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Oops. Let’s not blow this out of proportion!

A very overreactive rumor is being started as I type this about the FDA and Armour, and I think this whole topic needs to be leveled out. The rumor is as follows:

1) The FDA has stopped manufacture of all grandfathered drugs like Armour.
2) Armour will no longer be available at your local pharmacy

i.e. it’s being banned, discontinued, taken off the market, gotten rid off…you name it.

Now first let me clarify that all are totally and completely false. Forest Labs is still making Armour, and you can also find Armour at your local pharmacy, even if certain strengths are easier found than others.

Here is what is going on: In the January-February issue of the 2007 (i.e. a YEAR AGO) FDA Consumer Magazine, an article came out by Michelle Meadows titled The FDA Takes Action Against Unapproved Drugs. But this is NOT new news. This is based on the June 2006 release guidance by the FDA, called Marketed Unapproved Drugs–Compliance Policy Guide. What the FDA is doing is working to get unapproved drugs meet their approval guidelines.

What is an unapproved drug? For one, they are those drugs which were around before the FDA (Federal Drug Administration) came into existence in 1938, and these drugs were ‘grandfathered’ in with the subsequent FDA-approved drugs thereafter. (Armour is an example. Synthroid was too until it did what it took to be approved in 2002) Other examples, as explained in the January/February 2007 article, are when only one company may have approval to market a drug, but other companies are illegally marketing their versions of the drug without having gone through the FDA’s approval process. Another scenario is that a combination of ingredients is approved by the FDA, but a company is marketing a single ingredient without approval.

The article also clearly states: Before pursuing regulatory action against unapproved drugs, the FDA plans to consider the effects on the public health, including whether the product is medically necessary. The agency recognizes that some unapproved therapies offer benefits. An example is Phenobarbital, a drug used to control seizures. In some cases, FDA action requiring drug approvals will be gradual to avoid shortages of medically necessary products. In other words, whenever the day may come that Forest Labs is asked that Armour meet the regulations of the FDA, the process will be gradual and Forest will be given a fair deadline to do what it takes.

Kathy, a pharmacist with Forest Labs, reminds us that Armour has never been asked to go through that process (or they may not be admitting it yet so they can go through it in peace.). And if the day comes, they will do what it takes. Armour is a safe and life-giving product. And you bet your booties that even if it looked threatened some day, there would be a huge uprising from patients to stop it. But that’s not going to happen, just as it was for Synthroid where Abbott labs did what it took to be approved, and succeeded.

So, take heart: everything is fine. Armour is still being made. Your pharmacies still have it, even when some strengths are easier to come by than others. And I’ll keep you informed. And remember: I’ve always told you to stock up on your desiccated thyroid products anyway. 🙂

p.s. The root of the rumor comes from a recent recall by Forest Labs concerning its 3, 4 and 5 grain tablets, which had a 6-month potency problem, and a misunderstanding about it’s implications by individuals. Those tablets are currently scheduled to be out again by the end of January.

http://www.fda.gov/fdac/features/2007/107_drug.html
http://www.fda.gov/cder/guidance/6911fnl.pdf

***Want to spread the word and be your own thyroid patient advocate? Get your t-shirt here.

16 replies

The right way to find a good doctor!

A friend of mine, Kerry, recently confessed to me and a few friends that it was time to find a new doctor. Her normal one had been a disappointment for her far too many times. Time to move on.

And how she is moving on TOTALLY impresses me, and I think all of you reading this should consider this positively assertive and self-advocating strategy.

First, she scoured through her list of doctors on her insurance plan, and found one that looked promising. She called and spoke to his nurse on the phone. She then told us the following: I explained that I use Armour and refuse to change meds; I am VERY involved in my health; I watch my Frees carefully and don’t rely on the TSH at all since the feedback loop is interrupted by meds..etc. With that said, the nurse stated she would check with the doctor.

In other words, my friend Kerry refused to do what all of us have done most of our lives–approach the doctor passively. She clearly outlined who she is, where her intelligence is about her body, and that she expects a partnership, not a demi-god, one-sided dictatorship of what is right and what isn’t right for her health care.

She also stated that if this doctor didn’t come through, her next strategy was to write a letter about her health needs and how she wants to be very involved in her treatment, then fax it to every available doctor on her insurance list in her area and see if she gets someone calling.

MAJOR, HAND-CLAPPING BRAVO, Kerry!!

THAT, friends, is the way each and every thyroid patient should approach their health care: candid as to your beliefs about your treatment, and what you want from the doctor. And eventually, your assertive approach will produce a doctor who is going to be a gem for you! Remember: it’s YOUR body and YOU live in it.

p.s. Without an insurance plan? Pull out the Yellow pages! And don’t hesitate to use parts of this Dear Doctor template letter to help you flesh out and compose your words or letter.

***WANT TO MAKE A FASHION STATEMENT ABOUT YOUR THYROID TREATMENT? Go HERE for a thyroid advocacy t-shirt. I dare you to wear it to your doctors appointment. (But if you don’t, wear it everywhere else. It does attract questions.)

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What happens to you….just happened to me

Last week, after hours, I called the office of the Nurse Practitioner I have used as my doctor for 5 years. I left my message–that I have had rising blood pressure and was curious what she would recommend. (And yes, I like her.)

I mentioned that I was slightly lowering my Armour, just in case the iodine I had been giving myself for a year was now causing my Armour amount to be too much (and contributing to my BP). I also mentioned that I had found many articles on the net about the benefit of taking CoQ10 for rising blood pressure…plus the fact that low levels of potassium and magnesium may place a role in at least 50% of those with rising blood pressure. I also asked if I could be sent lab papers so I can test my potassium and magnesium levels. I was curious.

Last Monday, the office called. It was the nurse under the physician that my NP works under, and whom I was FAR less impressed by. She explained that I would now be under his care, since blood pressure doesn’t fall under her specialty–female hormones. (first inner alarm).

Next, she says that the doc feels there is “no strong research” that CoQ10 will help me. (second inner alarm) I replied that there’s “no strong research” that Armour turns the lives around of thyroid patients, yet it does. Cough.

Finally, she stated that she doubts he will feel “comfortable” with letting me test my potassium and magnesium (final alarm). Excuse me…HE would not feel comfortable for me to know what my levels were? HE would not feel comfortable?? WHO’S BODY ARE WE TALKING ABOUT HERE?!?

And today…I received the lab papers I was to use…and all he checked were electrolytes….and TSH. Thud. Granted, there is a relationship between electrolytes and blood pressure…but I was appalled that he gave no respect to my request to know my potassium and magnesium levels….and wanted to test the WORST and most unreliable “thyroid” test there is.

I have tossed those lab papers…and I am making an appointment with a new doctor…one I have heard about from another patient….and who has a reputation of listening, not simply dictating.

p.s. I’m back on my regular amount of Armour. And..my blood pressure has fallen to a respectable level: 125/74 tonite…and 105/69 the other night. What did it? Probably the release of stress from letting go of some responsibilities. I’m also making sure I take a full spectrum of minerals, CoQ10, and I’m back to walking aerobically at least 4 times a week. And finally, I’ve been using a tablespoon of apple cider vinegar (acv) daily with 1/4 tsp baking soda for over two weeks. The acv has done wonders for my husband’s FORMERLY poor digestive issues….and there’s evidence it helps control blood pressure in two weeks!! (Remember: these blog posts are ONLY for comments. Want to talk to others? See the TALK TO OTHERS link on any STTM page.)

4 replies