Tag Archives: shortage

Behind the Disappearance of Armour Thyroid

After 50 years of exemplary therapeutic use and despite a large devoted following, Armour Thyroid and related dessicated thyroid generics have virtually disappeared from pharmacies in the U.S. An air of mystery with suggestions of conspiracy surround the shortage. The level of distress among Armour users confronted by their inability to obtain the medication, is extraordinary. Adding to the turmoil and confusion is the manufacturers’ continued reliance on flimsy and unconvincing explanations for their actions.

Several concerned individuals contacted the FDA for clarification of the Armour situation and received a prepared statement in response. A copy of the FDA’s letter explaining the government’s stance was posted to metabolism.com by an involved member. After studying the letter I believe I can offer a good explanation for the situation. The explanation, as I see it, is grounded in the fact that several thyroid medications such as Armour Thyroid but also including synthetic t4 medications like Synthroid, existed before the FDA was given full regulatory power. In 1973 the Supreme Court empowered the FDA to regulate the use of prescription medications in the U.S.. This meant that all prescription drugs would have to demonstrate to the FDA’s satisfaction, safety and efficacy for specific indications before pharmaceutical companies could promote the use of their drugs. Medications like Synthroid and Armour, already vital components of medical therapy for years before 1973 entered a grey area of legitimacy after that time.

Just a few years ago, I was astounded to hear from my pharmaceutical representatives that Synthroid faced being banned by the FDA since it never provided the FDA with the type of documentation of safety and efficacy that all modern medications had. After 30 years the FDA decided it wanted to rescind the right of the drug manufacturer to promote this medication which was considered safe and effective way before the FDA achieved regulatory power. What followed was a tense year during which the manufacturer of Synthroid went through the costly and bureaucratically intricate process needed for FDA approval, which it ultimately won.

What I believe is happening now is a similar scenario with Armour Thyroid and other dessicated thyroid products. What convinced me of this is the wording in the FDA letter which refers to Armour Thyroid as an illegal drug. The FDA has put Armour on its Most Wanted List and is intimidating the manufacturer (and prescribing physicians) by implying the law is being broken by continuing to make and use this drug. In the case of Synthroid, which enjoys the full support by the medical community and provides millions of dollars in annual sales the financial equation was a “no-brainer” in favor of putting the money into the process to gain approval.

Not so for Armour Thyroid which has been defamed by the American Academy of Clinical Endocrinologists (AACE) and who’s use is much more limited and far less profitable to the manufacturer. I can imagine that the pharmaceutical company has already done the math and decided that not making Armour makes more financial sense that to continue making the “illegal” product and going through the FDA gauntlet for approval.

Where does that leave the patients who depend on dessicated thyroid preparations and the physicians who prescribe it? With no way to force the manufacturer to make the drug or to make the FDA to back down on its stance my guess is that Armour and related products will simply cease to exist and alternative prescriptions will have to be written. Please remember, I am the messenger here and do not sanction or in anyway condone what I see as the most likely outcome of this predicament. Perhaps by recognizing the existing reality a strategy can be developed to prevent this outcome.

Gary Pepper, M.D., Editor-in-Chief. Metabolism.com

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Dr. L. Mallette’s Advice on Handling the Armour Shortage

Lawrence Mallette, M.D., PhD, reports to us on how the Armour shortage has effected his practice, and shares with metabolism.com his advice on how to handle replacement therapy. We appreciate Dr. Mallette’s comments.

Dr. Mallette Writes:

The shortage of Armour Thyroid and other brands of thryoid extract has devastated my office. We have received over 300 requests for changes due to the shortage. We can’t get the other work done!

Synthetic T3 (Cytomel) at a dose of 5 to 10 mcg a day, together with a balancing amount of Synthroid or Levoxyl does the trick for most patients. Only a few find a distinct improvement on Armour versus Cytomel as a source of the T3 supplement. The symptoms experience by 50% of Synthroid- or Levoxyl- treated patients usually do not derive from the Synthroid itself, but from the lack of T3 in those preparations. This is possibly going to be the only work-around, as I’ll not go back to Armour until we have an explanation from Forest Pharma.

I the Federal Government (FDA) responsible for this shortage. Likely. They are criminally neglegent in that case.

Armour Thyroid Shortage a Nation Wide Problem

Samantha, Nurse Practitioner in New York reports on the effect the national shortage of dessicated thyroid products is having on health care in her area. My own experience is that the situation is getting worse here in Florida, as well. Nature Thyroid and Westhroid which we had hoped would replace Armour in this practice has also become unavailable. At this very minute our office administrator is calling every pharmacy and pharmaceutical mail order companies we have used, trying to locate a source of these products for this practice (8 endocrinologists who serve a large portion of South Florida). Switching people back to T4 because the desired dessicated thyroid medication is unavailable, seems unacceptable in the “best health care system in the world”.

I thought Samantha’s comments were vital to see:

Samantha writes:

I’m a nurse practitioner in NY, and find that our patients generally do better or Armour Thyroid than on the usual T4 products. As for Cale, it sounds as if he’s in love with BigPharma, but many conservative practitioners and dispensors abound, so take what he says with a grain of salt. I, several MDs and NPs and a DO of my acquaintance all use Armour Thy. ourselves, but have noticed a slight decrease in effectiveness since the reformulation. The real frustration is having to convert our patients back to Levothyroxine and Cytomel which many do not find nearly as helpful. Other brands such as wes-throid and nature-throid are now out of stock, (in our area) and so there is no real alternative. Some of our patients have even tried getting stocks from Canada, to no avail. When I last checked with Forest they had stocks of 120 and 360 dosages available, but most of our patients require much less. While I will still use Armour and prescribe it, when we can get it again – as will my colleagues mentioned above – we are thoroughly annoyed at Forest for the reformulation. Most people tolerated the product very well. Patients should not have to have their effective medication routines switched out from under them. No one wants to change horses mid-stream.