prescribe Armour for me, is now finding creative ways to discourage me from taking this highly valued medicine, bioidentical supplement and/or replacement therapy to which my body is just now becoming accustomed.

This, in my view is against the oath of “First, Do No Harm”; and I am again looking for a true care practitioner who understands this disease and knows how to treat it, and me!

By: Janie

Janie — Tue, 02 Jun 2009 01:04:48 +0000

The following is from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2007/ucm076574.htm:

The grandfather clauses have been construed very narrowly by the courts and drug products on the market would not be entitled to grandfather status if they differed from the previous version in some respect, such as formulation, dosage or strength, dosage form, route of administration, indications, or intended patient population. Only drugs that are, at a minimum, identical in formulation and conditions of use as their predecessor pre 1938 or 1962 drugs, can be grandfathered. For additional information concerning grandfather status, please see 21 C.F.R. § 314.200(e)(2) and the appendix of our Compliance Policy Guide Marketed Unapproved Drugs at http://www.fda.gov/cder/guidance/6911fnl.htm, lines 323-329.

Further, it is FDA’s view that companies claiming that their products are grandfathered bear responsibility to fully document their products’ grandfathered status. Any company marketing products on this basis should have available documentation to demonstrate the market presence of the product prior to the enactment of the new drug requirements that were established in 1938 and 1962.

From Janie: There are many articles on the net which refer to Armour as a grandfathered drug. There are some articles which say the opposite. But whatever the answer is, you can be assured that the makers of Armour and other desiccated thyroid products follow the United States Pharmacopeia (USP)’s Good
Manufacturing Practices for Drug Products and Excipients, which ensures quality and consistency from one bottle to the next, and “meets the label or certificate of analysis claims for identification, strength, purity, and quality.”

By: Courtney

Courtney — Mon, 01 Jun 2009 23:38:03 +0000

Why does the article state that these products aren’t FDA approved? My understanding is that they were grandfathered in because the treatment was already in place when the FDA started their testing/approval process. Are the large pharmaceutical companies using the FDA to force makers of dessicated thyroid out of business by requiring approval of what has been a grandfathered in product? It would make sense, since the cost of products like armour tend to be less expensive than the synthetic pharmaceuticals and the big pharmaceuticals can’t make money on a product that they can’t patent. Their new drugs aren’t making them as much money and dessicated thyroid is competition, so if you can’t compete with dessicated thyroid, get it elimated?