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.

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  • Lucy

    Dr. Pepper: I just discovered this site and your posts on the Armour shortage. There is a real possibility that the FDA is considering removing all natural thyroid medications from the market. If you go to http://www.savenaturalthyroid.com/ and link to either facebook or the yahoo group you will find the text of a disturbing letter FDA sent yesterday citing the “illegality” of the drugs, recommending only testing TSH for thyroid disorders, and stating that only synthetic thyroid medications are appropriate for treatment. As a physician I think you would lend great credibility to the efforts to stop this from happening if you could suggest tactics, inform other like-minded physicians and raise your voice. Thank you!

  • gina

    Dr Pepper, I am taking the liberty of posting the entire text of the email Lucy referred to, which is apparently a form letter. I am aware of at least two people who have received the identical communication from the FDA in response to their concerns about the continued availability of natural thyroid hormone. I think it is safe to assume that it expresses the official views of the agency with respect to treatment for hypothyroidism, despite the disclaimer at the end.
    =================================================================

    Thank you for your inquiry to the Division of Drug Information in Center for Drug Evaluation and Research at the Food and Drug Administration.
    To date, there is not an approved drug application for the natural desiccated thyroid products. Without an approved drug application, the safety and efficacy has not been established by the FDA. Companies marketing natural desiccated thyroid products are encouraged to submit a new drug application (NDA) for approval.
    The Federal Food, Drug, and Cosmetic Act generally requires that drugs marketed in the United States be shown to be both safe and effective prior to marketing and widespread use in the general population. Drugs that are marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling.
    However, for a variety of historical reasons, some drugs, mostly older products, continue to be marketed illegally in the United States without required FDA approval. Many healthcare providers are unaware of the unapproved status of these drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack FDA approval. Often these drugs are advertised in reputable medical journals or are included in widely used pharmaceutical references such as the Physicians’ Desk Reference (PDR).
    You may read more about FDA actions against unapproved products at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/default.htm

    Fortunately, there are approved drugs that are currently available. Thyroid medications require close monitoring because precise dosing is critical for effective control of hormone levels. Physicians make sure patients get the correct dose of medicine by performing physical examinations and regularly checking thyroid stimulating hormone (TSH) levels through simple blood tests.
    Medications for underactive thyroid work by replacing hormone that’s missing. The approved medication for this indication is levothyroxine sodium, which is identical to the natural thyroid hormone produced by the body. Examples of brand names for levothyroxine are Synthroid, Levoxyl, and Levothroid. These drugs may also be used in the management of thyroid cancer or other thyroid conditions. Tablets are usually taken once a day. Side effects mostly occur because of overdosage of the medication and can include nervousness, weight loss, rapid heart beat, irritability, and anxiety. Most patients with underactive thyroid need to take levothyroxine for a lifetime to maintain proper hormone levels. The safety of long-term use of levothyroxine is well-documented; however, patients need to have routine laboratory tests to be certain that the correct dose is prescribed for the underlying condition.
    It is advisable that you discuss with your doctor to determine which approved treatment is best suited for you.

    If, after reviewing this information, you have any unanswered questions, please contact the Division of Drug Information by phone (1-888-463-6332) or e-mail (druginfo@cder.fda.gov). Thank you again for your message.

    Division of Drug Information
    Center of Drug Evaluation and Research
    Food and Drug Administration
    kcd
    For up-to-date drug information, follow the FDA’s Division of Drug Information on Twitter at FDA_Drug_Info
    This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

  • Tamara Shurling

    I got the same form letter from the FDA. It is going to end up costing me more money to get the synthetic junk than Armour and I also have other health problems that when I was on the synthetics were worse. What are we as patients supposed to do now?

  • Is the corresponding dose for 30mg Armour Thyroid this:
    100 mcg of Synthroid and 5 mg of Cytomel

    Thank you very much. I just started on Armour 2.5 months ago and I can’t describe how much better I feel and have lost an amazing 6 pounds. But I now have some anxiety about how to switch to the drugs that are available.

    Thanks in advance.

  • marilyn hirsch

    When people are NOT aware of a problem..nothing can be done about it..It seems the newspapers are unwilling to go against those that supply them with money via ads etc..so how in the world can we get this Armour Thyroid situation in front of the public ..showing how money once again is influencing decisions …even if they are detrimental to the people..Newspapers, and magazines seems to be indifferent to letting the people know the benefits of this product, which has been around for so many years..because they cannot afford to lose the income from ads etc..so HOW in the world can we EVER get this matter ” out front?” I am so discouraged to see how the power of big money is ruling our country and our health..I am attempting once again to contact the New York Times,, even threatening to cancel our long-time subscription..afterall they are supposed to put the “news” out front for their readers to see…not being done!!I’ll keep in touch with any (if any results) are forthcoming! Marilyn Hirsch

  • Hank Frier

    I too have been switched back to Synthroid after several successful years of being on Armour. At this juncture it is too early to tell how this will impact me. Luckily, my physician had the foresight to also put me on Cytomel after I suggested this from my readings. The combination of Armour and Cytomel seemed to work quite well for me without any adverse events.

    This next is my opinion so take it as such. I believe the makers of Synthroid (Abbott Ross) in an attempt to increase their sales of Synthroid put pressure on the FDA to require the makers of Armour to submit an NDA. It is a devastatingly poor tactic by Abbott Ross but typical of this industry.

    It is unfortunate that the FDA is caught in the middle of this since by statute and law drugs must pass regulatory muster. Where the FDA has failed is in their lack of looking at the long past history of Armour, its lack of adverse events and its benefit/risk for those individuals that have been using this drug. As opposed to demanding an NDA from Forest Pharma they should have sat with them and reviewed the long history of this drug, the number of scripts written for this drug and even contacting those physicians/endocrinologists that have been prescribing it for their patients.

    The only safety question in my mind is does Armour ingestion, a foreign protein, cause an immune response. This would have been reported by the medical profession if that were the case. Secondly, historically, large segments of the population have been eating pig and pig organ meats for generations without ill affects. The ingestion of a purified material from pig (Armour thyroid a protein) is probably benign. The FDA scientists should know this and counsel their legal staff as to the benign nature of the drug.

    Hank

  • Joan Lee

    I have ordered Armour from Canada. Is it the same as we were getting here in the US?

  • Nancy Latimer

    Hank — you wrote “he combination of Armour and Cytomel seemed to work quite well for me without any adverse events.”

    Did you mean “he combination of Synthroid and Cytomel seemed to work quite well for me without any adverse events.”

    I can say that after almost 3 months on the generic Synthroid and generic Cytomel in the doses that I cited above –I have had a very positive experience. I was on 30 mg Armour –I switched to 100mg generic Synthroid and 5 generic Cytomel and am doing just fine. 100mg seemed a bit high based on my dosage calculation BUT I was warned that generic synthyroid needs a bit higher dosing…

    related blog of mine…
    http://neuronalbeauty.blogspot.com/2009/09/hormones-installment-2-thyroid-dont.html

  • gmomslittlerose

    I have quoted Marilyn Hirsch’s post below here for reference to what I am responding, said post dated October 15, 2009 12:44 PM.

    My response is that we will communicate any way we can to let the rest of America and the world know the truth about the death of perfectly good drugs – Armour Thyroid and other natural drugs for thyroid issues, which have not resulted in any “dangerousness” or adverse reactions reported to the FDA. We know Big Pharma can generate more money for themselves. What do you think the new “better” health plan is going to allow you to take for your thyroid issues? Not
    Armour or any other natural remedy. They are laying the ground work now to make many of us sicker so we’ll be prescribed more drugs for the symptoms the synthetic thyroid meds will cause. This is nothing less than criminal, and they should be prosecuted if anyone out there dares to go there. Can someone generate enough interest to get a judge to at least get Armour Thyroid back to its original form until there is a formal ruling after the evidence can be presented? If the FDA isn’t going to help, which is obvious,.than we should use the court system to help just as they have with so many other unfair tactics by big industries!

    My goal is to use my vehicle to get the word out via bumper stickers that will catch people’s eye and spread the word and sweatshirts and t-shirts!! Are you game?
    I’m working on slogans with not too many words, websites speaking the truth, including this one. My email is gmomslittlerose@yahoo.com. Let’s roll . . .

    Marilyn’s words that motivated me:
    marilyn hirsch on October 15th, 2009 at 12:44 pm
    When people are NOT aware of a problem..nothing can be done about it..It seems the newspapers are unwilling to go against those that supply them with money via ads etc..so how in the world can we get this Armour Thyroid situation in front of the public ..showing how money once again is influencing decisions …even if they are detrimental to the people..Newspapers, and magazines seems to be indifferent to letting the people know the benefits of this product, which has been around for so many years..because they cannot afford to lose the income from ads etc..so HOW in the world can we EVER get this matter ” out front?” I am so discouraged to see how the power of big money is ruling our country and our health..I am attempting once again to contact the New York Times,, even threatening to cancel our long-time subscription..afterall they are supposed to put the “news” out front for their readers to see…not being done!!I’ll keep in touch with any (if any results) are forthcoming! Marilyn Hirsch

  • Michell Baydal

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  • Felicia Hargrove

    I have underactive thyroid. My doctor prescribes armor for me but I have to have it compounded by a compound rx. It costs more but its worth it. That crap synthroid does
    nt work for me